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Osteoporosis Screening Not Supported for Men

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Osteoporosis Screening Not Supported for Men

New federal recommendations on screening for osteoporosis provide more detail on when to screen women younger than age 65 years and – for the first time – point to a lack of data to guide screening decisions in men.

The U.S. Preventive Services Task Force updated its 2002 recommendations on osteoporosis screening to call for routine screening in all women aged 65 years or older and in any younger women whose fracture risk is equal to or greater than that of a 65-year-old white woman who has no additional risk factors (equivalent to a 9.3% or greater risk of fracture within 10 years). Previously, women younger than 65 years would be screened if they were at least 60 years old with risk factors for fracture.

The new recommendations were posted on the USPSTF Web site (www.uspreventiveservicestaskforce.org/uspstf10/osteoporosis/osteors.htm

For the first time, the USPSTF evaluated the evidence for osteoporosis screening in men and found insufficient evidence to form any recommendation, Dr. Ned Colange, chair of the USPSTF, said in an interview. There's not enough evidence to recommend osteoporosis screening or treatment in men with no prior osteoporotic fractures, and “there's certainly not enough evidence to say, 'Don't' do it,” he said. “While there's not a call to action, that's an important call for research,” added Dr. Colange, who is president and CEO of the Colorado Trust Foundation, Denver.

In women, the recommendations do not say to stop osteoporosis screening at any specific age because the risk of fractures continues to increase with advancing age, and the minimal potential harms of treatment remain small. Clinicians who are considering treating older patients with significant morbidity should consider that the benefits of osteoporosis treatment eake 18-24 months af emerge.

To predict an individual's risk for osteoporotic fracture, the USPSTF used the online FRAX tool, developed by the World Health Organization and the National Osteoporosis Foundation. “The nice thing about the FRAX calculator is, the patient herself can determine that risk. It's available online. It uses measures that the woman should know,” Dr. Colange said.

The FRAX tool estimates 10-year fracture risk based on easily obtained information such as age, body mass index (BMI), parental fracture history, and tobacco or alcohol use. It asks about results of dual-energy x-ray absorptiometry scans but does not require this information.

Younger women can reach the new threshold for screening because of various risk factors. For example, a white woman would qualify for screening if she is 50 years old, smokes, drinks alcohol daily, has a BMI less than 21, and has a parental history of fracture. A 55-year-old white woman would need only a parental fracture history to warrant osteoporosis screening. A 60-year-old white woman who smokes and drinks alcohol daily would fit the 10-year-risk profile for screening.

White women are more likely than women of other races to develop osteoporosis and fractures. Although there are fewer data on nonwhite women, the USPSTF recommended screening all women at age 65 because the consequences of failing to identify and treat low bone-mineral density are considerable, and the potential risks of treatment are small,

There are not enough data to recommend when to rescreen women without osteoporosis on their initial screen, the USPSTF stated, but at least a 2-year interval would be needed to assess a change in bone density and perhaps longer for better prediction of fracture risk.

The new recommendations are based on a 2010 review of studies published since 2002; the review was done by a team at the University of Oregon Health and Science University's Evidence-Based Practice Center in Portland.

An estimated 12 million Americans aged 50 years or older will have osteoporosis in 2012. Among postmenopausal women, 15% will develop a hip fracture during their lifetime, 25% will develop a vertebral deformity, and osteoporotic fractures of any kind will affect 50%.

In a new effort at transparency, the USPSTF first published a draft of the new recommendations online in the summer of 2010 and invited public comment. They received more than 50 comments from individuals, professional organizations, advocates, and pharmaceutical companies, Dr. Colange said, which led the USPSTF to clarify its approach to fracture risk assessment in the final version.

Dr. Colange said he has no pertinent conflicts of interest.

Views on the News

Screening Calculations Now Needed

For clinicians, the biggest change in the new screening recommendations may be the need to calculate the 10-year fracture risk in women younger than 65, two experts suggested in interviews.

“They will need to know what tools are out there to be able to figure out whether a younger person is at equal to or greater risk than a 65-year-old woman with no additional risk factors,” Dr. Carolyn J. Crandall said.

 

 

The online FRAX calculator that was used by the USPSTF is a “really good tool” for this purpose, she said. “Clinicians will have to access that tool in their clinics, which means they will either need Internet access at some point, or else they can download versions that are available for iPhone, or print versions”

Dr. Edward S. Leib also commended inclusion of the FRAX tool in the guidelines, but cautioned that it has some weaknesses that were discussed at a November 2010 “position development conference” conducted jointly by the International Osteoporosis Foundation and the International Society for Clinical Densitometry.

Some important risk factors that could affect the 10-year fracture risk would not necessarily be reflected in the FRAX calculation, he said. In addition, the FRAX tool is based on an international model, and although it included U.S. databases, the calculations may not reflect risks in regional populations.

Both Dr. Crandall and Dr. Leib also commended the USPSTF for acknowledging the need for more research in men, but Dr. Leib had hoped for more guidance. “It is known that the fracture risk in men who are age 75 is about equivalent to women who are age 65. I would have hoped that the USPSTF would have recommended screening at that age” despite the lack of primary prevention trials, he said.

DR. CRANDALL is professor of medicine at the University of California, Los Angeles. DR. LEIB is professor of medicine at the University of Vermont, Burlington. Hoth said hey have no pertinent conflicts of interest.

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New federal recommendations on screening for osteoporosis provide more detail on when to screen women younger than age 65 years and – for the first time – point to a lack of data to guide screening decisions in men.

The U.S. Preventive Services Task Force updated its 2002 recommendations on osteoporosis screening to call for routine screening in all women aged 65 years or older and in any younger women whose fracture risk is equal to or greater than that of a 65-year-old white woman who has no additional risk factors (equivalent to a 9.3% or greater risk of fracture within 10 years). Previously, women younger than 65 years would be screened if they were at least 60 years old with risk factors for fracture.

The new recommendations were posted on the USPSTF Web site (www.uspreventiveservicestaskforce.org/uspstf10/osteoporosis/osteors.htm

For the first time, the USPSTF evaluated the evidence for osteoporosis screening in men and found insufficient evidence to form any recommendation, Dr. Ned Colange, chair of the USPSTF, said in an interview. There's not enough evidence to recommend osteoporosis screening or treatment in men with no prior osteoporotic fractures, and “there's certainly not enough evidence to say, 'Don't' do it,” he said. “While there's not a call to action, that's an important call for research,” added Dr. Colange, who is president and CEO of the Colorado Trust Foundation, Denver.

In women, the recommendations do not say to stop osteoporosis screening at any specific age because the risk of fractures continues to increase with advancing age, and the minimal potential harms of treatment remain small. Clinicians who are considering treating older patients with significant morbidity should consider that the benefits of osteoporosis treatment eake 18-24 months af emerge.

To predict an individual's risk for osteoporotic fracture, the USPSTF used the online FRAX tool, developed by the World Health Organization and the National Osteoporosis Foundation. “The nice thing about the FRAX calculator is, the patient herself can determine that risk. It's available online. It uses measures that the woman should know,” Dr. Colange said.

The FRAX tool estimates 10-year fracture risk based on easily obtained information such as age, body mass index (BMI), parental fracture history, and tobacco or alcohol use. It asks about results of dual-energy x-ray absorptiometry scans but does not require this information.

Younger women can reach the new threshold for screening because of various risk factors. For example, a white woman would qualify for screening if she is 50 years old, smokes, drinks alcohol daily, has a BMI less than 21, and has a parental history of fracture. A 55-year-old white woman would need only a parental fracture history to warrant osteoporosis screening. A 60-year-old white woman who smokes and drinks alcohol daily would fit the 10-year-risk profile for screening.

White women are more likely than women of other races to develop osteoporosis and fractures. Although there are fewer data on nonwhite women, the USPSTF recommended screening all women at age 65 because the consequences of failing to identify and treat low bone-mineral density are considerable, and the potential risks of treatment are small,

There are not enough data to recommend when to rescreen women without osteoporosis on their initial screen, the USPSTF stated, but at least a 2-year interval would be needed to assess a change in bone density and perhaps longer for better prediction of fracture risk.

The new recommendations are based on a 2010 review of studies published since 2002; the review was done by a team at the University of Oregon Health and Science University's Evidence-Based Practice Center in Portland.

An estimated 12 million Americans aged 50 years or older will have osteoporosis in 2012. Among postmenopausal women, 15% will develop a hip fracture during their lifetime, 25% will develop a vertebral deformity, and osteoporotic fractures of any kind will affect 50%.

In a new effort at transparency, the USPSTF first published a draft of the new recommendations online in the summer of 2010 and invited public comment. They received more than 50 comments from individuals, professional organizations, advocates, and pharmaceutical companies, Dr. Colange said, which led the USPSTF to clarify its approach to fracture risk assessment in the final version.

Dr. Colange said he has no pertinent conflicts of interest.

Views on the News

Screening Calculations Now Needed

For clinicians, the biggest change in the new screening recommendations may be the need to calculate the 10-year fracture risk in women younger than 65, two experts suggested in interviews.

“They will need to know what tools are out there to be able to figure out whether a younger person is at equal to or greater risk than a 65-year-old woman with no additional risk factors,” Dr. Carolyn J. Crandall said.

 

 

The online FRAX calculator that was used by the USPSTF is a “really good tool” for this purpose, she said. “Clinicians will have to access that tool in their clinics, which means they will either need Internet access at some point, or else they can download versions that are available for iPhone, or print versions”

Dr. Edward S. Leib also commended inclusion of the FRAX tool in the guidelines, but cautioned that it has some weaknesses that were discussed at a November 2010 “position development conference” conducted jointly by the International Osteoporosis Foundation and the International Society for Clinical Densitometry.

Some important risk factors that could affect the 10-year fracture risk would not necessarily be reflected in the FRAX calculation, he said. In addition, the FRAX tool is based on an international model, and although it included U.S. databases, the calculations may not reflect risks in regional populations.

Both Dr. Crandall and Dr. Leib also commended the USPSTF for acknowledging the need for more research in men, but Dr. Leib had hoped for more guidance. “It is known that the fracture risk in men who are age 75 is about equivalent to women who are age 65. I would have hoped that the USPSTF would have recommended screening at that age” despite the lack of primary prevention trials, he said.

DR. CRANDALL is professor of medicine at the University of California, Los Angeles. DR. LEIB is professor of medicine at the University of Vermont, Burlington. Hoth said hey have no pertinent conflicts of interest.

New federal recommendations on screening for osteoporosis provide more detail on when to screen women younger than age 65 years and – for the first time – point to a lack of data to guide screening decisions in men.

The U.S. Preventive Services Task Force updated its 2002 recommendations on osteoporosis screening to call for routine screening in all women aged 65 years or older and in any younger women whose fracture risk is equal to or greater than that of a 65-year-old white woman who has no additional risk factors (equivalent to a 9.3% or greater risk of fracture within 10 years). Previously, women younger than 65 years would be screened if they were at least 60 years old with risk factors for fracture.

The new recommendations were posted on the USPSTF Web site (www.uspreventiveservicestaskforce.org/uspstf10/osteoporosis/osteors.htm

For the first time, the USPSTF evaluated the evidence for osteoporosis screening in men and found insufficient evidence to form any recommendation, Dr. Ned Colange, chair of the USPSTF, said in an interview. There's not enough evidence to recommend osteoporosis screening or treatment in men with no prior osteoporotic fractures, and “there's certainly not enough evidence to say, 'Don't' do it,” he said. “While there's not a call to action, that's an important call for research,” added Dr. Colange, who is president and CEO of the Colorado Trust Foundation, Denver.

In women, the recommendations do not say to stop osteoporosis screening at any specific age because the risk of fractures continues to increase with advancing age, and the minimal potential harms of treatment remain small. Clinicians who are considering treating older patients with significant morbidity should consider that the benefits of osteoporosis treatment eake 18-24 months af emerge.

To predict an individual's risk for osteoporotic fracture, the USPSTF used the online FRAX tool, developed by the World Health Organization and the National Osteoporosis Foundation. “The nice thing about the FRAX calculator is, the patient herself can determine that risk. It's available online. It uses measures that the woman should know,” Dr. Colange said.

The FRAX tool estimates 10-year fracture risk based on easily obtained information such as age, body mass index (BMI), parental fracture history, and tobacco or alcohol use. It asks about results of dual-energy x-ray absorptiometry scans but does not require this information.

Younger women can reach the new threshold for screening because of various risk factors. For example, a white woman would qualify for screening if she is 50 years old, smokes, drinks alcohol daily, has a BMI less than 21, and has a parental history of fracture. A 55-year-old white woman would need only a parental fracture history to warrant osteoporosis screening. A 60-year-old white woman who smokes and drinks alcohol daily would fit the 10-year-risk profile for screening.

White women are more likely than women of other races to develop osteoporosis and fractures. Although there are fewer data on nonwhite women, the USPSTF recommended screening all women at age 65 because the consequences of failing to identify and treat low bone-mineral density are considerable, and the potential risks of treatment are small,

There are not enough data to recommend when to rescreen women without osteoporosis on their initial screen, the USPSTF stated, but at least a 2-year interval would be needed to assess a change in bone density and perhaps longer for better prediction of fracture risk.

The new recommendations are based on a 2010 review of studies published since 2002; the review was done by a team at the University of Oregon Health and Science University's Evidence-Based Practice Center in Portland.

An estimated 12 million Americans aged 50 years or older will have osteoporosis in 2012. Among postmenopausal women, 15% will develop a hip fracture during their lifetime, 25% will develop a vertebral deformity, and osteoporotic fractures of any kind will affect 50%.

In a new effort at transparency, the USPSTF first published a draft of the new recommendations online in the summer of 2010 and invited public comment. They received more than 50 comments from individuals, professional organizations, advocates, and pharmaceutical companies, Dr. Colange said, which led the USPSTF to clarify its approach to fracture risk assessment in the final version.

Dr. Colange said he has no pertinent conflicts of interest.

Views on the News

Screening Calculations Now Needed

For clinicians, the biggest change in the new screening recommendations may be the need to calculate the 10-year fracture risk in women younger than 65, two experts suggested in interviews.

“They will need to know what tools are out there to be able to figure out whether a younger person is at equal to or greater risk than a 65-year-old woman with no additional risk factors,” Dr. Carolyn J. Crandall said.

 

 

The online FRAX calculator that was used by the USPSTF is a “really good tool” for this purpose, she said. “Clinicians will have to access that tool in their clinics, which means they will either need Internet access at some point, or else they can download versions that are available for iPhone, or print versions”

Dr. Edward S. Leib also commended inclusion of the FRAX tool in the guidelines, but cautioned that it has some weaknesses that were discussed at a November 2010 “position development conference” conducted jointly by the International Osteoporosis Foundation and the International Society for Clinical Densitometry.

