Osteoarthritis

When it comes to managing chronic pain, have physicians been looking in the wrong places? Physical findings in peripheral tissues rarely match up with patients’ reports of pain, or vice versa. Yet, clinicians typically examine only the area where the patient reports the pain, rather than looking at the whole body and considering that the patient’s perception of persistent pain may have a more central origin, according to pain expert Dr. Daniel J. Clauw.

Photo credit: Flickr user Kira.Belle (Creative Commons)

“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,” Dr. Clauw said at last week at a 2-day scientific workshop on pain and musculoskeletal disorders, sponsored by the University of Michigan and held on the Bethesda, Md., campus of the National Institutes of Health.

That narrow focus has led many medical professionals to assume that when there is a disparity between peripheral findings and pain, the pain must be caused primarily by psychological factors. A prime example is fibromyalgia, still a somewhat controversial diagnosis. But as the first chronic pain syndrome identified as NOT being caused by peripheral inflammation or damage, fibromyalgia is “a metaphor for the centrality of chronic pain,” Dr. Clauw said.

So what should clinicians do differently? First, look beyond the immediate area the patient is complaining about. Has the patient had pain in other parts of the body? Experience frequent headaches? Have irritable bowel? Previous chronic neck pain, and now pain in the hip? “To me as a pain researcher, this is a blinking neon light that the person has a problem with pain processing. It may be that the particular symptom they’re coming in with is due to increased volume control setting rather than a pathologic problem in that part of the body,” Dr. Clauw told me.

And treatment? Ensuring adequate exercise and sleep and reducing stress are important yet underemphasized. Cognitive behavior therapy also has been shown to help. Pharmacologic therapy that acts centrally, rather than peripherally, may also be effective. The antidepressant duloxetine (Cymbalta), for example, is a serotonin/norepinephrine reuptake inhibitor that has been recently approved to treat osteoarthritis of the hip and low back pain, in addition to fibromyalgia and diabetic peripheral nerve pain.

A major challenge, Dr. Clauw believes, might be in getting clinicians to change their approach to pain. “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. It’s a major paradigm shift.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

g to the report, last spring Mr. Hamman was invited by the American College of Cardiology to participate in a seminar on fostering teamwork. He also spoke at continuing medical education events sponsored by the American Medical Association and the American College of Emergency Physicians.

There was one problem, though. He had no medical degree, a fact that was uncovered by Beaumont staff when he submitted paperwork for a grant last spring.

“I was shocked to hear the news,” Dr. W. Douglas Weaver, who was president of the ACC when it awarded Mr. Hamman a training contract a few years ago, was quoted as saying in the article. “He was totally dedicated to what he was doing, and there is a real need for team-based education in medicine.”

— Doug Brunk (on Twitter @dougbrunk)

When it comes to managing chronic pain, have physicians been looking in the wrong places? Physical findings in peripheral tissues rarely match up with patients’ reports of pain, or vice versa. Yet, clinicians typically examine only the area where the patient reports the pain, rather than looking at the whole body and considering that the patient’s perception of persistent pain may have a more central origin, according to pain expert Dr. Daniel J. Clauw.

Photo credit: Flickr user Kira.Belle (Creative Commons)

“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,” Dr. Clauw said at last week at a 2-day scientific workshop on pain and musculoskeletal disorders, sponsored by the University of Michigan and held on the Bethesda, Md., campus of the National Institutes of Health.

That narrow focus has led many medical professionals to assume that when there is a disparity between peripheral findings and pain, the pain must be caused primarily by psychological factors. A prime example is fibromyalgia, still a somewhat controversial diagnosis. But as the first chronic pain syndrome identified as NOT being caused by peripheral inflammation or damage, fibromyalgia is “a metaphor for the centrality of chronic pain,” Dr. Clauw said.

So what should clinicians do differently? First, look beyond the immediate area the patient is complaining about. Has the patient had pain in other parts of the body? Experience frequent headaches? Have irritable bowel? Previous chronic neck pain, and now pain in the hip? “To me as a pain researcher, this is a blinking neon light that the person has a problem with pain processing. It may be that the particular symptom they’re coming in with is due to increased volume control setting rather than a pathologic problem in that part of the body,” Dr. Clauw told me.

And treatment? Ensuring adequate exercise and sleep and reducing stress are important yet underemphasized. Cognitive behavior therapy also has been shown to help. Pharmacologic therapy that acts centrally, rather than peripherally, may also be effective. The antidepressant duloxetine (Cymbalta), for example, is a serotonin/norepinephrine reuptake inhibitor that has been recently approved to treat osteoarthritis of the hip and low back pain, in addition to fibromyalgia and diabetic peripheral nerve pain.

A major challenge, Dr. Clauw believes, might be in getting clinicians to change their approach to pain. “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. It’s a major paradigm shift.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

g to the report, last spring Mr. Hamman was invited by the American College of Cardiology to participate in a seminar on fostering teamwork. He also spoke at continuing medical education events sponsored by the American Medical Association and the American College of Emergency Physicians.

There was one problem, though. He had no medical degree, a fact that was uncovered by Beaumont staff when he submitted paperwork for a grant last spring.

“I was shocked to hear the news,” Dr. W. Douglas Weaver, who was president of the ACC when it awarded Mr. Hamman a training contract a few years ago, was quoted as saying in the article. “He was totally dedicated to what he was doing, and there is a real need for team-based education in medicine.”

— Doug Brunk (on Twitter @dougbrunk)

When it comes to managing chronic pain, have physicians been looking in the wrong places? Physical findings in peripheral tissues rarely match up with patients’ reports of pain, or vice versa. Yet, clinicians typically examine only the area where the patient reports the pain, rather than looking at the whole body and considering that the patient’s perception of persistent pain may have a more central origin, according to pain expert Dr. Daniel J. Clauw.

Photo credit: Flickr user Kira.Belle (Creative Commons)

“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,” Dr. Clauw said at last week at a 2-day scientific workshop on pain and musculoskeletal disorders, sponsored by the University of Michigan and held on the Bethesda, Md., campus of the National Institutes of Health.

That narrow focus has led many medical professionals to assume that when there is a disparity between peripheral findings and pain, the pain must be caused primarily by psychological factors. A prime example is fibromyalgia, still a somewhat controversial diagnosis. But as the first chronic pain syndrome identified as NOT being caused by peripheral inflammation or damage, fibromyalgia is “a metaphor for the centrality of chronic pain,” Dr. Clauw said.

So what should clinicians do differently? First, look beyond the immediate area the patient is complaining about. Has the patient had pain in other parts of the body? Experience frequent headaches? Have irritable bowel? Previous chronic neck pain, and now pain in the hip? “To me as a pain researcher, this is a blinking neon light that the person has a problem with pain processing. It may be that the particular symptom they’re coming in with is due to increased volume control setting rather than a pathologic problem in that part of the body,” Dr. Clauw told me.

And treatment? Ensuring adequate exercise and sleep and reducing stress are important yet underemphasized. Cognitive behavior therapy also has been shown to help. Pharmacologic therapy that acts centrally, rather than peripherally, may also be effective. The antidepressant duloxetine (Cymbalta), for example, is a serotonin/norepinephrine reuptake inhibitor that has been recently approved to treat osteoarthritis of the hip and low back pain, in addition to fibromyalgia and diabetic peripheral nerve pain.

A major challenge, Dr. Clauw believes, might be in getting clinicians to change their approach to pain. “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. It’s a major paradigm shift.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

g to the report, last spring Mr. Hamman was invited by the American College of Cardiology to participate in a seminar on fostering teamwork. He also spoke at continuing medical education events sponsored by the American Medical Association and the American College of Emergency Physicians.

There was one problem, though. He had no medical degree, a fact that was uncovered by Beaumont staff when he submitted paperwork for a grant last spring.

“I was shocked to hear the news,” Dr. W. Douglas Weaver, who was president of the ACC when it awarded Mr. Hamman a training contract a few years ago, was quoted as saying in the article. “He was totally dedicated to what he was doing, and there is a real need for team-based education in medicine.”

— Doug Brunk (on Twitter @dougbrunk)

ATLANTA – Ultrasound guidance led to a significant increase in the number of noneffusive knees with osteoarthritis that responded to corticosteroid injections, based on data from a randomized trial of 94 knees. The findings were presented at the annual meeting of the American College of Rheumatology.

The accuracy rate for knee injections in OA varies widely, said Dr. Wilmer Sibbitt, professor of rheumatology and neurology at the University of New Mexico Health Sciences Center in Albuquerque.

Injections of medication or removal of fluid from the knee joints have historically been guided by the physician’s hands-on examination of the knee, but ultrasound guidance is becoming more common as a way to improve accuracy, said Dr. Sibbitt.

"Ultrasound is being used presently for injections, and there aren’t good outcome studies to determine whether this increased accuracy provides better results, and whether it increases or reduces costs," he said in an interview.

Dr. Sibbitt and colleagues randomized adults with knee OA to receive joint injections guided by ultrasound or with the conventional palpation guidance. For the sonographically guided injections, the researchers used a one-handed reciprocating procedure device syringe that enabled them to hold the ultrasound transducer in one hand and the dual chamber syringe in the other. The injection consisted of 80 mg of triamcinolone acetonide.

The researchers evaluated patients’ pain at baseline, during the injection, 2 weeks later, and 6 months later, using an established pain rating scale.

Compared with the conventional injection group, ultrasound-guided injections yielded a 48% reduction in pain during the injection, and a 42% reduction in pain scores at follow-up. In addition, significantly more knees in the ultrasound group than in the control group responded well to the injections and significantly fewer knees in the ultrasound group than in the control group did not respond well.

The researchers also evaluated the cost-effectiveness of ultrasound-guided injections. The ultrasound-guided injection was associated with a $48 reduction in patient costs per year, and a $593 reduction in outpatient costs per year.

The study was limited by its small size, and additional research is needed to confirm the results. But the findings suggest that sonographic needle guidance improves the performance, clinical outcomes, and effectiveness of knee injections for OA patients, Dr. Sibbitt said.

Dr. Sibbitt disclosed receiving consulting fees from multiple companies including Becton Dickinson, Ferring Pharmaceuticals, Avasca Medical, and Meditech Duopross. He also disclosed stock, stock options, or bond holdings in multiple companies including Celgene, Apple, Avasca, and Java Inc. He has received research grants from the National Institutes of Health.

ATLANTA – Ultrasound guidance led to a significant increase in the number of noneffusive knees with osteoarthritis that responded to corticosteroid injections, based on data from a randomized trial of 94 knees. The findings were presented at the annual meeting of the American College of Rheumatology.

The accuracy rate for knee injections in OA varies widely, said Dr. Wilmer Sibbitt, professor of rheumatology and neurology at the University of New Mexico Health Sciences Center in Albuquerque.

Injections of medication or removal of fluid from the knee joints have historically been guided by the physician’s hands-on examination of the knee, but ultrasound guidance is becoming more common as a way to improve accuracy, said Dr. Sibbitt.

"Ultrasound is being used presently for injections, and there aren’t good outcome studies to determine whether this increased accuracy provides better results, and whether it increases or reduces costs," he said in an interview.

Dr. Sibbitt and colleagues randomized adults with knee OA to receive joint injections guided by ultrasound or with the conventional palpation guidance. For the sonographically guided injections, the researchers used a one-handed reciprocating procedure device syringe that enabled them to hold the ultrasound transducer in one hand and the dual chamber syringe in the other. The injection consisted of 80 mg of triamcinolone acetonide.

The researchers evaluated patients’ pain at baseline, during the injection, 2 weeks later, and 6 months later, using an established pain rating scale.

Compared with the conventional injection group, ultrasound-guided injections yielded a 48% reduction in pain during the injection, and a 42% reduction in pain scores at follow-up. In addition, significantly more knees in the ultrasound group than in the control group responded well to the injections and significantly fewer knees in the ultrasound group than in the control group did not respond well.

The researchers also evaluated the cost-effectiveness of ultrasound-guided injections. The ultrasound-guided injection was associated with a $48 reduction in patient costs per year, and a $593 reduction in outpatient costs per year.

The study was limited by its small size, and additional research is needed to confirm the results. But the findings suggest that sonographic needle guidance improves the performance, clinical outcomes, and effectiveness of knee injections for OA patients, Dr. Sibbitt said.

Dr. Sibbitt disclosed receiving consulting fees from multiple companies including Becton Dickinson, Ferring Pharmaceuticals, Avasca Medical, and Meditech Duopross. He also disclosed stock, stock options, or bond holdings in multiple companies including Celgene, Apple, Avasca, and Java Inc. He has received research grants from the National Institutes of Health.

ATLANTA – Ultrasound guidance led to a significant increase in the number of noneffusive knees with osteoarthritis that responded to corticosteroid injections, based on data from a randomized trial of 94 knees. The findings were presented at the annual meeting of the American College of Rheumatology.

The accuracy rate for knee injections in OA varies widely, said Dr. Wilmer Sibbitt, professor of rheumatology and neurology at the University of New Mexico Health Sciences Center in Albuquerque.

Injections of medication or removal of fluid from the knee joints have historically been guided by the physician’s hands-on examination of the knee, but ultrasound guidance is becoming more common as a way to improve accuracy, said Dr. Sibbitt.

"Ultrasound is being used presently for injections, and there aren’t good outcome studies to determine whether this increased accuracy provides better results, and whether it increases or reduces costs," he said in an interview.

Dr. Sibbitt and colleagues randomized adults with knee OA to receive joint injections guided by ultrasound or with the conventional palpation guidance. For the sonographically guided injections, the researchers used a one-handed reciprocating procedure device syringe that enabled them to hold the ultrasound transducer in one hand and the dual chamber syringe in the other. The injection consisted of 80 mg of triamcinolone acetonide.

The researchers evaluated patients’ pain at baseline, during the injection, 2 weeks later, and 6 months later, using an established pain rating scale.

Compared with the conventional injection group, ultrasound-guided injections yielded a 48% reduction in pain during the injection, and a 42% reduction in pain scores at follow-up. In addition, significantly more knees in the ultrasound group than in the control group responded well to the injections and significantly fewer knees in the ultrasound group than in the control group did not respond well.

The researchers also evaluated the cost-effectiveness of ultrasound-guided injections. The ultrasound-guided injection was associated with a $48 reduction in patient costs per year, and a $593 reduction in outpatient costs per year.

The study was limited by its small size, and additional research is needed to confirm the results. But the findings suggest that sonographic needle guidance improves the performance, clinical outcomes, and effectiveness of knee injections for OA patients, Dr. Sibbitt said.

Dr. Sibbitt disclosed receiving consulting fees from multiple companies including Becton Dickinson, Ferring Pharmaceuticals, Avasca Medical, and Meditech Duopross. He also disclosed stock, stock options, or bond holdings in multiple companies including Celgene, Apple, Avasca, and Java Inc. He has received research grants from the National Institutes of Health.

Major Finding: Patients withdrawn from bisphosphonate treatment after 5 years on the drug with a total hip T score of more than −1.5 had a 9% risk for any clinical fracture during the following 5 years. Patients with a T score of −1.5 to −2.1 at the time bisphosphonate treatment stopped had a 23% fracture rate during the next 5 years. Patients with a total hip T score of less than −2.1 had a 33% fracture rate during the 5 years after bisphosphonate withdrawal.

Data Source: Review of 437 postmenopausal women enrolled in the FLEX study who were randomized to placebo following 5 years of continuous alendronate treatment.

Disclosures: Dr. Bauer said he received research funding from Amgen, Merck, and Novartis. The FLEX study was sponsored by Merck.

TORONTO — The stronger a patient's bones are when bisphosphonate treatment is stopped, the less likely the bones are to fracture later, based on an analysis of 437 patients.

In contrast, changes in bone mineral density following the end of bisphosphonate therapy had no significant link with subsequent fracture risk, said Dr. Douglas C. Bauer of the University of California, San Francisco

The finding calls into doubt the common practice of running annual dual-energy x-ray absorptiometry examinations on patients who have withdrawn from bisphosphonate treatment.

Routine BMD measurement “1–2 years after stopping prolonged alendronate therapy may not be useful for predicting the patient's fracture risk,” Dr. Bauer said. The BMD at the time of alendronate discontinuation “was highly predictive of who was going to fracture.”

Patients who stopped alendronate therapy with a total hip BMD T score of −1.4 or greater had a 9% rate of clinical fracture during 5 years of follow-up.

Patients with a T score of −2.1 to −1.5 when they stopped bisphosphonate treatment had a 23% fracture rate during 5 years of follow-up, and those who stopped with a T score lower than −2.1 had a 33% fracture rate over the next 5 years. The between-group differences were statistically significant.

Dr. Bauer and his associates used data collected in the FLEX (Fracture Intervention Trial Long-Term Extension) study, which randomized 1,099 postmenopausal women who had completed 5 years of treatment with alendronate to either continue on alendronate for another 5 years or switch to placebo (JAMA 2006;296:2927–38). They focused on the 437 patients who switched to placebo.

Even among patients who had relatively substantial bone loss during 1 year of follow-up, the amount of lost BMD did not significantly correlate with their follow-up fracture rate.

The researchers saw no significant link to fracture rate among the 21% of patients who lost at least 3% of their BMD during the first year of follow-up, or among the 8% of patients who lost at least 5% of their BMD during 1 year of follow-up.

Major Finding: Patients withdrawn from bisphosphonate treatment after 5 years on the drug with a total hip T score of more than −1.5 had a 9% risk for any clinical fracture during the following 5 years. Patients with a T score of −1.5 to −2.1 at the time bisphosphonate treatment stopped had a 23% fracture rate during the next 5 years. Patients with a total hip T score of less than −2.1 had a 33% fracture rate during the 5 years after bisphosphonate withdrawal.

Data Source: Review of 437 postmenopausal women enrolled in the FLEX study who were randomized to placebo following 5 years of continuous alendronate treatment.

Disclosures: Dr. Bauer said he received research funding from Amgen, Merck, and Novartis. The FLEX study was sponsored by Merck.

TORONTO — The stronger a patient's bones are when bisphosphonate treatment is stopped, the less likely the bones are to fracture later, based on an analysis of 437 patients.

In contrast, changes in bone mineral density following the end of bisphosphonate therapy had no significant link with subsequent fracture risk, said Dr. Douglas C. Bauer of the University of California, San Francisco

The finding calls into doubt the common practice of running annual dual-energy x-ray absorptiometry examinations on patients who have withdrawn from bisphosphonate treatment.

Routine BMD measurement “1–2 years after stopping prolonged alendronate therapy may not be useful for predicting the patient's fracture risk,” Dr. Bauer said. The BMD at the time of alendronate discontinuation “was highly predictive of who was going to fracture.”

Patients who stopped alendronate therapy with a total hip BMD T score of −1.4 or greater had a 9% rate of clinical fracture during 5 years of follow-up.

Patients with a T score of −2.1 to −1.5 when they stopped bisphosphonate treatment had a 23% fracture rate during 5 years of follow-up, and those who stopped with a T score lower than −2.1 had a 33% fracture rate over the next 5 years. The between-group differences were statistically significant.

Dr. Bauer and his associates used data collected in the FLEX (Fracture Intervention Trial Long-Term Extension) study, which randomized 1,099 postmenopausal women who had completed 5 years of treatment with alendronate to either continue on alendronate for another 5 years or switch to placebo (JAMA 2006;296:2927–38). They focused on the 437 patients who switched to placebo.

Even among patients who had relatively substantial bone loss during 1 year of follow-up, the amount of lost BMD did not significantly correlate with their follow-up fracture rate.

The researchers saw no significant link to fracture rate among the 21% of patients who lost at least 3% of their BMD during the first year of follow-up, or among the 8% of patients who lost at least 5% of their BMD during 1 year of follow-up.

Major Finding: Patients withdrawn from bisphosphonate treatment after 5 years on the drug with a total hip T score of more than −1.5 had a 9% risk for any clinical fracture during the following 5 years. Patients with a T score of −1.5 to −2.1 at the time bisphosphonate treatment stopped had a 23% fracture rate during the next 5 years. Patients with a total hip T score of less than −2.1 had a 33% fracture rate during the 5 years after bisphosphonate withdrawal.

Data Source: Review of 437 postmenopausal women enrolled in the FLEX study who were randomized to placebo following 5 years of continuous alendronate treatment.

Disclosures: Dr. Bauer said he received research funding from Amgen, Merck, and Novartis. The FLEX study was sponsored by Merck.