Some important risk factors that could affect the 10-year fracture risk would not necessarily be reflected in the FRAX calculation, he said. In addition, the FRAX tool is based on an international model, and although it included U.S. databases, the calculations may not reflect risks in regional populations.

Both Dr. Crandall and Dr. Leib also commended the USPSTF for acknowledging the need for more research in men, but Dr. Leib had hoped for more guidance. “It is known that the fracture risk in men who are age 75 is about equivalent to women who are age 65. I would have hoped that the USPSTF would have recommended screening at that age” despite the lack of primary prevention trials, he said.

DR. CRANDALL is professor of medicine at the University of California, Los Angeles. DR. LEIB is professor of medicine at the University of Vermont, Burlington. Hoth said hey have no pertinent conflicts of interest.

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Knee Rehab May Avoid Cartilage Repair Surgery

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Knee Rehab May Avoid Cartilage Repair Surgery

Major Finding: A 3-month program of intensive knee rehabilitation produced a significant, 30% improvement in knee extension and flexion in patients with articular cartilage lesions who were scheduled for repair surgery. After the program ended, 64% of participants said they no longer needed immediate surgery.

Data Source: Single-center study of 48 patients with articular cartilage lesions.

Disclosures: Dr. Risberg said she had no conflicts of interest.

BRUSSELS – A carefully designed, 3-month program of rehabilitation exercise and education in patients with articular cartilage lesions who were scheduled for cartilage repair surgery led to significant improvements in knee function in a single-center study with 48 patients.

Following the 3-month rehabilitation intervention, 64% of the patients said they no longer needed immediate surgery, said May Arna Risberg, Ph.D.

“I believe this [rehabilitation] program works for these patients. We will publish the program, and continue to use it ourselves, and we hope others will use it,” said Dr. Risberg, professor of sports medicine at the Norwegian School of Sport Sciences in Oslo. Gradually increasing knee loading using an individualized schedule may explain the rehab program's success, she said.

“Patients with cartilage lesions are very different from osteoarthritis patients. You need to go much slower with progression of their knee loading. Rehab for cartilage needs to be slow and long,” she said in an interview.

All 48 patients in the study had undergone prior rehab sessions run by other clinicians, but aside from the focus on a gradual pace, an emphasis on using knee loading to guide the program's intensity, and a strong education component, the rehab program tested by Dr. Risberg didn't involve any novel approaches or exercise regimens.

Participating patients attended rehab sessions of the Oslo CARE (cartilage, active, rehab, and education) program an average of twice a week. Sessions included warm-up stretches, gait retraining, neuromuscular exercises, step-up and step-down exercises, and strength exercise for knee and hip muscles. Both the step and strength exercises featured gradually increasing loading over time. The program also included educational sessions and materials.

The study enrolled patients who had a focal femoral-condyle defect in the articular cartilage of one knee, diagnosed by arthroscopy, and who were scheduled for repair surgery. Their age averaged 34 years (range, 17-50); 70% were men, and 84% had a medial femoral-condyle lesion. Participants had had their symptoms for an average of 47 months prior to the study.

Analysis of training diaries and responses in biweekly questionnaires showed that 79% of participants adhered to their rehab regimens, and 88% had follow-up assessments an average of 104 days after they entered the study.

At follow-up, participants averaged a 30% improvement over baseline in both extension and flexion of their injured knee, Dr. Risberg reported at the meeting, sponsored by the Osteoarthritis Research Society International. They also averaged improvements of 21%, 31%, and 37% in the triple, crossover, and one-leg hop tests, respectively, compared with baseline, all statistically significant increases.

They also had significant improvements in measures of pain, activity, and quality of life. Dr. Risberg cited the finding that nearly two-thirds of patients said they no longer needed immediate knee surgery as the best demonstration of their improvement.

She cautioned that despite completing the 3-month program, some patients had no significant response to their rehabilitation, and that additional studies should test the program in more patients with longer follow-up.

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Major Finding: A 3-month program of intensive knee rehabilitation produced a significant, 30% improvement in knee extension and flexion in patients with articular cartilage lesions who were scheduled for repair surgery. After the program ended, 64% of participants said they no longer needed immediate surgery.

Data Source: Single-center study of 48 patients with articular cartilage lesions.

Disclosures: Dr. Risberg said she had no conflicts of interest.

BRUSSELS – A carefully designed, 3-month program of rehabilitation exercise and education in patients with articular cartilage lesions who were scheduled for cartilage repair surgery led to significant improvements in knee function in a single-center study with 48 patients.

Following the 3-month rehabilitation intervention, 64% of the patients said they no longer needed immediate surgery, said May Arna Risberg, Ph.D.

“I believe this [rehabilitation] program works for these patients. We will publish the program, and continue to use it ourselves, and we hope others will use it,” said Dr. Risberg, professor of sports medicine at the Norwegian School of Sport Sciences in Oslo. Gradually increasing knee loading using an individualized schedule may explain the rehab program's success, she said.

“Patients with cartilage lesions are very different from osteoarthritis patients. You need to go much slower with progression of their knee loading. Rehab for cartilage needs to be slow and long,” she said in an interview.

All 48 patients in the study had undergone prior rehab sessions run by other clinicians, but aside from the focus on a gradual pace, an emphasis on using knee loading to guide the program's intensity, and a strong education component, the rehab program tested by Dr. Risberg didn't involve any novel approaches or exercise regimens.

Participating patients attended rehab sessions of the Oslo CARE (cartilage, active, rehab, and education) program an average of twice a week. Sessions included warm-up stretches, gait retraining, neuromuscular exercises, step-up and step-down exercises, and strength exercise for knee and hip muscles. Both the step and strength exercises featured gradually increasing loading over time. The program also included educational sessions and materials.

The study enrolled patients who had a focal femoral-condyle defect in the articular cartilage of one knee, diagnosed by arthroscopy, and who were scheduled for repair surgery. Their age averaged 34 years (range, 17-50); 70% were men, and 84% had a medial femoral-condyle lesion. Participants had had their symptoms for an average of 47 months prior to the study.

Analysis of training diaries and responses in biweekly questionnaires showed that 79% of participants adhered to their rehab regimens, and 88% had follow-up assessments an average of 104 days after they entered the study.

At follow-up, participants averaged a 30% improvement over baseline in both extension and flexion of their injured knee, Dr. Risberg reported at the meeting, sponsored by the Osteoarthritis Research Society International. They also averaged improvements of 21%, 31%, and 37% in the triple, crossover, and one-leg hop tests, respectively, compared with baseline, all statistically significant increases.

They also had significant improvements in measures of pain, activity, and quality of life. Dr. Risberg cited the finding that nearly two-thirds of patients said they no longer needed immediate knee surgery as the best demonstration of their improvement.

She cautioned that despite completing the 3-month program, some patients had no significant response to their rehabilitation, and that additional studies should test the program in more patients with longer follow-up.

Major Finding: A 3-month program of intensive knee rehabilitation produced a significant, 30% improvement in knee extension and flexion in patients with articular cartilage lesions who were scheduled for repair surgery. After the program ended, 64% of participants said they no longer needed immediate surgery.

Data Source: Single-center study of 48 patients with articular cartilage lesions.

Disclosures: Dr. Risberg said she had no conflicts of interest.

BRUSSELS – A carefully designed, 3-month program of rehabilitation exercise and education in patients with articular cartilage lesions who were scheduled for cartilage repair surgery led to significant improvements in knee function in a single-center study with 48 patients.

Following the 3-month rehabilitation intervention, 64% of the patients said they no longer needed immediate surgery, said May Arna Risberg, Ph.D.

“I believe this [rehabilitation] program works for these patients. We will publish the program, and continue to use it ourselves, and we hope others will use it,” said Dr. Risberg, professor of sports medicine at the Norwegian School of Sport Sciences in Oslo. Gradually increasing knee loading using an individualized schedule may explain the rehab program's success, she said.

“Patients with cartilage lesions are very different from osteoarthritis patients. You need to go much slower with progression of their knee loading. Rehab for cartilage needs to be slow and long,” she said in an interview.

All 48 patients in the study had undergone prior rehab sessions run by other clinicians, but aside from the focus on a gradual pace, an emphasis on using knee loading to guide the program's intensity, and a strong education component, the rehab program tested by Dr. Risberg didn't involve any novel approaches or exercise regimens.

Participating patients attended rehab sessions of the Oslo CARE (cartilage, active, rehab, and education) program an average of twice a week. Sessions included warm-up stretches, gait retraining, neuromuscular exercises, step-up and step-down exercises, and strength exercise for knee and hip muscles. Both the step and strength exercises featured gradually increasing loading over time. The program also included educational sessions and materials.

The study enrolled patients who had a focal femoral-condyle defect in the articular cartilage of one knee, diagnosed by arthroscopy, and who were scheduled for repair surgery. Their age averaged 34 years (range, 17-50); 70% were men, and 84% had a medial femoral-condyle lesion. Participants had had their symptoms for an average of 47 months prior to the study.

Analysis of training diaries and responses in biweekly questionnaires showed that 79% of participants adhered to their rehab regimens, and 88% had follow-up assessments an average of 104 days after they entered the study.

At follow-up, participants averaged a 30% improvement over baseline in both extension and flexion of their injured knee, Dr. Risberg reported at the meeting, sponsored by the Osteoarthritis Research Society International. They also averaged improvements of 21%, 31%, and 37% in the triple, crossover, and one-leg hop tests, respectively, compared with baseline, all statistically significant increases.

They also had significant improvements in measures of pain, activity, and quality of life. Dr. Risberg cited the finding that nearly two-thirds of patients said they no longer needed immediate knee surgery as the best demonstration of their improvement.

She cautioned that despite completing the 3-month program, some patients had no significant response to their rehabilitation, and that additional studies should test the program in more patients with longer follow-up.

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Osteoarthritis: Disease or Late-Life Benchmark?

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Osteoarthritis is a well-accepted diagnosis among physicians for a painful and stiff joint, but the other day I spoke with a rheumatologist who has a very different take on how to characterize these symptoms.

Photo credit: Flickr user Jeff Rasansky (Creative Commons)
    

Dr. Nortin M. Hadler, a professor of medicine at the University of North Carolina, Chapel Hill, insisted on calling the condition “regional joint pain.” Calling it osteoarthritis reflected the over-medicalization that modern industrialized society imposes on ubiquitous conditions that shouldn’t really qualify as bona fide disorders, he said.

Dr. Hadler’s contention is that having a joint or two grow painful and less functional over the course of more than half a lifetime was inevitable for most people, as unavoidable as “headache and heartache,” he told me. “There is no person after midlife who does not have substantial regional joint pain,” and the older they get the more this colors their life. “It is abnormal [for a middle-aged or elderly person] to go a year without important back pain, or to go 3 years without important knee pain,” he said.

Dr. Hadler added that when people seek out medical care for such routine aches and pains of aging, there is really something else going on in the patient’s life. “The regional disorder can be viewed as a surrogate complaint,” he said. A patient might say “My knee is hurting,” but the reality is that their complaint reflects a broader difficulty they’re having.

He described a study he ran that compared two sets of similar elderly people with the same complaint of knee pain. One group had sought medical care, the other hadn’t. What also distinguished the two groups were their levels of loneliness and depression, which were both higher among those who went to see a physician, he said.

Removing osteoarthritis from the category of pathology and reclassifying it as a more benign and routine part of aging would, no doubt, come as a surprise to many physicians who specialize in studying and treating it.  Last September, I covered the annual meeting of the Osteoarthritis Reasearch Society International (OARSI) and, in counterpoint to Dr. Hadler’s contention, this meeting was attended by hundreds of experts and specialists who would be happy to detail the pathophysiologic processes that appear to define osteoarthritis. Back then, I posted an entry on this blog on the intriguing hypothesis that joint trauma (a severely twisted knee, for example) sets off an acute inflammatory cascade that can have profound long-term consequences for joint health and osteoarthritis development. This notion raises the possibility that a quick and potent anti-inflammatory intervention could help prevent or attenuate the longer-term irreversible damage, the same way that prompt treatment of a myocardial infarction can limit damage to the heart.

My guess is that the reality falls somewhere in between. I’m sure Dr. Hadler is right about some people. Their joint pain is really not too disabling and is something that many other people would just work through, but because of an overlay of coincident emotional and psychiatric issues, they seek medical care and in many cases find physicians who are willing, as Dr. Hadler puts it, to medicalize life and “create a society of the walking wounded.”

On the other hand, I also believe that as the result of some unusual trauma or bad genetics a person can develop a deteriorated and painful joint that is truly pathologic and outside the scope of normal wear and tear and really needs medical attention.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Osteoarthritis is a well-accepted diagnosis among physicians for a painful and stiff joint, but the other day I spoke with a rheumatologist who has a very different take on how to characterize these symptoms.

Photo credit: Flickr user Jeff Rasansky (Creative Commons)
    

Dr. Nortin M. Hadler, a professor of medicine at the University of North Carolina, Chapel Hill, insisted on calling the condition “regional joint pain.” Calling it osteoarthritis reflected the over-medicalization that modern industrialized society imposes on ubiquitous conditions that shouldn’t really qualify as bona fide disorders, he said.

Dr. Hadler’s contention is that having a joint or two grow painful and less functional over the course of more than half a lifetime was inevitable for most people, as unavoidable as “headache and heartache,” he told me. “There is no person after midlife who does not have substantial regional joint pain,” and the older they get the more this colors their life. “It is abnormal [for a middle-aged or elderly person] to go a year without important back pain, or to go 3 years without important knee pain,” he said.

Dr. Hadler added that when people seek out medical care for such routine aches and pains of aging, there is really something else going on in the patient’s life. “The regional disorder can be viewed as a surrogate complaint,” he said. A patient might say “My knee is hurting,” but the reality is that their complaint reflects a broader difficulty they’re having.

He described a study he ran that compared two sets of similar elderly people with the same complaint of knee pain. One group had sought medical care, the other hadn’t. What also distinguished the two groups were their levels of loneliness and depression, which were both higher among those who went to see a physician, he said.

Removing osteoarthritis from the category of pathology and reclassifying it as a more benign and routine part of aging would, no doubt, come as a surprise to many physicians who specialize in studying and treating it.  Last September, I covered the annual meeting of the Osteoarthritis Reasearch Society International (OARSI) and, in counterpoint to Dr. Hadler’s contention, this meeting was attended by hundreds of experts and specialists who would be happy to detail the pathophysiologic processes that appear to define osteoarthritis. Back then, I posted an entry on this blog on the intriguing hypothesis that joint trauma (a severely twisted knee, for example) sets off an acute inflammatory cascade that can have profound long-term consequences for joint health and osteoarthritis development. This notion raises the possibility that a quick and potent anti-inflammatory intervention could help prevent or attenuate the longer-term irreversible damage, the same way that prompt treatment of a myocardial infarction can limit damage to the heart.