TORONTO — The stronger a patient's bones are when bisphosphonate treatment is stopped, the less likely the bones are to fracture later, based on an analysis of 437 patients.

In contrast, changes in bone mineral density following the end of bisphosphonate therapy had no significant link with subsequent fracture risk, said Dr. Douglas C. Bauer of the University of California, San Francisco

The finding calls into doubt the common practice of running annual dual-energy x-ray absorptiometry examinations on patients who have withdrawn from bisphosphonate treatment.

Routine BMD measurement “1–2 years after stopping prolonged alendronate therapy may not be useful for predicting the patient's fracture risk,” Dr. Bauer said. The BMD at the time of alendronate discontinuation “was highly predictive of who was going to fracture.”

Patients who stopped alendronate therapy with a total hip BMD T score of −1.4 or greater had a 9% rate of clinical fracture during 5 years of follow-up.

Patients with a T score of −2.1 to −1.5 when they stopped bisphosphonate treatment had a 23% fracture rate during 5 years of follow-up, and those who stopped with a T score lower than −2.1 had a 33% fracture rate over the next 5 years. The between-group differences were statistically significant.

Dr. Bauer and his associates used data collected in the FLEX (Fracture Intervention Trial Long-Term Extension) study, which randomized 1,099 postmenopausal women who had completed 5 years of treatment with alendronate to either continue on alendronate for another 5 years or switch to placebo (JAMA 2006;296:2927–38). They focused on the 437 patients who switched to placebo.

Even among patients who had relatively substantial bone loss during 1 year of follow-up, the amount of lost BMD did not significantly correlate with their follow-up fracture rate.

The researchers saw no significant link to fracture rate among the 21% of patients who lost at least 3% of their BMD during the first year of follow-up, or among the 8% of patients who lost at least 5% of their BMD during 1 year of follow-up.

TORONTO — Patients who continued annual treatment with zoledronic acid for 6 years had significantly better bone mineral density and fewer morphometric vertebral fractures than did patients who received 3 years of treatment and then stopped, in a controlled study with more than 1,200 patients.

Six continuous years of annual zoledronic acid treatment also proved safe, making continued treatment with this bisphosphonate formulation an option for patients who might benefit, said Dennis M. Black, Ph.D., professor of epidemiology and biostatistics at the University of California, San Francisco.

“After 3 years, it might be beneficial for some women, particularly those at high vertebral fracture risk, to continue zoledronic acid for an additional 3 years,” he said.

“These new findings show that continued treatment with zoledronic acid for 6 years continues to maintain bone mass and reduced vertebral fracture risk with no change to its favorable safety profile compared with discontinuation of treatment after 3 years,” Dr. Black said in a written statement.

On the other hand, the decision to continue bisphosphonate treatment long term must be individualized, he said. It may be possible to identify women who would benefit from a drug holiday.

The new zoledronic acid findings came from an extension of the Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial, which compared a single, annual infusion of zoledronic acid with placebo in postmenopausal women with osteoporosis during 3 years of treatment (N. Engl. J. Med. 2007;356:1809–22). D

Dr. Black and his associates randomized 1,233 women who completed the zoledronic acid arm of the study to either continue with another 3 years of annual infusions of 5 mg zoledronic acid or switch to placebo.

Their average age was 76, and about 55% had a femoral neck T score of less than −2.5.

At the end of the study, the percent change in femoral neck bone mineral density, compared with the level at entry into the study, averaged 1% higher in patients treated with zoledronic acid, a statistically significant difference in the study's primary end point.

Femoral neck bone mineral density in the zoledronic acid–treated patients increased by an average of 1.4% over their baseline 6 years earlier (when they started on the drug), compared with those who switched off the bisphosphonate after 3 years, also a statistically significant difference.

The rate of morphometric vertebral fractures during the 3 years of the new study totaled 6% in the patients on placebo and 3% in those on zoledronic acid, a statistically significant difference.

The HORIZON trial was funded by Novartis, which markets zoledronic acid (Aclasta).

Dr. Black said that he has served as a consultant and done teaching for Amgen Inc. and Nycomed, and that he has received research contracts from Amgen, Merck & Co., Novartis, and Roche/Genentech.

TORONTO — Patients who continued annual treatment with zoledronic acid for 6 years had significantly better bone mineral density and fewer morphometric vertebral fractures than did patients who received 3 years of treatment and then stopped, in a controlled study with more than 1,200 patients.

Six continuous years of annual zoledronic acid treatment also proved safe, making continued treatment with this bisphosphonate formulation an option for patients who might benefit, said Dennis M. Black, Ph.D., professor of epidemiology and biostatistics at the University of California, San Francisco.

“After 3 years, it might be beneficial for some women, particularly those at high vertebral fracture risk, to continue zoledronic acid for an additional 3 years,” he said.

“These new findings show that continued treatment with zoledronic acid for 6 years continues to maintain bone mass and reduced vertebral fracture risk with no change to its favorable safety profile compared with discontinuation of treatment after 3 years,” Dr. Black said in a written statement.

On the other hand, the decision to continue bisphosphonate treatment long term must be individualized, he said. It may be possible to identify women who would benefit from a drug holiday.

The new zoledronic acid findings came from an extension of the Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial, which compared a single, annual infusion of zoledronic acid with placebo in postmenopausal women with osteoporosis during 3 years of treatment (N. Engl. J. Med. 2007;356:1809–22). D

Dr. Black and his associates randomized 1,233 women who completed the zoledronic acid arm of the study to either continue with another 3 years of annual infusions of 5 mg zoledronic acid or switch to placebo.

Their average age was 76, and about 55% had a femoral neck T score of less than −2.5.

At the end of the study, the percent change in femoral neck bone mineral density, compared with the level at entry into the study, averaged 1% higher in patients treated with zoledronic acid, a statistically significant difference in the study's primary end point.

Femoral neck bone mineral density in the zoledronic acid–treated patients increased by an average of 1.4% over their baseline 6 years earlier (when they started on the drug), compared with those who switched off the bisphosphonate after 3 years, also a statistically significant difference.

The rate of morphometric vertebral fractures during the 3 years of the new study totaled 6% in the patients on placebo and 3% in those on zoledronic acid, a statistically significant difference.

The HORIZON trial was funded by Novartis, which markets zoledronic acid (Aclasta).

Dr. Black said that he has served as a consultant and done teaching for Amgen Inc. and Nycomed, and that he has received research contracts from Amgen, Merck & Co., Novartis, and Roche/Genentech.

TORONTO — Patients who continued annual treatment with zoledronic acid for 6 years had significantly better bone mineral density and fewer morphometric vertebral fractures than did patients who received 3 years of treatment and then stopped, in a controlled study with more than 1,200 patients.

Six continuous years of annual zoledronic acid treatment also proved safe, making continued treatment with this bisphosphonate formulation an option for patients who might benefit, said Dennis M. Black, Ph.D., professor of epidemiology and biostatistics at the University of California, San Francisco.

“After 3 years, it might be beneficial for some women, particularly those at high vertebral fracture risk, to continue zoledronic acid for an additional 3 years,” he said.

“These new findings show that continued treatment with zoledronic acid for 6 years continues to maintain bone mass and reduced vertebral fracture risk with no change to its favorable safety profile compared with discontinuation of treatment after 3 years,” Dr. Black said in a written statement.

On the other hand, the decision to continue bisphosphonate treatment long term must be individualized, he said. It may be possible to identify women who would benefit from a drug holiday.

The new zoledronic acid findings came from an extension of the Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial, which compared a single, annual infusion of zoledronic acid with placebo in postmenopausal women with osteoporosis during 3 years of treatment (N. Engl. J. Med. 2007;356:1809–22). D

Dr. Black and his associates randomized 1,233 women who completed the zoledronic acid arm of the study to either continue with another 3 years of annual infusions of 5 mg zoledronic acid or switch to placebo.

Their average age was 76, and about 55% had a femoral neck T score of less than −2.5.

At the end of the study, the percent change in femoral neck bone mineral density, compared with the level at entry into the study, averaged 1% higher in patients treated with zoledronic acid, a statistically significant difference in the study's primary end point.

Femoral neck bone mineral density in the zoledronic acid–treated patients increased by an average of 1.4% over their baseline 6 years earlier (when they started on the drug), compared with those who switched off the bisphosphonate after 3 years, also a statistically significant difference.

The rate of morphometric vertebral fractures during the 3 years of the new study totaled 6% in the patients on placebo and 3% in those on zoledronic acid, a statistically significant difference.

The HORIZON trial was funded by Novartis, which markets zoledronic acid (Aclasta).

Dr. Black said that he has served as a consultant and done teaching for Amgen Inc. and Nycomed, and that he has received research contracts from Amgen, Merck & Co., Novartis, and Roche/Genentech.

Major Finding: People taking 792–2,000 IU/day of vitamin D had a statistically significant, 14% reduced rate of any nonvertebral fracture and a significant, 30% reduced rate of hip fractures compared with control subjects who did not receive a vitamin D supplement.

Data Source: Meta-analysis of 11 double-blind, randomized, controlled trials with individual participant data available for 31,022 subjects with an average age of 76.

Disclosures: Dr. Bischoff-Ferrari said that she had no disclosures.

TORONTO — A daily vitamin D dose of at least 792 IU was linked with significantly reduced rates of nonvertebral fractures and hip fractures in a meta-analysis of data from 11 randomized, controlled trials.

But the benefit from vitamin D appeared blunted when combined with a higher calcium dose, or when patients received vitamin D once yearly, Dr. Heike A. Bischoff-Ferrari reported.

In the meta-analysis, patients in the highest quartile for daily vitamin D intake, 792–2000 IU, had a statistically significant 14% reduced rate of any nonvertebral fracture and a significant 30% reduced rate of hip fractures after adjusting for age, gender, and type of dwelling, said Dr. Bischoff-Ferrari, a rheumatologist at the University of Zurich.

Her meta-analysis pooled individual participant data from 12 double-blind, randomized, controlled trials that examined the impact of vitamin D supplements on fracture rate in people aged 65 years or older published through June 2010, and for which she could obtain individual participant data. The primary analysis focused on the 11 studies of the 12 in which participants received the supplement at least monthly, with 31,022 people enrolled. The twelfth study tested once annual dosing, and the researchers included those data in a separate analysis. The participants' average age was 76 years, and about 90% were women.