My guess is that the reality falls somewhere in between. I’m sure Dr. Hadler is right about some people. Their joint pain is really not too disabling and is something that many other people would just work through, but because of an overlay of coincident emotional and psychiatric issues, they seek medical care and in many cases find physicians who are willing, as Dr. Hadler puts it, to medicalize life and “create a society of the walking wounded.”

On the other hand, I also believe that as the result of some unusual trauma or bad genetics a person can develop a deteriorated and painful joint that is truly pathologic and outside the scope of normal wear and tear and really needs medical attention.

—Mitchel Zoler (on Twitter @mitchelzoler)

Osteoarthritis is a well-accepted diagnosis among physicians for a painful and stiff joint, but the other day I spoke with a rheumatologist who has a very different take on how to characterize these symptoms.

Photo credit: Flickr user Jeff Rasansky (Creative Commons)
    

Dr. Nortin M. Hadler, a professor of medicine at the University of North Carolina, Chapel Hill, insisted on calling the condition “regional joint pain.” Calling it osteoarthritis reflected the over-medicalization that modern industrialized society imposes on ubiquitous conditions that shouldn’t really qualify as bona fide disorders, he said.

Dr. Hadler’s contention is that having a joint or two grow painful and less functional over the course of more than half a lifetime was inevitable for most people, as unavoidable as “headache and heartache,” he told me. “There is no person after midlife who does not have substantial regional joint pain,” and the older they get the more this colors their life. “It is abnormal [for a middle-aged or elderly person] to go a year without important back pain, or to go 3 years without important knee pain,” he said.

Dr. Hadler added that when people seek out medical care for such routine aches and pains of aging, there is really something else going on in the patient’s life. “The regional disorder can be viewed as a surrogate complaint,” he said. A patient might say “My knee is hurting,” but the reality is that their complaint reflects a broader difficulty they’re having.

He described a study he ran that compared two sets of similar elderly people with the same complaint of knee pain. One group had sought medical care, the other hadn’t. What also distinguished the two groups were their levels of loneliness and depression, which were both higher among those who went to see a physician, he said.

Removing osteoarthritis from the category of pathology and reclassifying it as a more benign and routine part of aging would, no doubt, come as a surprise to many physicians who specialize in studying and treating it.  Last September, I covered the annual meeting of the Osteoarthritis Reasearch Society International (OARSI) and, in counterpoint to Dr. Hadler’s contention, this meeting was attended by hundreds of experts and specialists who would be happy to detail the pathophysiologic processes that appear to define osteoarthritis. Back then, I posted an entry on this blog on the intriguing hypothesis that joint trauma (a severely twisted knee, for example) sets off an acute inflammatory cascade that can have profound long-term consequences for joint health and osteoarthritis development. This notion raises the possibility that a quick and potent anti-inflammatory intervention could help prevent or attenuate the longer-term irreversible damage, the same way that prompt treatment of a myocardial infarction can limit damage to the heart.

My guess is that the reality falls somewhere in between. I’m sure Dr. Hadler is right about some people. Their joint pain is really not too disabling and is something that many other people would just work through, but because of an overlay of coincident emotional and psychiatric issues, they seek medical care and in many cases find physicians who are willing, as Dr. Hadler puts it, to medicalize life and “create a society of the walking wounded.”

On the other hand, I also believe that as the result of some unusual trauma or bad genetics a person can develop a deteriorated and painful joint that is truly pathologic and outside the scope of normal wear and tear and really needs medical attention.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Central Factors Seen as Key to Chronic Pain

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BETHESDA, Md. – When it comes to managing chronic pain, Dr. Daniel J. Clauw said physicians have been looking in the wrong places.

Dr. Daniel J. Clauw     

"There is no chronic pain state where degree of damage or inflammation in the periphery correlates well with level of pain. Yet, the diagnostic algorithms or paradigms that everyone uses for treating chronic pain still assume that all pain is nociceptive. What we see in the peripheral tissues is not necessarily what our patients are experiencing," said Dr. Clauw, director of the chronic pain and fatigue research center at the University of Michigan, Ann Arbor.

Historically, it has been assumed that when there was a disparity between peripheral findings and pain, psychological factors were at work. But the current view of chronic pain is that while it may originate from peripheral nociceptive input or nerve damage, central neuronal factors – at least some of them genetically determined – are nearly always playing a role in leading to interindividual differences in pain sensitivity, which are in turn closely associated with clinical outcomes.

For instance, population-based studies have shown that 30%-40% of individuals with radiographic evidence of severe damage from osteoarthritis are pain free, while 10% of those with normal radiographs have severe pain (Br. J. Rheumatol. 1997;36:726-8). Psychological factors explain very little of the variance between symptoms and structure (Arthritis Care Res. 1998;11:60-5), suggesting that central mechanisms involved in pain processing are at work, Dr. Clauw said at the workshop, sponsored by the University of Michigan and the National Institutes of Health.

Of course, individuals with osteoarthritis and rheumatoid arthritis will often have evidence of nociceptive input, while those with fibromyalgia have more prominent central factors. But no chronic pain state is solely due to any one of these mechanisms, he said.

"The scientific paradigm shift requires that we rethink everything from diagnostics and treatment approaches – which currently place an unjustified importance on treating peripheral factors," he said.

The new paradigm suggests that, regardless of the specific diagnosis, "central pain states" including fibromyalgia, rheumatoid arthritis, osteoarthritis, lupus, and low back pain all tend to share certain characteristics that can be better assessed by asking questions than by physical examination.

Showing patients a body diagram and asking them to label all the areas where they have pain is a simple assessment tool for multifocal pain. Also, ask about previous pain and other somatic symptoms such as fatigue, memory difficulty, mood disorders, and sleep disturbances, all common in the context of central pain but not with pain that is solely peripheral.

Is the pain triggered or exacerbated by stressors, such as psychological stress, infections, or physical trauma? Was there a salient stressor in the patient’s early life, such as an auto accident or the death of a loved one? All are common among patients with central pain, said Dr. Clauw, professor of anesthesiology and medicine (rheumatology) at the university.

Because these patients tend to have global sensory processing problems, asking about hypersensitivity to bright lights, odors, or noises will also help confirm the "central" diagnosis. Take a family history of pain as well, as there are strong familial and genetic linkages among the chronic pain syndromes, at least among women (Psychol. Med. 2009;39:497-505).

Physical examination is likely to be normal except for diffuse tenderness and nonspecific neurologic signs (Arthritis Rheum. 2009;60:2839-44). "This is why, historically, patients with fibromyalgia haven’t been believed," Dr. Clauw commented.

As for treatment, it is becoming increasingly clear that peripherally-acting pharmacologic agents such as opioids, corticosteroids, and nonsteroidal anti-inflammatory drugs simply do not work in central pain states.

Far more effective for fibromyalgia – and most likely other central pain states as well – are dual reuptake inhibitors such as tricyclic compounds (amitriptyline, cyclobenzaprine), serotonin-norepinephrine reuptake inhibitors (milnacipran, duloxetine), gamma hydroxybutyrate, and gabapentin. There is also modest evidence supporting the use of tramadol, selective serotonin reuptake inhibitors, and dopamine agonists (JAMA 2004;292:2388-95).

Nonpharmacologic therapies are also beneficial, including cognitive-behavioral therapy, exercise, and sleep hygiene (Best Pract. Res. Clin. Rheumatol. 2003;17:685-701).

Despite an abundance of emerging data to support the new way of thinking about chronic pain, Dr. Clauw said he thinks that shifting to a new management strategy could be difficult. "It takes a long time for people trained in one way of thinking to think differently. This isn’t just a new drug or a new device. This is a major paradigm shift."

Dr. Clauw disclosed that he is a consultant for Pfizer, Forest, Eli Lilly, Pierre Fabre Laboratories, Cypress Biosciences, Wyeth, UCB, AstraZeneca, Merck, Johnson & Johnson, Nuvo, and Jazz. He said he has also received research support from Pfizer, Cypress, and Forest.

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BETHESDA, Md. – When it comes to managing chronic pain, Dr. Daniel J. Clauw said physicians have been looking in the wrong places.

Dr. Daniel J. Clauw     

"There is no chronic pain state where degree of damage or inflammation in the periphery correlates well with level of pain. Yet, the diagnostic algorithms or paradigms that everyone uses for treating chronic pain still assume that all pain is nociceptive. What we see in the peripheral tissues is not necessarily what our patients are experiencing," said Dr. Clauw, director of the chronic pain and fatigue research center at the University of Michigan, Ann Arbor.

Historically, it has been assumed that when there was a disparity between peripheral findings and pain, psychological factors were at work. But the current view of chronic pain is that while it may originate from peripheral nociceptive input or nerve damage, central neuronal factors – at least some of them genetically determined – are nearly always playing a role in leading to interindividual differences in pain sensitivity, which are in turn closely associated with clinical outcomes.

For instance, population-based studies have shown that 30%-40% of individuals with radiographic evidence of severe damage from osteoarthritis are pain free, while 10% of those with normal radiographs have severe pain (Br. J. Rheumatol. 1997;36:726-8). Psychological factors explain very little of the variance between symptoms and structure (Arthritis Care Res. 1998;11:60-5), suggesting that central mechanisms involved in pain processing are at work, Dr. Clauw said at the workshop, sponsored by the University of Michigan and the National Institutes of Health.

Of course, individuals with osteoarthritis and rheumatoid arthritis will often have evidence of nociceptive input, while those with fibromyalgia have more prominent central factors. But no chronic pain state is solely due to any one of these mechanisms, he said.

"The scientific paradigm shift requires that we rethink everything from diagnostics and treatment approaches – which currently place an unjustified importance on treating peripheral factors," he said.

The new paradigm suggests that, regardless of the specific diagnosis, "central pain states" including fibromyalgia, rheumatoid arthritis, osteoarthritis, lupus, and low back pain all tend to share certain characteristics that can be better assessed by asking questions than by physical examination.

Showing patients a body diagram and asking them to label all the areas where they have pain is a simple assessment tool for multifocal pain. Also, ask about previous pain and other somatic symptoms such as fatigue, memory difficulty, mood disorders, and sleep disturbances, all common in the context of central pain but not with pain that is solely peripheral.

Is the pain triggered or exacerbated by stressors, such as psychological stress, infections, or physical trauma? Was there a salient stressor in the patient’s early life, such as an auto accident or the death of a loved one? All are common among patients with central pain, said Dr. Clauw, professor of anesthesiology and medicine (rheumatology) at the university.

Because these patients tend to have global sensory processing problems, asking about hypersensitivity to bright lights, odors, or noises will also help confirm the "central" diagnosis. Take a family history of pain as well, as there are strong familial and genetic linkages among the chronic pain syndromes, at least among women (Psychol. Med. 2009;39:497-505).

Physical examination is likely to be normal except for diffuse tenderness and nonspecific neurologic signs (Arthritis Rheum. 2009;60:2839-44). "This is why, historically, patients with fibromyalgia haven’t been believed," Dr. Clauw commented.

As for treatment, it is becoming increasingly clear that peripherally-acting pharmacologic agents such as opioids, corticosteroids, and nonsteroidal anti-inflammatory drugs simply do not work in central pain states.

Far more effective for fibromyalgia – and most likely other central pain states as well – are dual reuptake inhibitors such as tricyclic compounds (amitriptyline, cyclobenzaprine), serotonin-norepinephrine reuptake inhibitors (milnacipran, duloxetine), gamma hydroxybutyrate, and gabapentin. There is also modest evidence supporting the use of tramadol, selective serotonin reuptake inhibitors, and dopamine agonists (JAMA 2004;292:2388-95).

Nonpharmacologic therapies are also beneficial, including cognitive-behavioral therapy, exercise, and sleep hygiene (Best Pract. Res. Clin. Rheumatol. 2003;17:685-701).

Despite an abundance of emerging data to support the new way of thinking about chronic pain, Dr. Clauw said he thinks that shifting to a new management strategy could be difficult. "It takes a long time for people trained in one way of thinking to think differently. This isn’t just a new drug or a new device. This is a major paradigm shift."

Dr. Clauw disclosed that he is a consultant for Pfizer, Forest, Eli Lilly, Pierre Fabre Laboratories, Cypress Biosciences, Wyeth, UCB, AstraZeneca, Merck, Johnson & Johnson, Nuvo, and Jazz. He said he has also received research support from Pfizer, Cypress, and Forest.

BETHESDA, Md. – When it comes to managing chronic pain, Dr. Daniel J. Clauw said physicians have been looking in the wrong places.

Dr. Daniel J. Clauw     

"There is no chronic pain state where degree of damage or inflammation in the periphery correlates well with level of pain. Yet, the diagnostic algorithms or paradigms that everyone uses for treating chronic pain still assume that all pain is nociceptive. What we see in the peripheral tissues is not necessarily what our patients are experiencing," said Dr. Clauw, director of the chronic pain and fatigue research center at the University of Michigan, Ann Arbor.

Historically, it has been assumed that when there was a disparity between peripheral findings and pain, psychological factors were at work. But the current view of chronic pain is that while it may originate from peripheral nociceptive input or nerve damage, central neuronal factors – at least some of them genetically determined – are nearly always playing a role in leading to interindividual differences in pain sensitivity, which are in turn closely associated with clinical outcomes.

For instance, population-based studies have shown that 30%-40% of individuals with radiographic evidence of severe damage from osteoarthritis are pain free, while 10% of those with normal radiographs have severe pain (Br. J. Rheumatol. 1997;36:726-8). Psychological factors explain very little of the variance between symptoms and structure (Arthritis Care Res. 1998;11:60-5), suggesting that central mechanisms involved in pain processing are at work, Dr. Clauw said at the workshop, sponsored by the University of Michigan and the National Institutes of Health.

Of course, individuals with osteoarthritis and rheumatoid arthritis will often have evidence of nociceptive input, while those with fibromyalgia have more prominent central factors. But no chronic pain state is solely due to any one of these mechanisms, he said.

"The scientific paradigm shift requires that we rethink everything from diagnostics and treatment approaches – which currently place an unjustified importance on treating peripheral factors," he said.

The new paradigm suggests that, regardless of the specific diagnosis, "central pain states" including fibromyalgia, rheumatoid arthritis, osteoarthritis, lupus, and low back pain all tend to share certain characteristics that can be better assessed by asking questions than by physical examination.

Showing patients a body diagram and asking them to label all the areas where they have pain is a simple assessment tool for multifocal pain. Also, ask about previous pain and other somatic symptoms such as fatigue, memory difficulty, mood disorders, and sleep disturbances, all common in the context of central pain but not with pain that is solely peripheral.