The analysis divided the study subjects into the control group, with more than 15,000 people, and then into quartiles of their received amount of vitamin D, including both their study-treatment dose and any additional vitamin D intake. The analysis also took into account adherence to treatment. Each vitamin D quartile contained nearly 4,000 people, with a daily dose range of 792–2,000 IU forming the top quartile. Only the top quartile of vitamin intake linked with statistically significant differences, compared with the controls, for any nonvertebral fracture and for hip fracture.

An additional analysis that looked at the interaction of calcium supplements along with vitamin D showed that, with a daily calcium dose below 1,000 mg/day, a high-dose vitamin D supplement (792–2,000 IU/day) linked with a statistically significant reduction in nonvertebral fractures, but when the daily calcium supplement delivered 1,000 mg or more, this amount of vitamin D did not associate with any significant change in fracture rate, suggesting an adverse effect from higher calcium intake.

Vitals

Source ©Joss/Fotolia.com

Major Finding: People taking 792–2,000 IU/day of vitamin D had a statistically significant, 14% reduced rate of any nonvertebral fracture and a significant, 30% reduced rate of hip fractures compared with control subjects who did not receive a vitamin D supplement.

Data Source: Meta-analysis of 11 double-blind, randomized, controlled trials with individual participant data available for 31,022 subjects with an average age of 76.

Disclosures: Dr. Bischoff-Ferrari said that she had no disclosures.

TORONTO — A daily vitamin D dose of at least 792 IU was linked with significantly reduced rates of nonvertebral fractures and hip fractures in a meta-analysis of data from 11 randomized, controlled trials.

But the benefit from vitamin D appeared blunted when combined with a higher calcium dose, or when patients received vitamin D once yearly, Dr. Heike A. Bischoff-Ferrari reported.

In the meta-analysis, patients in the highest quartile for daily vitamin D intake, 792–2000 IU, had a statistically significant 14% reduced rate of any nonvertebral fracture and a significant 30% reduced rate of hip fractures after adjusting for age, gender, and type of dwelling, said Dr. Bischoff-Ferrari, a rheumatologist at the University of Zurich.

Her meta-analysis pooled individual participant data from 12 double-blind, randomized, controlled trials that examined the impact of vitamin D supplements on fracture rate in people aged 65 years or older published through June 2010, and for which she could obtain individual participant data. The primary analysis focused on the 11 studies of the 12 in which participants received the supplement at least monthly, with 31,022 people enrolled. The twelfth study tested once annual dosing, and the researchers included those data in a separate analysis. The participants' average age was 76 years, and about 90% were women.

The analysis divided the study subjects into the control group, with more than 15,000 people, and then into quartiles of their received amount of vitamin D, including both their study-treatment dose and any additional vitamin D intake. The analysis also took into account adherence to treatment. Each vitamin D quartile contained nearly 4,000 people, with a daily dose range of 792–2,000 IU forming the top quartile. Only the top quartile of vitamin intake linked with statistically significant differences, compared with the controls, for any nonvertebral fracture and for hip fracture.

An additional analysis that looked at the interaction of calcium supplements along with vitamin D showed that, with a daily calcium dose below 1,000 mg/day, a high-dose vitamin D supplement (792–2,000 IU/day) linked with a statistically significant reduction in nonvertebral fractures, but when the daily calcium supplement delivered 1,000 mg or more, this amount of vitamin D did not associate with any significant change in fracture rate, suggesting an adverse effect from higher calcium intake.

Vitals

Source ©Joss/Fotolia.com

Major Finding: People taking 792–2,000 IU/day of vitamin D had a statistically significant, 14% reduced rate of any nonvertebral fracture and a significant, 30% reduced rate of hip fractures compared with control subjects who did not receive a vitamin D supplement.

Data Source: Meta-analysis of 11 double-blind, randomized, controlled trials with individual participant data available for 31,022 subjects with an average age of 76.

Disclosures: Dr. Bischoff-Ferrari said that she had no disclosures.

TORONTO — A daily vitamin D dose of at least 792 IU was linked with significantly reduced rates of nonvertebral fractures and hip fractures in a meta-analysis of data from 11 randomized, controlled trials.

But the benefit from vitamin D appeared blunted when combined with a higher calcium dose, or when patients received vitamin D once yearly, Dr. Heike A. Bischoff-Ferrari reported.

In the meta-analysis, patients in the highest quartile for daily vitamin D intake, 792–2000 IU, had a statistically significant 14% reduced rate of any nonvertebral fracture and a significant 30% reduced rate of hip fractures after adjusting for age, gender, and type of dwelling, said Dr. Bischoff-Ferrari, a rheumatologist at the University of Zurich.

Her meta-analysis pooled individual participant data from 12 double-blind, randomized, controlled trials that examined the impact of vitamin D supplements on fracture rate in people aged 65 years or older published through June 2010, and for which she could obtain individual participant data. The primary analysis focused on the 11 studies of the 12 in which participants received the supplement at least monthly, with 31,022 people enrolled. The twelfth study tested once annual dosing, and the researchers included those data in a separate analysis. The participants' average age was 76 years, and about 90% were women.

The analysis divided the study subjects into the control group, with more than 15,000 people, and then into quartiles of their received amount of vitamin D, including both their study-treatment dose and any additional vitamin D intake. The analysis also took into account adherence to treatment. Each vitamin D quartile contained nearly 4,000 people, with a daily dose range of 792–2,000 IU forming the top quartile. Only the top quartile of vitamin intake linked with statistically significant differences, compared with the controls, for any nonvertebral fracture and for hip fracture.

An additional analysis that looked at the interaction of calcium supplements along with vitamin D showed that, with a daily calcium dose below 1,000 mg/day, a high-dose vitamin D supplement (792–2,000 IU/day) linked with a statistically significant reduction in nonvertebral fractures, but when the daily calcium supplement delivered 1,000 mg or more, this amount of vitamin D did not associate with any significant change in fracture rate, suggesting an adverse effect from higher calcium intake.

Vitals

Source ©Joss/Fotolia.com

Major Finding: People taking a calcium supplement showed a statistically significant 24% excess relative risk for MI, a 15% excess relative risk for stroke, and a 16% excess relative risk for MI or stroke.

Data Source: Meta-analysis of nine studies that compared calcium supplements with placebo in a total of more than 28,000 people.

Disclosures: Dr. Reid said that he had no relevant disclosures.

TORONTO — Calcium supplements appear to cause more harm than good, according to a meta-analysis of 28,000 participants in nine trials that includes a new analysis of more than 16,000 participants in the Women's Health Initiative, but the reanalysis has raised concerns among the WHI's original investigators.

“We calculate that for every 1,000 people treated with calcium for 5 years, it will lead to four additional myocardial infarctions, four additional strokes, and two additional deaths, while preventing three fractures,” Dr. Ian R. Reid said.

“I don't prescribe calcium supplements to anyone anymore for preventing bone fractures. People should get calcium from their diet,” said Dr. Reid of the University of Auckland, New Zealand. He speculated that a calcium supplement, even at a relatively modest dose of 500 mg, produces a “borderline hypercalcemia” that persists for several hours and raises the risk for MI or stroke, the same way that people in the highest quartile for normal blood calcium levels have an increased risk for cardiovascular disease events.

But the researchers who ran the Women's Health Initiative (WHI) study questioned the legitimacy of the new analysis beyond a hypothesis-generating exercise.

“The WHI investigators have concerns about the reanalysis and whether omitting the subgroups with favorable results is appropriate,” said Dr. JoAnn E. Manson of Harvard University and Brigham and Women's Hospital, both in Boston, and a WHI coinvestigator.

Dr. Reid and his associates initially reported that calcium supplement use was linked with a statistically significant 27% and 31% relatively increased risk for MI in two separate meta-analyses published online last July (BMJ 2010;341:c3691).

To further explore the impact of calcium supplements on cardiovascular risk, they reanalyzed data collected in a WHI study of more than 36,000 postmenopausal women randomized to receive a daily supplement with 500 mg calcium plus vitamin D or placebo. The original report from the WHI investigators showed that the calcium plus vitamin D did not significantly increase or decrease coronary or cerebrovascular risk in generally healthy postmenopausal women during 7 years of treatment (Circulation 2007;115:846–54).

But at baseline, more than 19,000 (54%) of the women in the study reported using a calcium supplement on their own, and at the end of the study 69% reported the practice, Dr. Reid said. To address the possible confounding, he focused on the 16,718 women in the WHI study who reported not using a personal calcium supplement at entry.

In this subgroup, the MI rates ran 2.5% in women randomized to calcium supplements and 2.0% in the placebo arm, a 22% relative increase that was statistically significant. The rate of MI or stroke ran a relative 16% higher among the women taking calcium, which was also statistically significant. The results showed no significant effect of calcium supplementation on stroke rate, Dr. Reid said.

But if Dr. Reid's analysis did not start with a prior hypothesis, this finding can only be considered hypothesis generating, not hypothesis testing, Dr. Manson said in an interview. “Many subgroups were tested in the WHI, and some would be expected to show significant effect modification by chance,” she pointed out.

When data from the WHI subgroup that did not use personal calcium supplements at baseline were added to the meta-analysis, the results showed that those who did take supplements had a 24% relative excess of MIs, a 15% relative excess of stroke, and a 16% relative excess of MI or stroke, Dr. Reid reported.

'I don't prescribe calcium supplements to anyone anymore for preventing bone fractures.'

Source DR. REID

Major Finding: People taking a calcium supplement showed a statistically significant 24% excess relative risk for MI, a 15% excess relative risk for stroke, and a 16% excess relative risk for MI or stroke.

Data Source: Meta-analysis of nine studies that compared calcium supplements with placebo in a total of more than 28,000 people.

Disclosures: Dr. Reid said that he had no relevant disclosures.

TORONTO — Calcium supplements appear to cause more harm than good, according to a meta-analysis of 28,000 participants in nine trials that includes a new analysis of more than 16,000 participants in the Women's Health Initiative, but the reanalysis has raised concerns among the WHI's original investigators.

“We calculate that for every 1,000 people treated with calcium for 5 years, it will lead to four additional myocardial infarctions, four additional strokes, and two additional deaths, while preventing three fractures,” Dr. Ian R. Reid said.

“I don't prescribe calcium supplements to anyone anymore for preventing bone fractures. People should get calcium from their diet,” said Dr. Reid of the University of Auckland, New Zealand. He speculated that a calcium supplement, even at a relatively modest dose of 500 mg, produces a “borderline hypercalcemia” that persists for several hours and raises the risk for MI or stroke, the same way that people in the highest quartile for normal blood calcium levels have an increased risk for cardiovascular disease events.

But the researchers who ran the Women's Health Initiative (WHI) study questioned the legitimacy of the new analysis beyond a hypothesis-generating exercise.

“The WHI investigators have concerns about the reanalysis and whether omitting the subgroups with favorable results is appropriate,” said Dr. JoAnn E. Manson of Harvard University and Brigham and Women's Hospital, both in Boston, and a WHI coinvestigator.

Dr. Reid and his associates initially reported that calcium supplement use was linked with a statistically significant 27% and 31% relatively increased risk for MI in two separate meta-analyses published online last July (BMJ 2010;341:c3691).

To further explore the impact of calcium supplements on cardiovascular risk, they reanalyzed data collected in a WHI study of more than 36,000 postmenopausal women randomized to receive a daily supplement with 500 mg calcium plus vitamin D or placebo. The original report from the WHI investigators showed that the calcium plus vitamin D did not significantly increase or decrease coronary or cerebrovascular risk in generally healthy postmenopausal women during 7 years of treatment (Circulation 2007;115:846–54).

But at baseline, more than 19,000 (54%) of the women in the study reported using a calcium supplement on their own, and at the end of the study 69% reported the practice, Dr. Reid said. To address the possible confounding, he focused on the 16,718 women in the WHI study who reported not using a personal calcium supplement at entry.

In this subgroup, the MI rates ran 2.5% in women randomized to calcium supplements and 2.0% in the placebo arm, a 22% relative increase that was statistically significant. The rate of MI or stroke ran a relative 16% higher among the women taking calcium, which was also statistically significant. The results showed no significant effect of calcium supplementation on stroke rate, Dr. Reid said.

But if Dr. Reid's analysis did not start with a prior hypothesis, this finding can only be considered hypothesis generating, not hypothesis testing, Dr. Manson said in an interview. “Many subgroups were tested in the WHI, and some would be expected to show significant effect modification by chance,” she pointed out.

When data from the WHI subgroup that did not use personal calcium supplements at baseline were added to the meta-analysis, the results showed that those who did take supplements had a 24% relative excess of MIs, a 15% relative excess of stroke, and a 16% relative excess of MI or stroke, Dr. Reid reported.

'I don't prescribe calcium supplements to anyone anymore for preventing bone fractures.'

Source DR. REID

Major Finding: People taking a calcium supplement showed a statistically significant 24% excess relative risk for MI, a 15% excess relative risk for stroke, and a 16% excess relative risk for MI or stroke.

Data Source: Meta-analysis of nine studies that compared calcium supplements with placebo in a total of more than 28,000 people.

Disclosures: Dr. Reid said that he had no relevant disclosures.

TORONTO — Calcium supplements appear to cause more harm than good, according to a meta-analysis of 28,000 participants in nine trials that includes a new analysis of more than 16,000 participants in the Women's Health Initiative, but the reanalysis has raised concerns among the WHI's original investigators.

“We calculate that for every 1,000 people treated with calcium for 5 years, it will lead to four additional myocardial infarctions, four additional strokes, and two additional deaths, while preventing three fractures,” Dr. Ian R. Reid said.

“I don't prescribe calcium supplements to anyone anymore for preventing bone fractures. People should get calcium from their diet,” said Dr. Reid of the University of Auckland, New Zealand. He speculated that a calcium supplement, even at a relatively modest dose of 500 mg, produces a “borderline hypercalcemia” that persists for several hours and raises the risk for MI or stroke, the same way that people in the highest quartile for normal blood calcium levels have an increased risk for cardiovascular disease events.

But the researchers who ran the Women's Health Initiative (WHI) study questioned the legitimacy of the new analysis beyond a hypothesis-generating exercise.

“The WHI investigators have concerns about the reanalysis and whether omitting the subgroups with favorable results is appropriate,” said Dr. JoAnn E. Manson of Harvard University and Brigham and Women's Hospital, both in Boston, and a WHI coinvestigator.

Dr. Reid and his associates initially reported that calcium supplement use was linked with a statistically significant 27% and 31% relatively increased risk for MI in two separate meta-analyses published online last July (BMJ 2010;341:c3691).

To further explore the impact of calcium supplements on cardiovascular risk, they reanalyzed data collected in a WHI study of more than 36,000 postmenopausal women randomized to receive a daily supplement with 500 mg calcium plus vitamin D or placebo. The original report from the WHI investigators showed that the calcium plus vitamin D did not significantly increase or decrease coronary or cerebrovascular risk in generally healthy postmenopausal women during 7 years of treatment (Circulation 2007;115:846–54).

But at baseline, more than 19,000 (54%) of the women in the study reported using a calcium supplement on their own, and at the end of the study 69% reported the practice, Dr. Reid said. To address the possible confounding, he focused on the 16,718 women in the WHI study who reported not using a personal calcium supplement at entry.

In this subgroup, the MI rates ran 2.5% in women randomized to calcium supplements and 2.0% in the placebo arm, a 22% relative increase that was statistically significant. The rate of MI or stroke ran a relative 16% higher among the women taking calcium, which was also statistically significant. The results showed no significant effect of calcium supplementation on stroke rate, Dr. Reid said.

But if Dr. Reid's analysis did not start with a prior hypothesis, this finding can only be considered hypothesis generating, not hypothesis testing, Dr. Manson said in an interview. “Many subgroups were tested in the WHI, and some would be expected to show significant effect modification by chance,” she pointed out.

When data from the WHI subgroup that did not use personal calcium supplements at baseline were added to the meta-analysis, the results showed that those who did take supplements had a 24% relative excess of MIs, a 15% relative excess of stroke, and a 16% relative excess of MI or stroke, Dr. Reid reported.

'I don't prescribe calcium supplements to anyone anymore for preventing bone fractures.'

Source DR. REID

Major Finding: On average, 50 atypical fractures occurred for every 100,000 patients treated for 5 years, 100 atypical fractures occurred per 100,000 patients treated for 6 years, and almost 250 atypical fractures occurred per 100,000 patients treated for 12 years.

Data Source: Review of radiographs from 1,448 Kaiser California patients with a diaphyseal femur fracture, including 135 that met the atypical criteria.

Disclosures: Dr. Ott, Dr. Wang, and Dr. Ng had no disclosures. Dr. Shane has been a consultant to Amgen and has received research support from Merck, Novartis, and Eli Lilly & Co.

TORONTO — Patients with osteoporosis who are on bisphosphonate therapy clearly face an increased treatment-linked risk for an atypical femur fracture, but at a low rate that is dwarfed by the number of typical hip fractures the drugs prevent.

The risk for atypical fracture appears to rise substantially as time on the drug increases, but an atypical fracture can occur at any time, prompting experts to stress that a bisphosphonate should be given only to a patient who needs the treatment. And the prodromal thigh or groin pain that precedes a majority of atypical fractures should alert physicians to stop bisphosphonate treatment, although stopping the drug is no guarantee against a subsequent atypical fracture.

Above all, experts agreed, atypical fracture risk is no reason to deny bisphosphonate treatment to patients who need it, because these drugs improve bone mineral density and prevent typical hip fractures, and because in appropriate patients this benefit far exceeds the atypical fracture risk.

This consensus on how to view bisphosphonates and their risk for causing atypical fractures pervaded the meeting One multispeaker session during the meeting reviewed the data compiled by and the recommendations from an ASBMR task force that were published online last month, while several other speakers reported some of the incidence data that task force members considered when writing their recommendations (J. Bone Miner. Res. 2010 Oct. 25 [doi:10.1002/jbmr.253]).

“The message is that for patients with osteoporosis at high risk of having a fracture, treatment with a bisphosphonate will benefit far more that the risk for an atypical fractures,” said Dr. Elizabeth Shane, a professor of medicine at Columbia University in New York, and co-chair of the task force.

The largest and most comprehensive look at atypical fracture rates came from data compiled from the 2.6 million beneficiaries older than 45 years enrolled in Kaiser California. During January 2007-December 2009, 15,819 people had femur fractures, excluding those from major trauma, those secondary to Paget's disease or metastatic lesions, or periprosthetic fractures. The researchers reviewed the radiographs for 1,448 of these fractures located in the diaphyseal region.

Of the reviewed fractures, the researchers identified 135 as atypical, Dr. Susan Ott of the University of Washington, Seattle, reported at the meeting. The 135 patients with atypical fractures were 98% women, with an average age of 71 years and an average body mass index of 26.6 kg/m

All but 4% of the atypical fracture patients received a bisphosphonate at the time of fracture, and were on their regimen for an average of 6 years. Two-thirds had prodromal thigh pain, and 26% had bilateral atypical fractures. In all, 60% of the fractures occurred in the femur shaft, and 40% were in the subtrochanteric region.

The most common age at fracture was 65–69 years, with a majority of atypical fracture patients aged 65 or older. The fracture rate rose steadily with increasing years of bisphosphonate use, with most fractures occurring in patients who had used the drugs for at least 5 years, even though these long-term users represented a small minority of all Kaiser patients who used a bisphosphonate during the 3 years studied. The number of fractures per 100,000 people exposed rose steadily with increasing years of use, reaching 50 per 100,000 when bisphosphonate use continued for 5 years and 100 fractures per 100,000 patients in those using the drug for 6 years, and then continuing to rise steadily with added years of use, reaching a high of nearly 250 fractures for every 100,000 patients exposed to a bisphosphonate for 12 years.

“These data do not suggest you should stop using bisphosphonates, especially in women with osteoporosis. Bisphosphonates look pretty safe for the first few years,” Dr. Ott said. But, she added, “the data argue that if a patient does not have osteoporosis, then bisphosphonates are not the appropriate drug.”

The ASBMR task force reviewed Dr. Ott's data before issuing its recommendations last month. The data “were very informative for establishing incidence rates for these fractures,” Dr. Shane said in an interview.

In another talk at the meeting, John Wang, Ph.D., a statistician at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, presented additional data documenting the relative risks of atypical and typical fractures with bisphosphonate treatment.