Is the pain triggered or exacerbated by stressors, such as psychological stress, infections, or physical trauma? Was there a salient stressor in the patient’s early life, such as an auto accident or the death of a loved one? All are common among patients with central pain, said Dr. Clauw, professor of anesthesiology and medicine (rheumatology) at the university.

Because these patients tend to have global sensory processing problems, asking about hypersensitivity to bright lights, odors, or noises will also help confirm the "central" diagnosis. Take a family history of pain as well, as there are strong familial and genetic linkages among the chronic pain syndromes, at least among women (Psychol. Med. 2009;39:497-505).

Physical examination is likely to be normal except for diffuse tenderness and nonspecific neurologic signs (Arthritis Rheum. 2009;60:2839-44). "This is why, historically, patients with fibromyalgia haven’t been believed," Dr. Clauw commented.

As for treatment, it is becoming increasingly clear that peripherally-acting pharmacologic agents such as opioids, corticosteroids, and nonsteroidal anti-inflammatory drugs simply do not work in central pain states.

Far more effective for fibromyalgia – and most likely other central pain states as well – are dual reuptake inhibitors such as tricyclic compounds (amitriptyline, cyclobenzaprine), serotonin-norepinephrine reuptake inhibitors (milnacipran, duloxetine), gamma hydroxybutyrate, and gabapentin. There is also modest evidence supporting the use of tramadol, selective serotonin reuptake inhibitors, and dopamine agonists (JAMA 2004;292:2388-95).

Nonpharmacologic therapies are also beneficial, including cognitive-behavioral therapy, exercise, and sleep hygiene (Best Pract. Res. Clin. Rheumatol. 2003;17:685-701).

Despite an abundance of emerging data to support the new way of thinking about chronic pain, Dr. Clauw said he thinks that shifting to a new management strategy could be difficult. "It takes a long time for people trained in one way of thinking to think differently. This isn’t just a new drug or a new device. This is a major paradigm shift."

Dr. Clauw disclosed that he is a consultant for Pfizer, Forest, Eli Lilly, Pierre Fabre Laboratories, Cypress Biosciences, Wyeth, UCB, AstraZeneca, Merck, Johnson & Johnson, Nuvo, and Jazz. He said he has also received research support from Pfizer, Cypress, and Forest.

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Knee OA Symptoms, Metabolism Improved After Bariatric Surgery

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In obese patients with knee osteoarthritis, significant weight loss after bariatric surgery reduced pain and stiffness, decreased low-grade inflammation, and changed cartilage turnover, according to a study published in the January issue of Annals of Rheumatic Diseases.

In addition to the well-known relationship between obesity and onset of knee osteoarthritis (OA), several studies have now shown that the association goes beyond the increase in mechanical load on the tibiofemoral cartilage. "Adipose tissue may act as an endocrine organ, releasing several proinflammatory mediators and adipokines in blood that may participate in cartilage alteration in obese patients," according to Dr. Pascal Richette of Hôpital Lariboisière and coauthors. The authors added, "Trials that have assessed the efficacy of surgically induced massive weight loss on knee OA symptoms are scarce and have not specifically included patients with well-defined radiographic evidence of knee OA, as in our study." (Ann. Rheum. Dis. 2011;70:139-44).

The authors studied 44 obese patients (36 women) with a baseline body mass index of 50.7 before surgery and moderate to severe knee OA. The patients underwent laparoscopic Roux-en-Y gastric bypass surgery or laparoscopic adjustable gastric banding. Patient data was collected before and 6 months after the surgery.

At 6 months, patients had a 20% drop from baseline BMIs. Their VAS (visual acuity scores) decreased from 50 mm to 24.5 mm and their scores on the WOMAC (Western Ontario MacMaster) Questionnaire improved. Significant decreases were seen in average serum levels of interleukin-6 (IL-6), which declined by 26%, and of high-sensitivity C-reactive protein (hsCRP), which dropped 46%. Also, weight loss was associated with changes in adipokine levels: Mean serum leptin concentration was decreased by 48% and serum level of adiponectin was increased by 21%, the authors reported.

The average serum level of procollagen type II N-terminal propeptide (PIIANP), a marker of cartilage synthesis, rose 32%, while the serum level of cartilage oligomeric matrix protein (COMP) decreased by 36%. "These results are the first to suggest a benefit of weight loss on both cartilage anabolism and catabolism," the authors wrote.

The researchers found a significant correlation between IL-6 level and WOMAC Questionnaire scores as well as between urinary type II collagen helical peptide (helix-II) and hsCRP. Variation in COMP concentration was significantly correlated with changes in VAS pain scores and WOMAC stiffness score, the authors wrote, adding, "Our findings extend the results of recent work showing a significant association of IL-6 circulating levels and the prevalence and incidence of knee OA."

Since the study was an open exploratory study, it was prone to bias in evaluation of results. Also, the sample size was small. The findings don’t imply causality between variables, "and thus should be carefully interpreted," the researchers wrote. Also, "the effect of changes in insulin resistance related to weight loss on cartilage homoeostasis needs further investigation."

The study was funded by Assistance Publique-Hôpitaux de Paris, Direction of Clinical Research, which promoted and supported the clinical investigation, a grant from the European community, and the Association Rhumatisme et Travail (Hôpital Lariboisière, Paris).

The authors reported no financial conflicts of interest.

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In obese patients with knee osteoarthritis, significant weight loss after bariatric surgery reduced pain and stiffness, decreased low-grade inflammation, and changed cartilage turnover, according to a study published in the January issue of Annals of Rheumatic Diseases.

In addition to the well-known relationship between obesity and onset of knee osteoarthritis (OA), several studies have now shown that the association goes beyond the increase in mechanical load on the tibiofemoral cartilage. "Adipose tissue may act as an endocrine organ, releasing several proinflammatory mediators and adipokines in blood that may participate in cartilage alteration in obese patients," according to Dr. Pascal Richette of Hôpital Lariboisière and coauthors. The authors added, "Trials that have assessed the efficacy of surgically induced massive weight loss on knee OA symptoms are scarce and have not specifically included patients with well-defined radiographic evidence of knee OA, as in our study." (Ann. Rheum. Dis. 2011;70:139-44).

The authors studied 44 obese patients (36 women) with a baseline body mass index of 50.7 before surgery and moderate to severe knee OA. The patients underwent laparoscopic Roux-en-Y gastric bypass surgery or laparoscopic adjustable gastric banding. Patient data was collected before and 6 months after the surgery.

At 6 months, patients had a 20% drop from baseline BMIs. Their VAS (visual acuity scores) decreased from 50 mm to 24.5 mm and their scores on the WOMAC (Western Ontario MacMaster) Questionnaire improved. Significant decreases were seen in average serum levels of interleukin-6 (IL-6), which declined by 26%, and of high-sensitivity C-reactive protein (hsCRP), which dropped 46%. Also, weight loss was associated with changes in adipokine levels: Mean serum leptin concentration was decreased by 48% and serum level of adiponectin was increased by 21%, the authors reported.

The average serum level of procollagen type II N-terminal propeptide (PIIANP), a marker of cartilage synthesis, rose 32%, while the serum level of cartilage oligomeric matrix protein (COMP) decreased by 36%. "These results are the first to suggest a benefit of weight loss on both cartilage anabolism and catabolism," the authors wrote.

The researchers found a significant correlation between IL-6 level and WOMAC Questionnaire scores as well as between urinary type II collagen helical peptide (helix-II) and hsCRP. Variation in COMP concentration was significantly correlated with changes in VAS pain scores and WOMAC stiffness score, the authors wrote, adding, "Our findings extend the results of recent work showing a significant association of IL-6 circulating levels and the prevalence and incidence of knee OA."

Since the study was an open exploratory study, it was prone to bias in evaluation of results. Also, the sample size was small. The findings don’t imply causality between variables, "and thus should be carefully interpreted," the researchers wrote. Also, "the effect of changes in insulin resistance related to weight loss on cartilage homoeostasis needs further investigation."

The study was funded by Assistance Publique-Hôpitaux de Paris, Direction of Clinical Research, which promoted and supported the clinical investigation, a grant from the European community, and the Association Rhumatisme et Travail (Hôpital Lariboisière, Paris).

The authors reported no financial conflicts of interest.

In obese patients with knee osteoarthritis, significant weight loss after bariatric surgery reduced pain and stiffness, decreased low-grade inflammation, and changed cartilage turnover, according to a study published in the January issue of Annals of Rheumatic Diseases.

In addition to the well-known relationship between obesity and onset of knee osteoarthritis (OA), several studies have now shown that the association goes beyond the increase in mechanical load on the tibiofemoral cartilage. "Adipose tissue may act as an endocrine organ, releasing several proinflammatory mediators and adipokines in blood that may participate in cartilage alteration in obese patients," according to Dr. Pascal Richette of Hôpital Lariboisière and coauthors. The authors added, "Trials that have assessed the efficacy of surgically induced massive weight loss on knee OA symptoms are scarce and have not specifically included patients with well-defined radiographic evidence of knee OA, as in our study." (Ann. Rheum. Dis. 2011;70:139-44).

The authors studied 44 obese patients (36 women) with a baseline body mass index of 50.7 before surgery and moderate to severe knee OA. The patients underwent laparoscopic Roux-en-Y gastric bypass surgery or laparoscopic adjustable gastric banding. Patient data was collected before and 6 months after the surgery.

At 6 months, patients had a 20% drop from baseline BMIs. Their VAS (visual acuity scores) decreased from 50 mm to 24.5 mm and their scores on the WOMAC (Western Ontario MacMaster) Questionnaire improved. Significant decreases were seen in average serum levels of interleukin-6 (IL-6), which declined by 26%, and of high-sensitivity C-reactive protein (hsCRP), which dropped 46%. Also, weight loss was associated with changes in adipokine levels: Mean serum leptin concentration was decreased by 48% and serum level of adiponectin was increased by 21%, the authors reported.

The average serum level of procollagen type II N-terminal propeptide (PIIANP), a marker of cartilage synthesis, rose 32%, while the serum level of cartilage oligomeric matrix protein (COMP) decreased by 36%. "These results are the first to suggest a benefit of weight loss on both cartilage anabolism and catabolism," the authors wrote.

The researchers found a significant correlation between IL-6 level and WOMAC Questionnaire scores as well as between urinary type II collagen helical peptide (helix-II) and hsCRP. Variation in COMP concentration was significantly correlated with changes in VAS pain scores and WOMAC stiffness score, the authors wrote, adding, "Our findings extend the results of recent work showing a significant association of IL-6 circulating levels and the prevalence and incidence of knee OA."

Since the study was an open exploratory study, it was prone to bias in evaluation of results. Also, the sample size was small. The findings don’t imply causality between variables, "and thus should be carefully interpreted," the researchers wrote. Also, "the effect of changes in insulin resistance related to weight loss on cartilage homoeostasis needs further investigation."

The study was funded by Assistance Publique-Hôpitaux de Paris, Direction of Clinical Research, which promoted and supported the clinical investigation, a grant from the European community, and the Association Rhumatisme et Travail (Hôpital Lariboisière, Paris).

The authors reported no financial conflicts of interest.

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Major Finding: At 6 months after bariatric surgery, patients had a 20% drop from baseline BMI and their average serum level of procollagen type II N-terminal propeptide (PIIANP), a marker of cartilage synthesis, had risen 32%, while their average serum level of cartilage oligomeric matrix protein (COMP) had decreased by 36%.

Data Source: Baseline and 6-month follow-up measures in 36 women and 8 men who underwent bariatric surgery for obesity (average baseline BMI of 50.7) and had moderate to severe knee osteoarthritis.

Disclosures: The study was funded by Assistance Publique-Hôpitaux de Paris, Direction of Clinical Research, which promoted and supported the clinical investigation, a grant from the European community, and the Association Rhumatisme et Travail (Hôpital Lariboisière, Paris). The authors reported no financial conflicts of interest.

Digital X-Ray Radiogrammetry Shows Minute Bone Loss in RA

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Digital X-Ray Radiogrammetry Shows Minute Bone Loss in RA

Major Finding: Digital x-ray radiogrammetry detected small but significant bone loss in a group of postmenopausal women, compared with women receiving hormone therapy.

Data Source: A 2-year, single-blind, randomized controlled trial of 88 postmenopausal women with rheumatoid arthritis.

Disclosures: Dr. Forsblad-d'Elia and Dr. Carlsten said this study was supported by several grants from rheumatology and other foundations; they added that they had no competing interests to disclose.

Hormone therapy stabilized bone loss over a 2-year period in rheumatoid arthritis patients, as measured on digital x-ray radiogrammetry, a study has shown.

The study is important not only for finding that hormone therapy (HT) was effective, but because it depended on readings that detected losses of as little as 0.36%.

In contrast, plain radiographs, “the standard method for detection and quantification of joint destruction in RA,” cannot detect bone loss of less than 30%, wrote Dr. Helena Forsblad-d'Elia and Dr. Hans Carlsten (Ann. Rheum. Dis. 2010 Nov. 3 [doi: 10.1136/ard.2010.137133]).

Dr. Forsblad-d'Elia and Dr. Carlsten, both of the center for bone and arthritis research at the University of Gothenburg (Sweden), looked at 88 postmenopausal women with radiographic joint destruction due to rheumatoid arthritis. Findings from earlier research by Dr. Forsblad-d'Elia has shown that RA is strongly associated with generalized osteoporosis (Ann. Rheum. Dis. 2003;62:617-23).

Patients were randomized to one of two groups. The first received HT, which consisted of estradiol and norethisterone acetate, plus a daily dose of 500 mg calcium and 400 IU vitamin D. Controls received only the calcium and vitamin D.

Patients had digital x-ray radiogrammetry–bone mineral density (DXR-BMD) readings at baseline and at 2 years. A total of 50 women (23 HT patients, 27 controls) were ultimately included in the study analysis. The mean age of both groups was roughly 58 years, and both groups had a mean disease duration of greater than 10 years.

According to the researchers, at baseline, HT patients and controls had an identical mean DXR-BMD reading of 0.45 g/cm

Two years later, HT patients' mean reading was identical except for a tiny increase in the standard deviation, to 0.097, whereas control patients' mean DXR-BMD was 0.44, with a standard deviation of 0.084. The minute difference was insignificant for the HT group, but significant for controls, both in terms of change from baseline and difference from the HT group. Put another way, the decrease among HT patients from baseline was 0.36%, while the decrease from baseline for controls was 3.74% – more than 10 times greater.