Patients taking a bisphosphonate face a risk of about 1 additional subtrochanteric hip fracture for every 100 typical hip fractures prevented, according to an analysis of national data during 1996–2007. The new data present no direct evidence for a role of bisphosphonate use in causing subtrochanteric hip fractures, which along with femoral shaft fractures constitute the “atypical” category. But the temporal link between the steady increase in bisphosphonate use among elderly American women during 1996–2007 and the concurrent rise in subtrochanteric fractures also in elderly American women strongly suggests that a causal link exists, Dr. Wang said.

He analyzed data on U.S. subtrochanteric fracture rates from the Nationwide Inpatient Sample from 1996 to 2007, along with data on U.S. bisphosphonate use from the Medical Expenditure Panel Survey. The analysis suggested that bisphosphonate use led to one subtrochanteric fracture for every 100 typical hip fractures prevented, Dr. Wang said, which was similar to the relationship in Dr. Ott's data.

“We have shown a temporal relationship; one precedes the other,” Dr. Wang said in an interview. “That is the first step in showing a causal relationship.” Proof would require a prospective study of atypical fracture incidence in highly compliant patients, he said.

Dr. John Wang discusses data on subtrochanteric femoral fractures in an interview at

Source Mitchel L. Zoler/Elsevier Global Medical Newswww.rheumatologynews.com

Recommended Steps to Minimize Risk

Despite substantial evidence linking long-term bisphosphonate use and an increased rate of atypical femur fractures, bisphosphonates remain an effective and attractive drug class for treating osteoporosis.

The task force assembled by the ASBMR recommended several steps for physicians to take when they prescribe a bisphosphonate to reduce atypical fracture risk.

Patients with a low absolute fracture risk should not receive a bisphosphonate, said Dr. Peter R. Ebeling, a task force member, summarizing the group's recommendations at the meeting.

Patients with secondary causes of rapid bone loss may not need long-term bisphosphonate treatment. Continued use beyond 5 years should be evaluated annually, said Dr. Ebeling of the University of Melbourne.

Patients without a recent fracture and with a femoral neck T score of more than −2.5 after 5 years of continuous bisphosphonate treatment should receive consideration for a drug holiday. Patients taken off bisphosphonate treatment should undergo an annual assessment of their clinical status, markers of bone turnover, bone density, and their fracture risk.

Because a majority of patients who developed an atypical fracture on bisphosphonate treatment had prodromal pain in their thigh or groin, physicians should alert patients to watch for and promptly report such pain. When suspicious pain occurs, the patient needs “urgent” radiographic assessment of both femora, even for unilateral pain, Dr. Ebeling said. If the radiographs appear normal, perform a follow-up examination by MRI or radionuclide scintigraphy scanning.

If a patient has a fracture while on a bisphosphonate, treatment with the bisphosphonate or any other potent antiresorptive drug should stop. At that time, assess the patient's calcium and vitamin D status and prescribe adequate supplementation if needed. The physician should consider prescribing teriparatide to improve fracture healing, particularly if it appears that the fracture has not healed by 4–6 weeks following surgical repair.

Dr. Ebeling has served as a speaker for Merck & Co., Eli Lilly, Novartis, and Sanofi-Aventis; been on advisory boards for and received research grants from Merck, Amgen, and Novartis; and received educational grants from Amgen, Eli Lilly, and Sanofi-Aventis.

Physicians should alert patients to watch for and promptly report prodromal pain in their thigh or groin.

Source DR. EBELING

Major Finding: On average, 50 atypical fractures occurred for every 100,000 patients treated for 5 years, 100 atypical fractures occurred per 100,000 patients treated for 6 years, and almost 250 atypical fractures occurred per 100,000 patients treated for 12 years.

Data Source: Review of radiographs from 1,448 Kaiser California patients with a diaphyseal femur fracture, including 135 that met the atypical criteria.

Disclosures: Dr. Ott, Dr. Wang, and Dr. Ng had no disclosures. Dr. Shane has been a consultant to Amgen and has received research support from Merck, Novartis, and Eli Lilly & Co.

TORONTO — Patients with osteoporosis who are on bisphosphonate therapy clearly face an increased treatment-linked risk for an atypical femur fracture, but at a low rate that is dwarfed by the number of typical hip fractures the drugs prevent.

The risk for atypical fracture appears to rise substantially as time on the drug increases, but an atypical fracture can occur at any time, prompting experts to stress that a bisphosphonate should be given only to a patient who needs the treatment. And the prodromal thigh or groin pain that precedes a majority of atypical fractures should alert physicians to stop bisphosphonate treatment, although stopping the drug is no guarantee against a subsequent atypical fracture.

Above all, experts agreed, atypical fracture risk is no reason to deny bisphosphonate treatment to patients who need it, because these drugs improve bone mineral density and prevent typical hip fractures, and because in appropriate patients this benefit far exceeds the atypical fracture risk.

This consensus on how to view bisphosphonates and their risk for causing atypical fractures pervaded the meeting One multispeaker session during the meeting reviewed the data compiled by and the recommendations from an ASBMR task force that were published online last month, while several other speakers reported some of the incidence data that task force members considered when writing their recommendations (J. Bone Miner. Res. 2010 Oct. 25 [doi:10.1002/jbmr.253]).

“The message is that for patients with osteoporosis at high risk of having a fracture, treatment with a bisphosphonate will benefit far more that the risk for an atypical fractures,” said Dr. Elizabeth Shane, a professor of medicine at Columbia University in New York, and co-chair of the task force.

The largest and most comprehensive look at atypical fracture rates came from data compiled from the 2.6 million beneficiaries older than 45 years enrolled in Kaiser California. During January 2007-December 2009, 15,819 people had femur fractures, excluding those from major trauma, those secondary to Paget's disease or metastatic lesions, or periprosthetic fractures. The researchers reviewed the radiographs for 1,448 of these fractures located in the diaphyseal region.

Of the reviewed fractures, the researchers identified 135 as atypical, Dr. Susan Ott of the University of Washington, Seattle, reported at the meeting. The 135 patients with atypical fractures were 98% women, with an average age of 71 years and an average body mass index of 26.6 kg/m

All but 4% of the atypical fracture patients received a bisphosphonate at the time of fracture, and were on their regimen for an average of 6 years. Two-thirds had prodromal thigh pain, and 26% had bilateral atypical fractures. In all, 60% of the fractures occurred in the femur shaft, and 40% were in the subtrochanteric region.

The most common age at fracture was 65–69 years, with a majority of atypical fracture patients aged 65 or older. The fracture rate rose steadily with increasing years of bisphosphonate use, with most fractures occurring in patients who had used the drugs for at least 5 years, even though these long-term users represented a small minority of all Kaiser patients who used a bisphosphonate during the 3 years studied. The number of fractures per 100,000 people exposed rose steadily with increasing years of use, reaching 50 per 100,000 when bisphosphonate use continued for 5 years and 100 fractures per 100,000 patients in those using the drug for 6 years, and then continuing to rise steadily with added years of use, reaching a high of nearly 250 fractures for every 100,000 patients exposed to a bisphosphonate for 12 years.

“These data do not suggest you should stop using bisphosphonates, especially in women with osteoporosis. Bisphosphonates look pretty safe for the first few years,” Dr. Ott said. But, she added, “the data argue that if a patient does not have osteoporosis, then bisphosphonates are not the appropriate drug.”

The ASBMR task force reviewed Dr. Ott's data before issuing its recommendations last month. The data “were very informative for establishing incidence rates for these fractures,” Dr. Shane said in an interview.

In another talk at the meeting, John Wang, Ph.D., a statistician at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, presented additional data documenting the relative risks of atypical and typical fractures with bisphosphonate treatment.

Patients taking a bisphosphonate face a risk of about 1 additional subtrochanteric hip fracture for every 100 typical hip fractures prevented, according to an analysis of national data during 1996–2007. The new data present no direct evidence for a role of bisphosphonate use in causing subtrochanteric hip fractures, which along with femoral shaft fractures constitute the “atypical” category. But the temporal link between the steady increase in bisphosphonate use among elderly American women during 1996–2007 and the concurrent rise in subtrochanteric fractures also in elderly American women strongly suggests that a causal link exists, Dr. Wang said.

He analyzed data on U.S. subtrochanteric fracture rates from the Nationwide Inpatient Sample from 1996 to 2007, along with data on U.S. bisphosphonate use from the Medical Expenditure Panel Survey. The analysis suggested that bisphosphonate use led to one subtrochanteric fracture for every 100 typical hip fractures prevented, Dr. Wang said, which was similar to the relationship in Dr. Ott's data.

“We have shown a temporal relationship; one precedes the other,” Dr. Wang said in an interview. “That is the first step in showing a causal relationship.” Proof would require a prospective study of atypical fracture incidence in highly compliant patients, he said.

Dr. John Wang discusses data on subtrochanteric femoral fractures in an interview at

Source Mitchel L. Zoler/Elsevier Global Medical Newswww.rheumatologynews.com

Recommended Steps to Minimize Risk

Despite substantial evidence linking long-term bisphosphonate use and an increased rate of atypical femur fractures, bisphosphonates remain an effective and attractive drug class for treating osteoporosis.

The task force assembled by the ASBMR recommended several steps for physicians to take when they prescribe a bisphosphonate to reduce atypical fracture risk.

Patients with a low absolute fracture risk should not receive a bisphosphonate, said Dr. Peter R. Ebeling, a task force member, summarizing the group's recommendations at the meeting.

Patients with secondary causes of rapid bone loss may not need long-term bisphosphonate treatment. Continued use beyond 5 years should be evaluated annually, said Dr. Ebeling of the University of Melbourne.

Patients without a recent fracture and with a femoral neck T score of more than −2.5 after 5 years of continuous bisphosphonate treatment should receive consideration for a drug holiday. Patients taken off bisphosphonate treatment should undergo an annual assessment of their clinical status, markers of bone turnover, bone density, and their fracture risk.

Because a majority of patients who developed an atypical fracture on bisphosphonate treatment had prodromal pain in their thigh or groin, physicians should alert patients to watch for and promptly report such pain. When suspicious pain occurs, the patient needs “urgent” radiographic assessment of both femora, even for unilateral pain, Dr. Ebeling said. If the radiographs appear normal, perform a follow-up examination by MRI or radionuclide scintigraphy scanning.

If a patient has a fracture while on a bisphosphonate, treatment with the bisphosphonate or any other potent antiresorptive drug should stop. At that time, assess the patient's calcium and vitamin D status and prescribe adequate supplementation if needed. The physician should consider prescribing teriparatide to improve fracture healing, particularly if it appears that the fracture has not healed by 4–6 weeks following surgical repair.

Dr. Ebeling has served as a speaker for Merck & Co., Eli Lilly, Novartis, and Sanofi-Aventis; been on advisory boards for and received research grants from Merck, Amgen, and Novartis; and received educational grants from Amgen, Eli Lilly, and Sanofi-Aventis.

Physicians should alert patients to watch for and promptly report prodromal pain in their thigh or groin.

Source DR. EBELING

Major Finding: On average, 50 atypical fractures occurred for every 100,000 patients treated for 5 years, 100 atypical fractures occurred per 100,000 patients treated for 6 years, and almost 250 atypical fractures occurred per 100,000 patients treated for 12 years.

Data Source: Review of radiographs from 1,448 Kaiser California patients with a diaphyseal femur fracture, including 135 that met the atypical criteria.

Disclosures: Dr. Ott, Dr. Wang, and Dr. Ng had no disclosures. Dr. Shane has been a consultant to Amgen and has received research support from Merck, Novartis, and Eli Lilly & Co.

TORONTO — Patients with osteoporosis who are on bisphosphonate therapy clearly face an increased treatment-linked risk for an atypical femur fracture, but at a low rate that is dwarfed by the number of typical hip fractures the drugs prevent.

The risk for atypical fracture appears to rise substantially as time on the drug increases, but an atypical fracture can occur at any time, prompting experts to stress that a bisphosphonate should be given only to a patient who needs the treatment. And the prodromal thigh or groin pain that precedes a majority of atypical fractures should alert physicians to stop bisphosphonate treatment, although stopping the drug is no guarantee against a subsequent atypical fracture.

Above all, experts agreed, atypical fracture risk is no reason to deny bisphosphonate treatment to patients who need it, because these drugs improve bone mineral density and prevent typical hip fractures, and because in appropriate patients this benefit far exceeds the atypical fracture risk.

This consensus on how to view bisphosphonates and their risk for causing atypical fractures pervaded the meeting One multispeaker session during the meeting reviewed the data compiled by and the recommendations from an ASBMR task force that were published online last month, while several other speakers reported some of the incidence data that task force members considered when writing their recommendations (J. Bone Miner. Res. 2010 Oct. 25 [doi:10.1002/jbmr.253]).

“The message is that for patients with osteoporosis at high risk of having a fracture, treatment with a bisphosphonate will benefit far more that the risk for an atypical fractures,” said Dr. Elizabeth Shane, a professor of medicine at Columbia University in New York, and co-chair of the task force.

The largest and most comprehensive look at atypical fracture rates came from data compiled from the 2.6 million beneficiaries older than 45 years enrolled in Kaiser California. During January 2007-December 2009, 15,819 people had femur fractures, excluding those from major trauma, those secondary to Paget's disease or metastatic lesions, or periprosthetic fractures. The researchers reviewed the radiographs for 1,448 of these fractures located in the diaphyseal region.

Of the reviewed fractures, the researchers identified 135 as atypical, Dr. Susan Ott of the University of Washington, Seattle, reported at the meeting. The 135 patients with atypical fractures were 98% women, with an average age of 71 years and an average body mass index of 26.6 kg/m

All but 4% of the atypical fracture patients received a bisphosphonate at the time of fracture, and were on their regimen for an average of 6 years. Two-thirds had prodromal thigh pain, and 26% had bilateral atypical fractures. In all, 60% of the fractures occurred in the femur shaft, and 40% were in the subtrochanteric region.

The most common age at fracture was 65–69 years, with a majority of atypical fracture patients aged 65 or older. The fracture rate rose steadily with increasing years of bisphosphonate use, with most fractures occurring in patients who had used the drugs for at least 5 years, even though these long-term users represented a small minority of all Kaiser patients who used a bisphosphonate during the 3 years studied. The number of fractures per 100,000 people exposed rose steadily with increasing years of use, reaching 50 per 100,000 when bisphosphonate use continued for 5 years and 100 fractures per 100,000 patients in those using the drug for 6 years, and then continuing to rise steadily with added years of use, reaching a high of nearly 250 fractures for every 100,000 patients exposed to a bisphosphonate for 12 years.

“These data do not suggest you should stop using bisphosphonates, especially in women with osteoporosis. Bisphosphonates look pretty safe for the first few years,” Dr. Ott said. But, she added, “the data argue that if a patient does not have osteoporosis, then bisphosphonates are not the appropriate drug.”

The ASBMR task force reviewed Dr. Ott's data before issuing its recommendations last month. The data “were very informative for establishing incidence rates for these fractures,” Dr. Shane said in an interview.

In another talk at the meeting, John Wang, Ph.D., a statistician at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, presented additional data documenting the relative risks of atypical and typical fractures with bisphosphonate treatment.

Patients taking a bisphosphonate face a risk of about 1 additional subtrochanteric hip fracture for every 100 typical hip fractures prevented, according to an analysis of national data during 1996–2007. The new data present no direct evidence for a role of bisphosphonate use in causing subtrochanteric hip fractures, which along with femoral shaft fractures constitute the “atypical” category. But the temporal link between the steady increase in bisphosphonate use among elderly American women during 1996–2007 and the concurrent rise in subtrochanteric fractures also in elderly American women strongly suggests that a causal link exists, Dr. Wang said.

He analyzed data on U.S. subtrochanteric fracture rates from the Nationwide Inpatient Sample from 1996 to 2007, along with data on U.S. bisphosphonate use from the Medical Expenditure Panel Survey. The analysis suggested that bisphosphonate use led to one subtrochanteric fracture for every 100 typical hip fractures prevented, Dr. Wang said, which was similar to the relationship in Dr. Ott's data.

“We have shown a temporal relationship; one precedes the other,” Dr. Wang said in an interview. “That is the first step in showing a causal relationship.” Proof would require a prospective study of atypical fracture incidence in highly compliant patients, he said.

Dr. John Wang discusses data on subtrochanteric femoral fractures in an interview at

Source Mitchel L. Zoler/Elsevier Global Medical Newswww.rheumatologynews.com

Recommended Steps to Minimize Risk

Despite substantial evidence linking long-term bisphosphonate use and an increased rate of atypical femur fractures, bisphosphonates remain an effective and attractive drug class for treating osteoporosis.

The task force assembled by the ASBMR recommended several steps for physicians to take when they prescribe a bisphosphonate to reduce atypical fracture risk.

Patients with a low absolute fracture risk should not receive a bisphosphonate, said Dr. Peter R. Ebeling, a task force member, summarizing the group's recommendations at the meeting.

Patients with secondary causes of rapid bone loss may not need long-term bisphosphonate treatment. Continued use beyond 5 years should be evaluated annually, said Dr. Ebeling of the University of Melbourne.

Patients without a recent fracture and with a femoral neck T score of more than −2.5 after 5 years of continuous bisphosphonate treatment should receive consideration for a drug holiday. Patients taken off bisphosphonate treatment should undergo an annual assessment of their clinical status, markers of bone turnover, bone density, and their fracture risk.

Because a majority of patients who developed an atypical fracture on bisphosphonate treatment had prodromal pain in their thigh or groin, physicians should alert patients to watch for and promptly report such pain. When suspicious pain occurs, the patient needs “urgent” radiographic assessment of both femora, even for unilateral pain, Dr. Ebeling said. If the radiographs appear normal, perform a follow-up examination by MRI or radionuclide scintigraphy scanning.

If a patient has a fracture while on a bisphosphonate, treatment with the bisphosphonate or any other potent antiresorptive drug should stop. At that time, assess the patient's calcium and vitamin D status and prescribe adequate supplementation if needed. The physician should consider prescribing teriparatide to improve fracture healing, particularly if it appears that the fracture has not healed by 4–6 weeks following surgical repair.

Dr. Ebeling has served as a speaker for Merck & Co., Eli Lilly, Novartis, and Sanofi-Aventis; been on advisory boards for and received research grants from Merck, Amgen, and Novartis; and received educational grants from Amgen, Eli Lilly, and Sanofi-Aventis.

Physicians should alert patients to watch for and promptly report prodromal pain in their thigh or groin.

Source DR. EBELING

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 on the recommendations in 2008, and the proposed revisions – based on consensus of the panel – 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, Carol Oatis, Ph.D., reported at the annual meeting of the American College of Rheumatology.

Photo (c)Elena Korenbaum/ iStockphoto.com

As such, the panel proposes to recommend these treatments, said Dr. Oatis, a physical therapist and professor of physical therapy at Arcadia University in Glenside, Pa., and a member of the technical expert panel.

This was the only time the panel deemed supporting evidence to be "strong." They did so based on the GRADE methodology used in developing the revised recommendations. GRADE (grades of recommendations, assessment, development, and evaluation) allows for rating of the available evidence as "strong," "weak," or "none." The GRADE working group developed the system for evaluating data supporting recommendation in health care in 2000.

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.

The panel "recommends" modalities with strong evidence, "suggests" those with weak evidence, and provides "no guidance" for those in the "none" category.

Weak evidence of benefit in hip OA was found for manual therapy in combination with supervised exercise programs, therefore 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:

• 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 (CMC joint at the base of the thumb).

Thus, the panel "suggests" use of these modalities, said Catherine Backman, Ph.D., an occupational therapist and faculty member 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, and discuss the evidence with patients in relation to their values and preferences," she said.

No other recommendations or suggestions were made for hand OA.

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

• 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 and faculty member 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, professor and 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.

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 on the recommendations in 2008, and the proposed revisions – based on consensus of the panel – 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, Carol Oatis, Ph.D., reported at the annual meeting of the American College of Rheumatology.

Photo (c)Elena Korenbaum/ iStockphoto.com

As such, the panel proposes to recommend these treatments, said Dr. Oatis, a physical therapist and professor of physical therapy at Arcadia University in Glenside, Pa., and a member of the technical expert panel.

This was the only time the panel deemed supporting evidence to be "strong." They did so based on the GRADE methodology used in developing the revised recommendations. GRADE (grades of recommendations, assessment, development, and evaluation) allows for rating of the available evidence as "strong," "weak," or "none." The GRADE working group developed the system for evaluating data supporting recommendation in health care in 2000.

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.

The panel "recommends" modalities with strong evidence, "suggests" those with weak evidence, and provides "no guidance" for those in the "none" category.