“DXR-BMD has been proposed to be an outcome measure in monitoring treatments in early RA, and can predict future radiographic joint damage,” concluded the authors. Based on the current data, however, “we suggest that DXR-BMD could serve as an outcome measure in [randomized controlled trials] in long-standing RA,” they wrote.

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Major Finding: Digital x-ray radiogrammetry detected small but significant bone loss in a group of postmenopausal women, compared with women receiving hormone therapy.

Data Source: A 2-year, single-blind, randomized controlled trial of 88 postmenopausal women with rheumatoid arthritis.

Disclosures: Dr. Forsblad-d'Elia and Dr. Carlsten said this study was supported by several grants from rheumatology and other foundations; they added that they had no competing interests to disclose.

Hormone therapy stabilized bone loss over a 2-year period in rheumatoid arthritis patients, as measured on digital x-ray radiogrammetry, a study has shown.

The study is important not only for finding that hormone therapy (HT) was effective, but because it depended on readings that detected losses of as little as 0.36%.

In contrast, plain radiographs, “the standard method for detection and quantification of joint destruction in RA,” cannot detect bone loss of less than 30%, wrote Dr. Helena Forsblad-d'Elia and Dr. Hans Carlsten (Ann. Rheum. Dis. 2010 Nov. 3 [doi: 10.1136/ard.2010.137133]).

Dr. Forsblad-d'Elia and Dr. Carlsten, both of the center for bone and arthritis research at the University of Gothenburg (Sweden), looked at 88 postmenopausal women with radiographic joint destruction due to rheumatoid arthritis. Findings from earlier research by Dr. Forsblad-d'Elia has shown that RA is strongly associated with generalized osteoporosis (Ann. Rheum. Dis. 2003;62:617-23).

Patients were randomized to one of two groups. The first received HT, which consisted of estradiol and norethisterone acetate, plus a daily dose of 500 mg calcium and 400 IU vitamin D. Controls received only the calcium and vitamin D.

Patients had digital x-ray radiogrammetry–bone mineral density (DXR-BMD) readings at baseline and at 2 years. A total of 50 women (23 HT patients, 27 controls) were ultimately included in the study analysis. The mean age of both groups was roughly 58 years, and both groups had a mean disease duration of greater than 10 years.

According to the researchers, at baseline, HT patients and controls had an identical mean DXR-BMD reading of 0.45 g/cm

Two years later, HT patients' mean reading was identical except for a tiny increase in the standard deviation, to 0.097, whereas control patients' mean DXR-BMD was 0.44, with a standard deviation of 0.084. The minute difference was insignificant for the HT group, but significant for controls, both in terms of change from baseline and difference from the HT group. Put another way, the decrease among HT patients from baseline was 0.36%, while the decrease from baseline for controls was 3.74% – more than 10 times greater.

“DXR-BMD has been proposed to be an outcome measure in monitoring treatments in early RA, and can predict future radiographic joint damage,” concluded the authors. Based on the current data, however, “we suggest that DXR-BMD could serve as an outcome measure in [randomized controlled trials] in long-standing RA,” they wrote.

Major Finding: Digital x-ray radiogrammetry detected small but significant bone loss in a group of postmenopausal women, compared with women receiving hormone therapy.

Data Source: A 2-year, single-blind, randomized controlled trial of 88 postmenopausal women with rheumatoid arthritis.

Disclosures: Dr. Forsblad-d'Elia and Dr. Carlsten said this study was supported by several grants from rheumatology and other foundations; they added that they had no competing interests to disclose.

Hormone therapy stabilized bone loss over a 2-year period in rheumatoid arthritis patients, as measured on digital x-ray radiogrammetry, a study has shown.

The study is important not only for finding that hormone therapy (HT) was effective, but because it depended on readings that detected losses of as little as 0.36%.

In contrast, plain radiographs, “the standard method for detection and quantification of joint destruction in RA,” cannot detect bone loss of less than 30%, wrote Dr. Helena Forsblad-d'Elia and Dr. Hans Carlsten (Ann. Rheum. Dis. 2010 Nov. 3 [doi: 10.1136/ard.2010.137133]).

Dr. Forsblad-d'Elia and Dr. Carlsten, both of the center for bone and arthritis research at the University of Gothenburg (Sweden), looked at 88 postmenopausal women with radiographic joint destruction due to rheumatoid arthritis. Findings from earlier research by Dr. Forsblad-d'Elia has shown that RA is strongly associated with generalized osteoporosis (Ann. Rheum. Dis. 2003;62:617-23).

Patients were randomized to one of two groups. The first received HT, which consisted of estradiol and norethisterone acetate, plus a daily dose of 500 mg calcium and 400 IU vitamin D. Controls received only the calcium and vitamin D.

Patients had digital x-ray radiogrammetry–bone mineral density (DXR-BMD) readings at baseline and at 2 years. A total of 50 women (23 HT patients, 27 controls) were ultimately included in the study analysis. The mean age of both groups was roughly 58 years, and both groups had a mean disease duration of greater than 10 years.

According to the researchers, at baseline, HT patients and controls had an identical mean DXR-BMD reading of 0.45 g/cm

Two years later, HT patients' mean reading was identical except for a tiny increase in the standard deviation, to 0.097, whereas control patients' mean DXR-BMD was 0.44, with a standard deviation of 0.084. The minute difference was insignificant for the HT group, but significant for controls, both in terms of change from baseline and difference from the HT group. Put another way, the decrease among HT patients from baseline was 0.36%, while the decrease from baseline for controls was 3.74% – more than 10 times greater.

“DXR-BMD has been proposed to be an outcome measure in monitoring treatments in early RA, and can predict future radiographic joint damage,” concluded the authors. Based on the current data, however, “we suggest that DXR-BMD could serve as an outcome measure in [randomized controlled trials] in long-standing RA,” they wrote.

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Program Improves Hip Fracture Outcomes : Targeted intervention that includes progressive resistance training lowered mortality, dependency.

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Program Improves Hip Fracture Outcomes : Targeted intervention that includes progressive resistance training lowered mortality, dependency.

Major Finding: Age-adjusted risk of death was significantly reduced in the intervention group, compared with usual care (odds ratio = 0.19).

Data Source: The Hip Fracture Intervention Trial (HIPFIT) compared outcomes for 62 hip fracture patients randomized to resistance training and up to 12 other interventions versus 62 randomized to usual care (6-12 weeks of physiotherapy, an orthopedic consult at 6 weeks, and any recommended therapies).

Disclosures: Dr. Singh said she had no relevant financial disclosures.

NEW ORLEANS — Compared with usual care after hip fracture, a comprehensive and targeted intervention that includes high-intensity progressive resistance training over 12 months lowers mortality, decreases nursing home admissions, improves activities of daily living dependency, and decreases the use of assistive devices, according to a randomized, controlled trial.

“It is possible to change the most important outcomes for these people,” Dr. Maria A. Fiatarone Singh said.

Functional dependency, however, did not significantly differ between groups.

Many facets of hip fractures have been studied, from pharmacologic prevention of osteoporosis to acute hospital interventions to fracture rehabilitation. “Although we've done a lot of studies, we still have not figured out how to prevent people from entering a nursing home or dying,” said Dr. Singh, professor of medicine and chair of exercise and sport science at the University of Sydney.

So Dr. Singh and her colleagues launched the Hip Fracture Intervention Trial (HIPFIT). They compared outcomes for 62 hip fracture patients randomized to resistance training and up to 12 other interventions vs. 62 patients randomized to usual care. Intervention was associated with an 84% reduction in the likelihood of nursing home admission (odds ratio, 0.16), compared with usual care, Dr. Singh said. In absolute numbers, 5 intervention patients (8%) and 12 control patients (19%) were admitted to a nursing home during the 12 months of follow-up.

“Hip fracture is associated with chronic pain, reduced mobility, disability, and increasing degree of dependence. After hip fracture, 10%-20% of formerly community-dwelling people require long-term nursing home care,” Dr. Singh said.

Four intervention patients and eight usual-care patients died. Age-adjusted risk of death was significantly reduced in the intervention group, compared with usual care (OR = 0.19). Cardiovascular disease, infection, and stroke were among the causes.

Dr. Singh and her associates hypothesized that long-term disability and nursing home utilization after hip fracture would be reduced by targeted, multifactorial intervention aimed at the primary risk factors. They chose modifiable risk factors to make application of their findings more practical, including sarcopenia/muscle weakness, poor balance or gait, malnutrition or weight loss, vitamin D insufficiency, and vision concerns.

All intervention group participants received hip protectors and supervised, high-intensity, progressive resistance training for 12 months. The protocol included seven exercises designed for both upper and lower body strength. A meeting attendee questioned how patients were able to exercise after hip fracture. The intervention began with an isometric measure of strength and actual strength training started about 6 months after fracture, Dr. Singh replied.

Balance training exercises were progressive as well. As tasks were mastered, participants graduated to a more difficult level. For example, if a person could balance holding on to something with two hands, next they progressed to one hand and then to one finger.

Interventions were added for individual participants as needed, up to a total of 13. Treatment of depression, nutritional supplementation, medication management, and vision assessment are examples. Some participants received home assessment and referral to community services. Others received interventions to address risk and/or fear of falling, low self-efficacy, and polypharmacy.

Evaluations were done at baseline and at 4 and 12 months after fracture, with regular review by geriatricians, general practitioners, and ophthalmologists.

A meeting attendee asked which interventions were most useful. “Our specific intent was not to break apart the 13 interventions,” Dr. Singh said. She said many were intertwined, for example, vision improvements allowed balance training to be more effective. The effects of strength and balance training were most robust because they were performed twice a week for 12 months.

Usual care included 6-12 weeks of physiotherapy, an orthopedic consult at 6 weeks, and any recommended therapies. “We sent letter to general practitioners if people [in the usual-care group] were depressed, had low vitamin D, or abnormal cognitive function. We did not prescribe for this group,” she said.

Even though overall functional dependency did not differ significantly, intervention was associated with significantly less decline in some functional dependency KATZ scores (total, continence, and transfer) at 12 months, compared with their prefracture baseline. This is relevant, Dr. Singh said, because previous research they did showed that overall function declines for most people after a hip fracture. Only 20% of participants in the Sarcopenia and Hip Fracture Study (SHIP) returned to baseline function at 12 months (J. Gerontol. A. Biol. Sci. Med. Sci. 2009;64:568-74). In the current study, after the researchers controlled for age, there was less of a decline in function for total KATZ score, transfer change, and continence change if patients were in intervention group vs. usual care, according to Dr. Singh.

 

 

“Did changes in KATZ activities of daily living total score and scales mediate the nursing home admissions we saw? It seemed to be the case,” Dr. Singh said. “The nursing home residents had greater decline in KATZ function and toileting [continence] scores vs. others.”

All results are based on an intent-to-treat analysis. The dropout rate was low, she said: nine HIPFIT patients and three usual-care patients did not complete follow-up.

At baseline, the community-dwelling participants were 69% female; mean age, 79 years; 83% at nutritional risk; 88% vitamin D insufficient; 90% living independently (vs. 10% in nursing homes); and 38% were cognitively impaired. A total 45% were depressed. The mean number of chronic diseases was 3.4. The usual-care group reported worse bodily pain, the only significant difference between groups. There were no adverse events, except for some musculoskeletal soreness after activity.

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Major Finding: Age-adjusted risk of death was significantly reduced in the intervention group, compared with usual care (odds ratio = 0.19).

Data Source: The Hip Fracture Intervention Trial (HIPFIT) compared outcomes for 62 hip fracture patients randomized to resistance training and up to 12 other interventions versus 62 randomized to usual care (6-12 weeks of physiotherapy, an orthopedic consult at 6 weeks, and any recommended therapies).

Disclosures: Dr. Singh said she had no relevant financial disclosures.

NEW ORLEANS — Compared with usual care after hip fracture, a comprehensive and targeted intervention that includes high-intensity progressive resistance training over 12 months lowers mortality, decreases nursing home admissions, improves activities of daily living dependency, and decreases the use of assistive devices, according to a randomized, controlled trial.

“It is possible to change the most important outcomes for these people,” Dr. Maria A. Fiatarone Singh said.

Functional dependency, however, did not significantly differ between groups.

Many facets of hip fractures have been studied, from pharmacologic prevention of osteoporosis to acute hospital interventions to fracture rehabilitation. “Although we've done a lot of studies, we still have not figured out how to prevent people from entering a nursing home or dying,” said Dr. Singh, professor of medicine and chair of exercise and sport science at the University of Sydney.

So Dr. Singh and her colleagues launched the Hip Fracture Intervention Trial (HIPFIT). They compared outcomes for 62 hip fracture patients randomized to resistance training and up to 12 other interventions vs. 62 patients randomized to usual care. Intervention was associated with an 84% reduction in the likelihood of nursing home admission (odds ratio, 0.16), compared with usual care, Dr. Singh said. In absolute numbers, 5 intervention patients (8%) and 12 control patients (19%) were admitted to a nursing home during the 12 months of follow-up.

“Hip fracture is associated with chronic pain, reduced mobility, disability, and increasing degree of dependence. After hip fracture, 10%-20% of formerly community-dwelling people require long-term nursing home care,” Dr. Singh said.

Four intervention patients and eight usual-care patients died. Age-adjusted risk of death was significantly reduced in the intervention group, compared with usual care (OR = 0.19). Cardiovascular disease, infection, and stroke were among the causes.

Dr. Singh and her associates hypothesized that long-term disability and nursing home utilization after hip fracture would be reduced by targeted, multifactorial intervention aimed at the primary risk factors. They chose modifiable risk factors to make application of their findings more practical, including sarcopenia/muscle weakness, poor balance or gait, malnutrition or weight loss, vitamin D insufficiency, and vision concerns.

All intervention group participants received hip protectors and supervised, high-intensity, progressive resistance training for 12 months. The protocol included seven exercises designed for both upper and lower body strength. A meeting attendee questioned how patients were able to exercise after hip fracture. The intervention began with an isometric measure of strength and actual strength training started about 6 months after fracture, Dr. Singh replied.

Balance training exercises were progressive as well. As tasks were mastered, participants graduated to a more difficult level. For example, if a person could balance holding on to something with two hands, next they progressed to one hand and then to one finger.

Interventions were added for individual participants as needed, up to a total of 13. Treatment of depression, nutritional supplementation, medication management, and vision assessment are examples. Some participants received home assessment and referral to community services. Others received interventions to address risk and/or fear of falling, low self-efficacy, and polypharmacy.

Evaluations were done at baseline and at 4 and 12 months after fracture, with regular review by geriatricians, general practitioners, and ophthalmologists.

A meeting attendee asked which interventions were most useful. “Our specific intent was not to break apart the 13 interventions,” Dr. Singh said. She said many were intertwined, for example, vision improvements allowed balance training to be more effective. The effects of strength and balance training were most robust because they were performed twice a week for 12 months.

Usual care included 6-12 weeks of physiotherapy, an orthopedic consult at 6 weeks, and any recommended therapies. “We sent letter to general practitioners if people [in the usual-care group] were depressed, had low vitamin D, or abnormal cognitive function. We did not prescribe for this group,” she said.

Even though overall functional dependency did not differ significantly, intervention was associated with significantly less decline in some functional dependency KATZ scores (total, continence, and transfer) at 12 months, compared with their prefracture baseline. This is relevant, Dr. Singh said, because previous research they did showed that overall function declines for most people after a hip fracture. Only 20% of participants in the Sarcopenia and Hip Fracture Study (SHIP) returned to baseline function at 12 months (J. Gerontol. A. Biol. Sci. Med. Sci. 2009;64:568-74). In the current study, after the researchers controlled for age, there was less of a decline in function for total KATZ score, transfer change, and continence change if patients were in intervention group vs. usual care, according to Dr. Singh.

 

 

“Did changes in KATZ activities of daily living total score and scales mediate the nursing home admissions we saw? It seemed to be the case,” Dr. Singh said. “The nursing home residents had greater decline in KATZ function and toileting [continence] scores vs. others.”

All results are based on an intent-to-treat analysis. The dropout rate was low, she said: nine HIPFIT patients and three usual-care patients did not complete follow-up.

At baseline, the community-dwelling participants were 69% female; mean age, 79 years; 83% at nutritional risk; 88% vitamin D insufficient; 90% living independently (vs. 10% in nursing homes); and 38% were cognitively impaired. A total 45% were depressed. The mean number of chronic diseases was 3.4. The usual-care group reported worse bodily pain, the only significant difference between groups. There were no adverse events, except for some musculoskeletal soreness after activity.

Major Finding: Age-adjusted risk of death was significantly reduced in the intervention group, compared with usual care (odds ratio = 0.19).

Data Source: The Hip Fracture Intervention Trial (HIPFIT) compared outcomes for 62 hip fracture patients randomized to resistance training and up to 12 other interventions versus 62 randomized to usual care (6-12 weeks of physiotherapy, an orthopedic consult at 6 weeks, and any recommended therapies).

Disclosures: Dr. Singh said she had no relevant financial disclosures.

NEW ORLEANS — Compared with usual care after hip fracture, a comprehensive and targeted intervention that includes high-intensity progressive resistance training over 12 months lowers mortality, decreases nursing home admissions, improves activities of daily living dependency, and decreases the use of assistive devices, according to a randomized, controlled trial.

“It is possible to change the most important outcomes for these people,” Dr. Maria A. Fiatarone Singh said.

Functional dependency, however, did not significantly differ between groups.

Many facets of hip fractures have been studied, from pharmacologic prevention of osteoporosis to acute hospital interventions to fracture rehabilitation. “Although we've done a lot of studies, we still have not figured out how to prevent people from entering a nursing home or dying,” said Dr. Singh, professor of medicine and chair of exercise and sport science at the University of Sydney.

So Dr. Singh and her colleagues launched the Hip Fracture Intervention Trial (HIPFIT). They compared outcomes for 62 hip fracture patients randomized to resistance training and up to 12 other interventions vs. 62 patients randomized to usual care. Intervention was associated with an 84% reduction in the likelihood of nursing home admission (odds ratio, 0.16), compared with usual care, Dr. Singh said. In absolute numbers, 5 intervention patients (8%) and 12 control patients (19%) were admitted to a nursing home during the 12 months of follow-up.

“Hip fracture is associated with chronic pain, reduced mobility, disability, and increasing degree of dependence. After hip fracture, 10%-20% of formerly community-dwelling people require long-term nursing home care,” Dr. Singh said.

Four intervention patients and eight usual-care patients died. Age-adjusted risk of death was significantly reduced in the intervention group, compared with usual care (OR = 0.19). Cardiovascular disease, infection, and stroke were among the causes.

Dr. Singh and her associates hypothesized that long-term disability and nursing home utilization after hip fracture would be reduced by targeted, multifactorial intervention aimed at the primary risk factors. They chose modifiable risk factors to make application of their findings more practical, including sarcopenia/muscle weakness, poor balance or gait, malnutrition or weight loss, vitamin D insufficiency, and vision concerns.

All intervention group participants received hip protectors and supervised, high-intensity, progressive resistance training for 12 months. The protocol included seven exercises designed for both upper and lower body strength. A meeting attendee questioned how patients were able to exercise after hip fracture. The intervention began with an isometric measure of strength and actual strength training started about 6 months after fracture, Dr. Singh replied.

Balance training exercises were progressive as well. As tasks were mastered, participants graduated to a more difficult level. For example, if a person could balance holding on to something with two hands, next they progressed to one hand and then to one finger.

Interventions were added for individual participants as needed, up to a total of 13. Treatment of depression, nutritional supplementation, medication management, and vision assessment are examples. Some participants received home assessment and referral to community services. Others received interventions to address risk and/or fear of falling, low self-efficacy, and polypharmacy.

Evaluations were done at baseline and at 4 and 12 months after fracture, with regular review by geriatricians, general practitioners, and ophthalmologists.

A meeting attendee asked which interventions were most useful. “Our specific intent was not to break apart the 13 interventions,” Dr. Singh said. She said many were intertwined, for example, vision improvements allowed balance training to be more effective. The effects of strength and balance training were most robust because they were performed twice a week for 12 months.

Usual care included 6-12 weeks of physiotherapy, an orthopedic consult at 6 weeks, and any recommended therapies. “We sent letter to general practitioners if people [in the usual-care group] were depressed, had low vitamin D, or abnormal cognitive function. We did not prescribe for this group,” she said.

Even though overall functional dependency did not differ significantly, intervention was associated with significantly less decline in some functional dependency KATZ scores (total, continence, and transfer) at 12 months, compared with their prefracture baseline. This is relevant, Dr. Singh said, because previous research they did showed that overall function declines for most people after a hip fracture. Only 20% of participants in the Sarcopenia and Hip Fracture Study (SHIP) returned to baseline function at 12 months (J. Gerontol. A. Biol. Sci. Med. Sci. 2009;64:568-74). In the current study, after the researchers controlled for age, there was less of a decline in function for total KATZ score, transfer change, and continence change if patients were in intervention group vs. usual care, according to Dr. Singh.

 

 

“Did changes in KATZ activities of daily living total score and scales mediate the nursing home admissions we saw? It seemed to be the case,” Dr. Singh said. “The nursing home residents had greater decline in KATZ function and toileting [continence] scores vs. others.”

All results are based on an intent-to-treat analysis. The dropout rate was low, she said: nine HIPFIT patients and three usual-care patients did not complete follow-up.

At baseline, the community-dwelling participants were 69% female; mean age, 79 years; 83% at nutritional risk; 88% vitamin D insufficient; 90% living independently (vs. 10% in nursing homes); and 38% were cognitively impaired. A total 45% were depressed. The mean number of chronic diseases was 3.4. The usual-care group reported worse bodily pain, the only significant difference between groups. There were no adverse events, except for some musculoskeletal soreness after activity.

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Short-Acting Opioids Up Fracture Risk in Arthritic Elderly

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 DENVER – Elderly patients who are placed on a short-acting opioid analgesic for treatment of arthritis pain are twice as likely to experience a fracture during the subsequent year, compared with those on a long-acting opioid, according to a large cohort study.

The increased fracture risk was particularly strong during the first 2 weeks after initiation of therapy, when the relative risk was almost sevenfold higher in patients on a short-acting opioid, such as propoxyphene or oxycodone, than in those who were started on an NSAID or long-acting opioid, including fentanyl or sustained-release hydrocodone. After that initial 2-week period, the fracture risk dropped off but remained about threefold greater than with NSAID therapy, Dr. Matthew Miller reported at the meeting.

The fracture risk during the first 2 weeks on a long-acting opioid didn't differ significantly from that in patients on an NSAID. Over the course of 1 year, however, the difference grew such that the cumulative fracture risk was 2.6-fold greater in the group on a long-acting opioid than in those on an NSAID.

In contrast, the relative risk of fracture at 1 year was increased 5.1-fold in elderly arthritis patients on a short-acting opioid, added Dr. Miller of the Harvard Injury Control Research Center, Boston.

“Our findings … suggest that clinicians should be alert to the possibility that short-acting opioids pose a significantly greater risk of fractures among older adults than do equianalgesic doses of long-acting opioids, especially during the first 2 weeks after initiating therapy,” he observed. These results have the potential to change clinical practice by shifting prescribing in the direction of greater use of long-acting opioids in the elderly. At present, short-acting opioids are prescribed far more often than long-acting ones.

His study involved 12,436 Medicare beneficiaries with arthritis who initiated monotherapy with an opioid analgesic, and 4,874 who started on an NSAID. Participants averaged 81 years of age, and 85% were women. Osteoarthritis was the diagnosis in 90%; the rest had rheumatoid arthritis. None of the subjects had been on an opioid within the previous 6 months. Not surprisingly, patients who were started on an opioid tended to be somewhat sicker, with a mean baseline Charlson comorbidity index score of 2.2 in the short-acting opioid group, 2.1 in those on a long-acting opioid, and 1.6 in the NSAID group.

The primary study end point was the 1-year incidence of fractures of the hip, radius, ulna, or wrist. The incidence rate was 25 fractures per 1,000 person-years in the NSAID group, 128 per 1,000 person-years in those on short-acting opioids, and 53 per 1,000 person-years in the group on long-acting opioids.

A dose effect was evident. Patients on a low-dose opioid had a 2.2-fold greater fracture risk than did those on an NSAID, after adjustment for comorbid conditions and other potential confounding variables. Patients on a moderate-dose opioid had a 4.6-fold increased risk. And those on high-dose opioid therapy had a 5.1-fold increased risk.

Asked why he thought short-acting opioids were prescribed 13 times more frequently than long-acting ones in the study population, Dr. Miller replied that although the study didn't address this question, it's his impression that many physicians believe that if they place a patient on a long-acting opioid, the patient may not get pain relief quickly enough. Hence, the patient might take another dose, and then another, perhaps getting into the overdose range. This belief about long-acting opioids' sluggish onset of action, he added, is erroneous.

“It's important to recognize that the modern formulations of these long-acting drugs can actually provide adequate analgesia in a time scale that's similar to that for short-acting drugs, because of the long-acting agents' biphasic distribution in the blood stream,” Dr. Miller said.

The Food and Drug Administration recently removed from the U.S. market one of the short-acting opioids in this study – propoxyphene – because of an increased risk for fatal heart rhythm abnormalities associated with its use.

Dr. Miller declared having no relevant financial interests.

Long-acting opioids provide adequate relief in a time scale that's similar to that for short-acting drugs.

Source DR. MILLER

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 DENVER – Elderly patients who are placed on a short-acting opioid analgesic for treatment of arthritis pain are twice as likely to experience a fracture during the subsequent year, compared with those on a long-acting opioid, according to a large cohort study.

The increased fracture risk was particularly strong during the first 2 weeks after initiation of therapy, when the relative risk was almost sevenfold higher in patients on a short-acting opioid, such as propoxyphene or oxycodone, than in those who were started on an NSAID or long-acting opioid, including fentanyl or sustained-release hydrocodone. After that initial 2-week period, the fracture risk dropped off but remained about threefold greater than with NSAID therapy, Dr. Matthew Miller reported at the meeting.

The fracture risk during the first 2 weeks on a long-acting opioid didn't differ significantly from that in patients on an NSAID. Over the course of 1 year, however, the difference grew such that the cumulative fracture risk was 2.6-fold greater in the group on a long-acting opioid than in those on an NSAID.

In contrast, the relative risk of fracture at 1 year was increased 5.1-fold in elderly arthritis patients on a short-acting opioid, added Dr. Miller of the Harvard Injury Control Research Center, Boston.

“Our findings … suggest that clinicians should be alert to the possibility that short-acting opioids pose a significantly greater risk of fractures among older adults than do equianalgesic doses of long-acting opioids, especially during the first 2 weeks after initiating therapy,” he observed. These results have the potential to change clinical practice by shifting prescribing in the direction of greater use of long-acting opioids in the elderly. At present, short-acting opioids are prescribed far more often than long-acting ones.

His study involved 12,436 Medicare beneficiaries with arthritis who initiated monotherapy with an opioid analgesic, and 4,874 who started on an NSAID. Participants averaged 81 years of age, and 85% were women. Osteoarthritis was the diagnosis in 90%; the rest had rheumatoid arthritis. None of the subjects had been on an opioid within the previous 6 months. Not surprisingly, patients who were started on an opioid tended to be somewhat sicker, with a mean baseline Charlson comorbidity index score of 2.2 in the short-acting opioid group, 2.1 in those on a long-acting opioid, and 1.6 in the NSAID group.

The primary study end point was the 1-year incidence of fractures of the hip, radius, ulna, or wrist. The incidence rate was 25 fractures per 1,000 person-years in the NSAID group, 128 per 1,000 person-years in those on short-acting opioids, and 53 per 1,000 person-years in the group on long-acting opioids.

A dose effect was evident. Patients on a low-dose opioid had a 2.2-fold greater fracture risk than did those on an NSAID, after adjustment for comorbid conditions and other potential confounding variables. Patients on a moderate-dose opioid had a 4.6-fold increased risk. And those on high-dose opioid therapy had a 5.1-fold increased risk.

Asked why he thought short-acting opioids were prescribed 13 times more frequently than long-acting ones in the study population, Dr. Miller replied that although the study didn't address this question, it's his impression that many physicians believe that if they place a patient on a long-acting opioid, the patient may not get pain relief quickly enough. Hence, the patient might take another dose, and then another, perhaps getting into the overdose range. This belief about long-acting opioids' sluggish onset of action, he added, is erroneous.

“It's important to recognize that the modern formulations of these long-acting drugs can actually provide adequate analgesia in a time scale that's similar to that for short-acting drugs, because of the long-acting agents' biphasic distribution in the blood stream,” Dr. Miller said.

The Food and Drug Administration recently removed from the U.S. market one of the short-acting opioids in this study – propoxyphene – because of an increased risk for fatal heart rhythm abnormalities associated with its use.

Dr. Miller declared having no relevant financial interests.

Long-acting opioids provide adequate relief in a time scale that's similar to that for short-acting drugs.

Source DR. MILLER

 DENVER – Elderly patients who are placed on a short-acting opioid analgesic for treatment of arthritis pain are twice as likely to experience a fracture during the subsequent year, compared with those on a long-acting opioid, according to a large cohort study.

The increased fracture risk was particularly strong during the first 2 weeks after initiation of therapy, when the relative risk was almost sevenfold higher in patients on a short-acting opioid, such as propoxyphene or oxycodone, than in those who were started on an NSAID or long-acting opioid, including fentanyl or sustained-release hydrocodone. After that initial 2-week period, the fracture risk dropped off but remained about threefold greater than with NSAID therapy, Dr. Matthew Miller reported at the meeting.

The fracture risk during the first 2 weeks on a long-acting opioid didn't differ significantly from that in patients on an NSAID. Over the course of 1 year, however, the difference grew such that the cumulative fracture risk was 2.6-fold greater in the group on a long-acting opioid than in those on an NSAID.

In contrast, the relative risk of fracture at 1 year was increased 5.1-fold in elderly arthritis patients on a short-acting opioid, added Dr. Miller of the Harvard Injury Control Research Center, Boston.

“Our findings … suggest that clinicians should be alert to the possibility that short-acting opioids pose a significantly greater risk of fractures among older adults than do equianalgesic doses of long-acting opioids, especially during the first 2 weeks after initiating therapy,” he observed. These results have the potential to change clinical practice by shifting prescribing in the direction of greater use of long-acting opioids in the elderly. At present, short-acting opioids are prescribed far more often than long-acting ones.

His study involved 12,436 Medicare beneficiaries with arthritis who initiated monotherapy with an opioid analgesic, and 4,874 who started on an NSAID. Participants averaged 81 years of age, and 85% were women. Osteoarthritis was the diagnosis in 90%; the rest had rheumatoid arthritis. None of the subjects had been on an opioid within the previous 6 months. Not surprisingly, patients who were started on an opioid tended to be somewhat sicker, with a mean baseline Charlson comorbidity index score of 2.2 in the short-acting opioid group, 2.1 in those on a long-acting opioid, and 1.6 in the NSAID group.

The primary study end point was the 1-year incidence of fractures of the hip, radius, ulna, or wrist. The incidence rate was 25 fractures per 1,000 person-years in the NSAID group, 128 per 1,000 person-years in those on short-acting opioids, and 53 per 1,000 person-years in the group on long-acting opioids.

A dose effect was evident. Patients on a low-dose opioid had a 2.2-fold greater fracture risk than did those on an NSAID, after adjustment for comorbid conditions and other potential confounding variables. Patients on a moderate-dose opioid had a 4.6-fold increased risk. And those on high-dose opioid therapy had a 5.1-fold increased risk.

Asked why he thought short-acting opioids were prescribed 13 times more frequently than long-acting ones in the study population, Dr. Miller replied that although the study didn't address this question, it's his impression that many physicians believe that if they place a patient on a long-acting opioid, the patient may not get pain relief quickly enough. Hence, the patient might take another dose, and then another, perhaps getting into the overdose range. This belief about long-acting opioids' sluggish onset of action, he added, is erroneous.

“It's important to recognize that the modern formulations of these long-acting drugs can actually provide adequate analgesia in a time scale that's similar to that for short-acting drugs, because of the long-acting agents' biphasic distribution in the blood stream,” Dr. Miller said.

The Food and Drug Administration recently removed from the U.S. market one of the short-acting opioids in this study – propoxyphene – because of an increased risk for fatal heart rhythm abnormalities associated with its use.

Dr. Miller declared having no relevant financial interests.

Long-acting opioids provide adequate relief in a time scale that's similar to that for short-acting drugs.

Source DR. MILLER

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Opioids Riskier Than Other Agents in Elderly

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Opioids were associated with more risks than were other analgesics in elderly patients taking the drugs for arthritis pain, according to a report in the Archives of Internal Medicine.

Although NSAIDs are known to pose certain risks, the results of the study “support the safety of [NSAIDs] compared with other analgesics,” said Dr. Daniel H. Solomon and his associates at Brigham and Women's Hospital, Boston.

Few studies have examined the relative risks of the three major analgesic groups: NSAIDs, opioids, and coxibs (selective cyclooxygenase-2 inhibitors). “Postmarketing surveillance data from usual care cohorts provide an opportunity to examine comparative safety across a wide range of events and can complement safety data from randomized controlled trials. However, imbalance in baseline population characteristics confounds many postmarketing surveillance studies,” Dr. Solomon and his colleagues noted (Arch. Intern. Med. 2010;170:1968-78). “Propensity score-matched analyses may provide better balance of confounders and facilitate relatively straightforward comparative safety analyses,” they added.

To compare safety, the researchers performed a propensity-matched cohort analysis using information from a Medicare database of pharmaceutical coverage for low-income elderly residents of Pennsylvania and New Jersey in 1999-2005. The study population included 12,840 adults with rheumatoid arthritis or osteoarthritis who began using one of the three types of analgesics during the study period and were followed for at least 1 year.

Overall, adverse safety event rates were high for all three groups, with the rate of adverse-event hospitalization being greater than 100 per 1,000 person-years for all three types of analgesics.

Opioid users had the highest rates of serious adverse events. Their rate of hip, pelvis, wrist, or humerus fractures was 101 per 1,000 person-years, compared with 19 per 1,000 person-years in the coxib group and 26 per 1,000 person-years in the NSAID group. Even though a link between opioids and fractures has been reported previously, “the strength of the association we observed is larger than in previous reports,” the researchers said.

Compared with NSAIDs, opioids (hazard ratio, 1.77) and coxibs (HR, 1.28) were associated with elevated risk for cardiovascular events such as MI, stroke, heart failure, revascularization, and cardiac death. That “unexpected” finding regarding such severe events warrants further study, the investigators noted.

Compared with NSAIDs, risk for upper GI bleeding, lower GI bleeding, or bowel obstruction was similarly high for opioid users (HR, 1.07) but was lower for coxib users (HR, 0.60).

In general, opioid users experienced the most adverse events over time, and NSAID users experienced the fewest. In addition, “opioid users experienced moderate risk early in treatment,” the researchers noted, whereas the other groups did not. Opioid users had significantly higher all-cause mortality (75 deaths per 1,000 person-years) than did either NSAID users (48 deaths per 1,000 person-years) or coxib users (47 deaths per 1,000 person-years).

The study findings indicate that recent concerns that have been raised regarding the use of opioids for nonmalignant pain are warranted, the researchers said.

The study was supported by the Agency for Healthcare Research and Quality. Dr. Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.

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An Oversight in Statistical Methods

The propensity matching was meticulous in this study, leading to well-balanced baseline characteristics among the three treatment groups. This reassures readers that the observational study design is as robust as possible, and that treatment effects alone account for the observed differences among opioid, NSAID, and coxib users.

However, there is a single unmeasured confounder that calls into question the validity of some of the study findings: the use of over-the-counter NSAIDs, noted Dr. William C. Becker and Dr. Patrick G. O'Connor.

It is likely that “a significant proportion” of patients in the opioid group were also taking NSAIDs, because “physicians routinely recommend antiinflammatory medication in addition to opioids to achieve therapeutic synergy in the treatment of arthritis,” they noted.

“It seems implausible that a group of 'opioid-only' elderly patients” who were actually taking supplemental NSAIDs would have a higher risk of adverse cardiovascular events, GI bleeding, and acute kidney injury than would a group taking NSAIDs alone, because these are all known effects of NSAID therapy.

Despite this limitation, “the data on falls and fracture from this … study are nonetheless compelling and carry important clinical implications,” Dr. Becker and Dr. O'Connor said.

DR. BECKER and DR. O'CONNOR are in general internal medicine at Yale University, New Haven, Conn. They reported no financial disclosures. These comments were taken from their invited commentary accompanying Dr. Solomon's report (Arch. Intern. Med. 2010;170:1986-8).

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Opioids were associated with more risks than were other analgesics in elderly patients taking the drugs for arthritis pain, according to a report in the Archives of Internal Medicine.

Although NSAIDs are known to pose certain risks, the results of the study “support the safety of [NSAIDs] compared with other analgesics,” said Dr. Daniel H. Solomon and his associates at Brigham and Women's Hospital, Boston.

Few studies have examined the relative risks of the three major analgesic groups: NSAIDs, opioids, and coxibs (selective cyclooxygenase-2 inhibitors). “Postmarketing surveillance data from usual care cohorts provide an opportunity to examine comparative safety across a wide range of events and can complement safety data from randomized controlled trials. However, imbalance in baseline population characteristics confounds many postmarketing surveillance studies,” Dr. Solomon and his colleagues noted (Arch. Intern. Med. 2010;170:1968-78). “Propensity score-matched analyses may provide better balance of confounders and facilitate relatively straightforward comparative safety analyses,” they added.

To compare safety, the researchers performed a propensity-matched cohort analysis using information from a Medicare database of pharmaceutical coverage for low-income elderly residents of Pennsylvania and New Jersey in 1999-2005. The study population included 12,840 adults with rheumatoid arthritis or osteoarthritis who began using one of the three types of analgesics during the study period and were followed for at least 1 year.

Overall, adverse safety event rates were high for all three groups, with the rate of adverse-event hospitalization being greater than 100 per 1,000 person-years for all three types of analgesics.

Opioid users had the highest rates of serious adverse events. Their rate of hip, pelvis, wrist, or humerus fractures was 101 per 1,000 person-years, compared with 19 per 1,000 person-years in the coxib group and 26 per 1,000 person-years in the NSAID group. Even though a link between opioids and fractures has been reported previously, “the strength of the association we observed is larger than in previous reports,” the researchers said.

Compared with NSAIDs, opioids (hazard ratio, 1.77) and coxibs (HR, 1.28) were associated with elevated risk for cardiovascular events such as MI, stroke, heart failure, revascularization, and cardiac death. That “unexpected” finding regarding such severe events warrants further study, the investigators noted.

Compared with NSAIDs, risk for upper GI bleeding, lower GI bleeding, or bowel obstruction was similarly high for opioid users (HR, 1.07) but was lower for coxib users (HR, 0.60).

In general, opioid users experienced the most adverse events over time, and NSAID users experienced the fewest. In addition, “opioid users experienced moderate risk early in treatment,” the researchers noted, whereas the other groups did not. Opioid users had significantly higher all-cause mortality (75 deaths per 1,000 person-years) than did either NSAID users (48 deaths per 1,000 person-years) or coxib users (47 deaths per 1,000 person-years).

The study findings indicate that recent concerns that have been raised regarding the use of opioids for nonmalignant pain are warranted, the researchers said.

The study was supported by the Agency for Healthcare Research and Quality. Dr. Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.

View on the News

An Oversight in Statistical Methods

The propensity matching was meticulous in this study, leading to well-balanced baseline characteristics among the three treatment groups. This reassures readers that the observational study design is as robust as possible, and that treatment effects alone account for the observed differences among opioid, NSAID, and coxib users.

However, there is a single unmeasured confounder that calls into question the validity of some of the study findings: the use of over-the-counter NSAIDs, noted Dr. William C. Becker and Dr. Patrick G. O'Connor.

It is likely that “a significant proportion” of patients in the opioid group were also taking NSAIDs, because “physicians routinely recommend antiinflammatory medication in addition to opioids to achieve therapeutic synergy in the treatment of arthritis,” they noted.

“It seems implausible that a group of 'opioid-only' elderly patients” who were actually taking supplemental NSAIDs would have a higher risk of adverse cardiovascular events, GI bleeding, and acute kidney injury than would a group taking NSAIDs alone, because these are all known effects of NSAID therapy.

Despite this limitation, “the data on falls and fracture from this … study are nonetheless compelling and carry important clinical implications,” Dr. Becker and Dr. O'Connor said.

DR. BECKER and DR. O'CONNOR are in general internal medicine at Yale University, New Haven, Conn. They reported no financial disclosures. These comments were taken from their invited commentary accompanying Dr. Solomon's report (Arch. Intern. Med. 2010;170:1986-8).

Opioids were associated with more risks than were other analgesics in elderly patients taking the drugs for arthritis pain, according to a report in the Archives of Internal Medicine.

Although NSAIDs are known to pose certain risks, the results of the study “support the safety of [NSAIDs] compared with other analgesics,” said Dr. Daniel H. Solomon and his associates at Brigham and Women's Hospital, Boston.

Few studies have examined the relative risks of the three major analgesic groups: NSAIDs, opioids, and coxibs (selective cyclooxygenase-2 inhibitors). “Postmarketing surveillance data from usual care cohorts provide an opportunity to examine comparative safety across a wide range of events and can complement safety data from randomized controlled trials. However, imbalance in baseline population characteristics confounds many postmarketing surveillance studies,” Dr. Solomon and his colleagues noted (Arch. Intern. Med. 2010;170:1968-78). “Propensity score-matched analyses may provide better balance of confounders and facilitate relatively straightforward comparative safety analyses,” they added.

To compare safety, the researchers performed a propensity-matched cohort analysis using information from a Medicare database of pharmaceutical coverage for low-income elderly residents of Pennsylvania and New Jersey in 1999-2005. The study population included 12,840 adults with rheumatoid arthritis or osteoarthritis who began using one of the three types of analgesics during the study period and were followed for at least 1 year.

Overall, adverse safety event rates were high for all three groups, with the rate of adverse-event hospitalization being greater than 100 per 1,000 person-years for all three types of analgesics.

Opioid users had the highest rates of serious adverse events. Their rate of hip, pelvis, wrist, or humerus fractures was 101 per 1,000 person-years, compared with 19 per 1,000 person-years in the coxib group and 26 per 1,000 person-years in the NSAID group. Even though a link between opioids and fractures has been reported previously, “the strength of the association we observed is larger than in previous reports,” the researchers said.

Compared with NSAIDs, opioids (hazard ratio, 1.77) and coxibs (HR, 1.28) were associated with elevated risk for cardiovascular events such as MI, stroke, heart failure, revascularization, and cardiac death. That “unexpected” finding regarding such severe events warrants further study, the investigators noted.

Compared with NSAIDs, risk for upper GI bleeding, lower GI bleeding, or bowel obstruction was similarly high for opioid users (HR, 1.07) but was lower for coxib users (HR, 0.60).

In general, opioid users experienced the most adverse events over time, and NSAID users experienced the fewest. In addition, “opioid users experienced moderate risk early in treatment,” the researchers noted, whereas the other groups did not. Opioid users had significantly higher all-cause mortality (75 deaths per 1,000 person-years) than did either NSAID users (48 deaths per 1,000 person-years) or coxib users (47 deaths per 1,000 person-years).

The study findings indicate that recent concerns that have been raised regarding the use of opioids for nonmalignant pain are warranted, the researchers said.

The study was supported by the Agency for Healthcare Research and Quality. Dr. Solomon reported being an unpaid member of a celecoxib trial executive committee sponsored by Pfizer and an unpaid member of the data safety monitoring board for an analgesic trial sponsored by Pfizer.

View on the News

An Oversight in Statistical Methods

The propensity matching was meticulous in this study, leading to well-balanced baseline characteristics among the three treatment groups. This reassures readers that the observational study design is as robust as possible, and that treatment effects alone account for the observed differences among opioid, NSAID, and coxib users.

However, there is a single unmeasured confounder that calls into question the validity of some of the study findings: the use of over-the-counter NSAIDs, noted Dr. William C. Becker and Dr. Patrick G. O'Connor.

It is likely that “a significant proportion” of patients in the opioid group were also taking NSAIDs, because “physicians routinely recommend antiinflammatory medication in addition to opioids to achieve therapeutic synergy in the treatment of arthritis,” they noted.

“It seems implausible that a group of 'opioid-only' elderly patients” who were actually taking supplemental NSAIDs would have a higher risk of adverse cardiovascular events, GI bleeding, and acute kidney injury than would a group taking NSAIDs alone, because these are all known effects of NSAID therapy.

Despite this limitation, “the data on falls and fracture from this … study are nonetheless compelling and carry important clinical implications,” Dr. Becker and Dr. O'Connor said.

DR. BECKER and DR. O'CONNOR are in general internal medicine at Yale University, New Haven, Conn. They reported no financial disclosures. These comments were taken from their invited commentary accompanying Dr. Solomon's report (Arch. Intern. Med. 2010;170:1986-8).

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ACR to Review Proposed OA Guideline Revisions

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ATLANTA – The best available evidence suggests that exercise should be recommended as a nonpharmacologic treatment option for hip and knee osteoarthritis.

So says a technical panel of experts convened by the American College of Rheumatology to revise existing treatment recommendations on the nonpharmacologic treatment of hand, hip, and knee OA. The panel began work in 2008; the proposed consensus revisions are now under review by the ACR.

The panel found “strong” evidence that aerobic land-based exercise, resistance land-based exercise, aquatic exercise, and weight loss for overweight patients can be helpful for reducing pain and improving physical function in hip and knee osteoarthritis, and the panel plans to recommend them, reported Carol Oatis, Ph.D., professor of physical therapy at Arcadia University in Glenside, Pa., and a panel member.

This was the only time the panel deemed supporting evidence to be “strong,” based on the GRADE (grades of recommendations, assessment, development, and evaluation) methodology used in developing the revised recommendations. GRADE rates the available evidence as “strong,” “weak,” or “none.”

Strong evidence is of high quality with a large gradient between benefits and risks, and little uncertainty or variability in values and preferences; weak evidence has moderate quality with a small gradient between benefits and risks, and moderate uncertainty or variability in values and preferences; and “none” means the evidence was of low or very low quality with no difference between benefits and risks.

Weak evidence of benefit in hip OA was found for manual therapy in combination with supervised exercise programs; the panel suggests – but does not recommend – that this modality be considered for patients with hip OA, Dr. Oatis said.

No evidence was found either in support of or against balance exercises or tai chi, so the panel provided no guidance for these approaches, Dr. Oatis said.

The panel also considered the evidence for hand OA, and for various specific nonpharmacologic approaches to treating OA.

For hand OA, weak evidence was found for the following:

▸ Evaluating patients regarding activities of daily living.

▸ Providing instruction on joint protection techniques.

▸ Providing assistive devices as needed.

▸ Instructing patients regarding the use of thermal modalities.

▸ Using splints for the trapezio-metacarpal joint (carpal metacarpal joint at the base of the thumb).

Thus, the panel “suggests” use of these modalities, said Catherine Backman, Ph.D., an occupational therapist at the University of British Columbia, Vancouver, and a panel member.

When it comes to suggestions based on weak evidence, patient preference comes into play, because this generally means there is no evidence against – and there is some evidence in favor of – use of these modalities, Dr. Backman said.

“Clinicians may want to discuss [these modalities] with patients,” she said.

No other recommendations or suggestions were made for hand OA.

As for specific treatment modalities, weak evidence was found for the following:

▸ Medial wedge shoe insoles for lateral compartment knee OA.

▸ Subtalar strapping and lateral wedge insoles for medial compartment knee OA.

▸ Medial patellar femoral taping.

▸ Transcutaneous electrical nerve stimulation (TENS) for knee OA with chronic moderate to severe pain.

▸ Traditional Chinese acupuncture for knee OA with moderate to severe pain.

▸ Thermal modalities.

▸ Walking aids.

No evidence was found for or against valgus bracing for knee OA, or for lateral patellar-femoral taping; therefore, the panel chose not to provide guidance on these, said G. Kelley Fitzgerald, Ph.D., a physical therapist at the University of Pittsburgh, and a panel member.

The panel, which reviewed existing English-language studies and existing guidelines from the ACR and other organizations, based its evidence-strength determinations on the quality of the evidence and the extent to which the evidence demonstrated pain relief and improved physical functionality.

The panel did not determine that any of the reviewed modalities should not be used.

“The lack of 'do not do' recommendations or suggestions means that there was no definitive evidence of harm or lack of efficacy for the interventions examined, Dr. Oatis explained.

These proposed revisions to the current ACR recommendations, which were last revised in 2000 with an update in 2005 following the withdrawal of rofecoxib from the market, are currently under review by the journal Arthritis Care and Research, and have been submitted to the ACR Committee on Quality of Care for review before they are sent the ACR board of directors for final approval, said Dr. Marc C. Hochberg, head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The ACR awarded the contract for the project to the University of Maryland with Dr. Hochberg as the principal investigator. He is also a member of the project steering committee.

 

 

“Hopefully, these will come to the point where the ACR board of directors will be satisfied, and we'll have a publication in 2011,” he said.

Dr. Hochberg disclosed that he has received research support from the National Institutes of Health, and has served as a consultant or on an advisory board or data safety monitoring board for numerous pharmaceutical companies. The other presenters had no disclosures.

Water aerobics can help reduce OA pain and improve physical function, and will be recommended by the panel.

Source ©Sarto/Lund/Getty Images

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ATLANTA – The best available evidence suggests that exercise should be recommended as a nonpharmacologic treatment option for hip and knee osteoarthritis.

So says a technical panel of experts convened by the American College of Rheumatology to revise existing treatment recommendations on the nonpharmacologic treatment of hand, hip, and knee OA. The panel began work in 2008; the proposed consensus revisions are now under review by the ACR.

The panel found “strong” evidence that aerobic land-based exercise, resistance land-based exercise, aquatic exercise, and weight loss for overweight patients can be helpful for reducing pain and improving physical function in hip and knee osteoarthritis, and the panel plans to recommend them, reported Carol Oatis, Ph.D., professor of physical therapy at Arcadia University in Glenside, Pa., and a panel member.

This was the only time the panel deemed supporting evidence to be “strong,” based on the GRADE (grades of recommendations, assessment, development, and evaluation) methodology used in developing the revised recommendations. GRADE rates the available evidence as “strong,” “weak,” or “none.”

Strong evidence is of high quality with a large gradient between benefits and risks, and little uncertainty or variability in values and preferences; weak evidence has moderate quality with a small gradient between benefits and risks, and moderate uncertainty or variability in values and preferences; and “none” means the evidence was of low or very low quality with no difference between benefits and risks.

Weak evidence of benefit in hip OA was found for manual therapy in combination with supervised exercise programs; the panel suggests – but does not recommend – that this modality be considered for patients with hip OA, Dr. Oatis said.

No evidence was found either in support of or against balance exercises or tai chi, so the panel provided no guidance for these approaches, Dr. Oatis said.

The panel also considered the evidence for hand OA, and for various specific nonpharmacologic approaches to treating OA.

For hand OA, weak evidence was found for the following:

▸ Evaluating patients regarding activities of daily living.

▸ Providing instruction on joint protection techniques.

▸ Providing assistive devices as needed.

▸ Instructing patients regarding the use of thermal modalities.

▸ Using splints for the trapezio-metacarpal joint (carpal metacarpal joint at the base of the thumb).

Thus, the panel “suggests” use of these modalities, said Catherine Backman, Ph.D., an occupational therapist at the University of British Columbia, Vancouver, and a panel member.

When it comes to suggestions based on weak evidence, patient preference comes into play, because this generally means there is no evidence against – and there is some evidence in favor of – use of these modalities, Dr. Backman said.

“Clinicians may want to discuss [these modalities] with patients,” she said.

No other recommendations or suggestions were made for hand OA.

As for specific treatment modalities, weak evidence was found for the following:

▸ Medial wedge shoe insoles for lateral compartment knee OA.

▸ Subtalar strapping and lateral wedge insoles for medial compartment knee OA.

▸ Medial patellar femoral taping.

▸ Transcutaneous electrical nerve stimulation (TENS) for knee OA with chronic moderate to severe pain.

▸ Traditional Chinese acupuncture for knee OA with moderate to severe pain.

▸ Thermal modalities.

▸ Walking aids.

No evidence was found for or against valgus bracing for knee OA, or for lateral patellar-femoral taping; therefore, the panel chose not to provide guidance on these, said G. Kelley Fitzgerald, Ph.D., a physical therapist at the University of Pittsburgh, and a panel member.

The panel, which reviewed existing English-language studies and existing guidelines from the ACR and other organizations, based its evidence-strength determinations on the quality of the evidence and the extent to which the evidence demonstrated pain relief and improved physical functionality.

The panel did not determine that any of the reviewed modalities should not be used.

“The lack of 'do not do' recommendations or suggestions means that there was no definitive evidence of harm or lack of efficacy for the interventions examined, Dr. Oatis explained.

These proposed revisions to the current ACR recommendations, which were last revised in 2000 with an update in 2005 following the withdrawal of rofecoxib from the market, are currently under review by the journal Arthritis Care and Research, and have been submitted to the ACR Committee on Quality of Care for review before they are sent the ACR board of directors for final approval, said Dr. Marc C. Hochberg, head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The ACR awarded the contract for the project to the University of Maryland with Dr. Hochberg as the principal investigator. He is also a member of the project steering committee.

 

 

“Hopefully, these will come to the point where the ACR board of directors will be satisfied, and we'll have a publication in 2011,” he said.

Dr. Hochberg disclosed that he has received research support from the National Institutes of Health, and has served as a consultant or on an advisory board or data safety monitoring board for numerous pharmaceutical companies. The other presenters had no disclosures.

Water aerobics can help reduce OA pain and improve physical function, and will be recommended by the panel.

Source ©Sarto/Lund/Getty Images

ATLANTA – The best available evidence suggests that exercise should be recommended as a nonpharmacologic treatment option for hip and knee osteoarthritis.

So says a technical panel of experts convened by the American College of Rheumatology to revise existing treatment recommendations on the nonpharmacologic treatment of hand, hip, and knee OA. The panel began work in 2008; the proposed consensus revisions are now under review by the ACR.

The panel found “strong” evidence that aerobic land-based exercise, resistance land-based exercise, aquatic exercise, and weight loss for overweight patients can be helpful for reducing pain and improving physical function in hip and knee osteoarthritis, and the panel plans to recommend them, reported Carol Oatis, Ph.D., professor of physical therapy at Arcadia University in Glenside, Pa., and a panel member.

This was the only time the panel deemed supporting evidence to be “strong,” based on the GRADE (grades of recommendations, assessment, development, and evaluation) methodology used in developing the revised recommendations. GRADE rates the available evidence as “strong,” “weak,” or “none.”

Strong evidence is of high quality with a large gradient between benefits and risks, and little uncertainty or variability in values and preferences; weak evidence has moderate quality with a small gradient between benefits and risks, and moderate uncertainty or variability in values and preferences; and “none” means the evidence was of low or very low quality with no difference between benefits and risks.

Weak evidence of benefit in hip OA was found for manual therapy in combination with supervised exercise programs; the panel suggests – but does not recommend – that this modality be considered for patients with hip OA, Dr. Oatis said.

No evidence was found either in support of or against balance exercises or tai chi, so the panel provided no guidance for these approaches, Dr. Oatis said.

The panel also considered the evidence for hand OA, and for various specific nonpharmacologic approaches to treating OA.

For hand OA, weak evidence was found for the following:

▸ Evaluating patients regarding activities of daily living.

▸ Providing instruction on joint protection techniques.

▸ Providing assistive devices as needed.

▸ Instructing patients regarding the use of thermal modalities.

▸ Using splints for the trapezio-metacarpal joint (carpal metacarpal joint at the base of the thumb).

Thus, the panel “suggests” use of these modalities, said Catherine Backman, Ph.D., an occupational therapist at the University of British Columbia, Vancouver, and a panel member.

When it comes to suggestions based on weak evidence, patient preference comes into play, because this generally means there is no evidence against – and there is some evidence in favor of – use of these modalities, Dr. Backman said.

“Clinicians may want to discuss [these modalities] with patients,” she said.

No other recommendations or suggestions were made for hand OA.

As for specific treatment modalities, weak evidence was found for the following:

▸ Medial wedge shoe insoles for lateral compartment knee OA.

▸ Subtalar strapping and lateral wedge insoles for medial compartment knee OA.

▸ Medial patellar femoral taping.

▸ Transcutaneous electrical nerve stimulation (TENS) for knee OA with chronic moderate to severe pain.

▸ Traditional Chinese acupuncture for knee OA with moderate to severe pain.

▸ Thermal modalities.

▸ Walking aids.

No evidence was found for or against valgus bracing for knee OA, or for lateral patellar-femoral taping; therefore, the panel chose not to provide guidance on these, said G. Kelley Fitzgerald, Ph.D., a physical therapist at the University of Pittsburgh, and a panel member.

The panel, which reviewed existing English-language studies and existing guidelines from the ACR and other organizations, based its evidence-strength determinations on the quality of the evidence and the extent to which the evidence demonstrated pain relief and improved physical functionality.

The panel did not determine that any of the reviewed modalities should not be used.

“The lack of 'do not do' recommendations or suggestions means that there was no definitive evidence of harm or lack of efficacy for the interventions examined, Dr. Oatis explained.

These proposed revisions to the current ACR recommendations, which were last revised in 2000 with an update in 2005 following the withdrawal of rofecoxib from the market, are currently under review by the journal Arthritis Care and Research, and have been submitted to the ACR Committee on Quality of Care for review before they are sent the ACR board of directors for final approval, said Dr. Marc C. Hochberg, head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The ACR awarded the contract for the project to the University of Maryland with Dr. Hochberg as the principal investigator. He is also a member of the project steering committee.

 

 

“Hopefully, these will come to the point where the ACR board of directors will be satisfied, and we'll have a publication in 2011,” he said.

Dr. Hochberg disclosed that he has received research support from the National Institutes of Health, and has served as a consultant or on an advisory board or data safety monitoring board for numerous pharmaceutical companies. The other presenters had no disclosures.

Water aerobics can help reduce OA pain and improve physical function, and will be recommended by the panel.

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