Weak evidence of benefit in hip OA was found for manual therapy in combination with supervised exercise programs, therefore 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:

• 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 (CMC joint at the base of the thumb).

Thus, the panel "suggests" use of these modalities, said Catherine Backman, Ph.D., an occupational therapist and faculty member 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, and discuss the evidence with patients in relation to their values and preferences," she said.

No other recommendations or suggestions were made for hand OA.

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

• 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 and faculty member 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, professor and 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.

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 on the recommendations in 2008, and the proposed revisions – based on consensus of the panel – 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, Carol Oatis, Ph.D., reported at the annual meeting of the American College of Rheumatology.

Photo (c)Elena Korenbaum/ iStockphoto.com

As such, the panel proposes to recommend these treatments, said Dr. Oatis, a physical therapist and professor of physical therapy at Arcadia University in Glenside, Pa., and a member of the technical expert panel.

This was the only time the panel deemed supporting evidence to be "strong." They did so based on the GRADE methodology used in developing the revised recommendations. GRADE (grades of recommendations, assessment, development, and evaluation) allows for rating of the available evidence as "strong," "weak," or "none." The GRADE working group developed the system for evaluating data supporting recommendation in health care in 2000.

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.

The panel "recommends" modalities with strong evidence, "suggests" those with weak evidence, and provides "no guidance" for those in the "none" category.

Weak evidence of benefit in hip OA was found for manual therapy in combination with supervised exercise programs, therefore 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:

• 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 (CMC joint at the base of the thumb).

Thus, the panel "suggests" use of these modalities, said Catherine Backman, Ph.D., an occupational therapist and faculty member 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, and discuss the evidence with patients in relation to their values and preferences," she said.

No other recommendations or suggestions were made for hand OA.

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

• 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 and faculty member 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, professor and 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.

BRUSSELS – Statin therapy may exert yet another beneficial clinical effect – preventing the development of knee osteoarthritis and slowing its progression – based on an analysis of more than 3,000 people who were enrolled in a prospective cohort study.

In an analysis of people in the Rotterdam Study, statin use was linked with a more-than-50% reduced rate of knee osteoarthritis (OA) incidence, and a more-than-50% reduced rate of knee OA progression after adjustment for baseline risk factors, Dr. Stefan Clockaerts said at the congress. In contrast, statin use had no impact on hip OA.

The findings suggest knee OA may be at least partly a metabolic disease, said Dr. Clockaerts of the orthopedics department at Erasmus University, Rotterdam, the Netherlands, and at the University of Antwerp (Belgium).

“We think that there is a difference in the pathogenesis of hip and knee osteoarthritis, and that several systemic factors – such as cholesterol, body mass index, and diabetes – appear to influence knee osteoarthritis” but not deterioration of the hip, Dr. Clockaerts said in an interview.

Another hypothesis is that vascular pathology may contribute to the OA disease process, and that statins' benefits on atherosclerosis may also link statins and knee OA. The anti-inflammatory effect of statins most likely also plays a role.

The Rotterdam Study began in 1990 and enrolled 7,983 men and women aged 55 years or older into a longitudinal cohort study. The analysis by Dr. Clockaerts and his associates focused on participants with knee and hip x-rays that were available from baseline and follow-up and were evaluable for scoring on the Kellgren-Lawrence (KL) scale.

Information on statin use came from computerized pharmacy records. The analysis considered anyone to be a statin user who received a statin prescription for at least 100 days for at least 50% of the drug's recommended daily dosage.

Among 3,056 people who were evaluable for incident knee OA, statin users had a significant, 57% reduced rate of knee OA, vs. nonusers, after adjustment for baseline age, diabetes, BMI, total cholesterol:HDL cholesterol ratio, and bone mineral density (BMD), said Dr. Clockaerts at the congress, which was presented by the Osteoarthritis Research Society International. (See box.)

Progression of knee OA among 1,412 people with a baseline KL score of 1-3 occurred 53% less often in the statin users, compared with nonusers after adjustment for age, BMI, and BMD, which was a significant difference.

Dr. Clockaerts said that he had no disclosures.

Elsevier Global Medical News

BRUSSELS – Statin therapy may exert yet another beneficial clinical effect – preventing the development of knee osteoarthritis and slowing its progression – based on an analysis of more than 3,000 people who were enrolled in a prospective cohort study.

In an analysis of people in the Rotterdam Study, statin use was linked with a more-than-50% reduced rate of knee osteoarthritis (OA) incidence, and a more-than-50% reduced rate of knee OA progression after adjustment for baseline risk factors, Dr. Stefan Clockaerts said at the congress. In contrast, statin use had no impact on hip OA.

The findings suggest knee OA may be at least partly a metabolic disease, said Dr. Clockaerts of the orthopedics department at Erasmus University, Rotterdam, the Netherlands, and at the University of Antwerp (Belgium).

“We think that there is a difference in the pathogenesis of hip and knee osteoarthritis, and that several systemic factors – such as cholesterol, body mass index, and diabetes – appear to influence knee osteoarthritis” but not deterioration of the hip, Dr. Clockaerts said in an interview.

Another hypothesis is that vascular pathology may contribute to the OA disease process, and that statins' benefits on atherosclerosis may also link statins and knee OA. The anti-inflammatory effect of statins most likely also plays a role.

The Rotterdam Study began in 1990 and enrolled 7,983 men and women aged 55 years or older into a longitudinal cohort study. The analysis by Dr. Clockaerts and his associates focused on participants with knee and hip x-rays that were available from baseline and follow-up and were evaluable for scoring on the Kellgren-Lawrence (KL) scale.

Information on statin use came from computerized pharmacy records. The analysis considered anyone to be a statin user who received a statin prescription for at least 100 days for at least 50% of the drug's recommended daily dosage.

Among 3,056 people who were evaluable for incident knee OA, statin users had a significant, 57% reduced rate of knee OA, vs. nonusers, after adjustment for baseline age, diabetes, BMI, total cholesterol:HDL cholesterol ratio, and bone mineral density (BMD), said Dr. Clockaerts at the congress, which was presented by the Osteoarthritis Research Society International. (See box.)

Progression of knee OA among 1,412 people with a baseline KL score of 1-3 occurred 53% less often in the statin users, compared with nonusers after adjustment for age, BMI, and BMD, which was a significant difference.

Dr. Clockaerts said that he had no disclosures.

Elsevier Global Medical News

BRUSSELS – Statin therapy may exert yet another beneficial clinical effect – preventing the development of knee osteoarthritis and slowing its progression – based on an analysis of more than 3,000 people who were enrolled in a prospective cohort study.

In an analysis of people in the Rotterdam Study, statin use was linked with a more-than-50% reduced rate of knee osteoarthritis (OA) incidence, and a more-than-50% reduced rate of knee OA progression after adjustment for baseline risk factors, Dr. Stefan Clockaerts said at the congress. In contrast, statin use had no impact on hip OA.

The findings suggest knee OA may be at least partly a metabolic disease, said Dr. Clockaerts of the orthopedics department at Erasmus University, Rotterdam, the Netherlands, and at the University of Antwerp (Belgium).

“We think that there is a difference in the pathogenesis of hip and knee osteoarthritis, and that several systemic factors – such as cholesterol, body mass index, and diabetes – appear to influence knee osteoarthritis” but not deterioration of the hip, Dr. Clockaerts said in an interview.

Another hypothesis is that vascular pathology may contribute to the OA disease process, and that statins' benefits on atherosclerosis may also link statins and knee OA. The anti-inflammatory effect of statins most likely also plays a role.

The Rotterdam Study began in 1990 and enrolled 7,983 men and women aged 55 years or older into a longitudinal cohort study. The analysis by Dr. Clockaerts and his associates focused on participants with knee and hip x-rays that were available from baseline and follow-up and were evaluable for scoring on the Kellgren-Lawrence (KL) scale.

Information on statin use came from computerized pharmacy records. The analysis considered anyone to be a statin user who received a statin prescription for at least 100 days for at least 50% of the drug's recommended daily dosage.

Among 3,056 people who were evaluable for incident knee OA, statin users had a significant, 57% reduced rate of knee OA, vs. nonusers, after adjustment for baseline age, diabetes, BMI, total cholesterol:HDL cholesterol ratio, and bone mineral density (BMD), said Dr. Clockaerts at the congress, which was presented by the Osteoarthritis Research Society International. (See box.)

Progression of knee OA among 1,412 people with a baseline KL score of 1-3 occurred 53% less often in the statin users, compared with nonusers after adjustment for age, BMI, and BMD, which was a significant difference.

Dr. Clockaerts said that he had no disclosures.

Elsevier Global Medical News

BRUSSELS – The use of magnetic resonance imaging may enable earlier recognition of knee osteoarthritis, and should be incorporated into recommended diagnostic criteria, a panel of 16 osteoarthritis experts concluded.

Using MRI to define knee osteoarthritis (OA) may allow detection of the disease before radiographic changes occur. But despite a growing body of literature on the role of MRI in OA, little uniformity exists for its diagnostic application, perhaps because of the absence of criteria for an MRI-based structural diagnosis of OA, the group said.

The Osteoarthritis Research Society International (OARSI) organized the 16-member panel, the OA Imaging Working Group, to develop an MRI-based definition of structural OA. The working group sought to identify structural changes on MRI that defined a structural diagnosis of knee OA, Dr. David J. Hunter and the other members of the working group wrote in a poster presented at the congress, which was organized by OARSI.

The working group began with a literature review through April 2009, a process that yielded 25 studies that met the group's inclusion criteria and evaluated MRI diagnostic performance. Through a multiphase process of discussion and voting, the group agreed on a set of nine propositions and two OA definitions based on MRI criteria. (See boxes.) These constitute “statements of preamble and context setting.” The two definitions “offer an opportunity for formal testing against other diagnostic constructs,” said Dr. Hunter, a rheumatologist and professor of medicine at the University of Sydney and his associates in the working group.

The working group noted that the American College of Rheumatology in 1986 first released the current standard criteria for diagnosing OA, which deal only with radiographic imaging (Arthritis Rheum. 1986;29:1039-49). The European League Against Rheumatism published more current recommendations this year, but focused on a clinical diagnosis that did not involve imaging (Ann. Rheum. Dis. 2010;69:483-9).

The working group aimed to “include MRI as a means to define the disease with the intent that one may be able to identify early, preradiographic disease, thus enabling recruitment of study populations where structure modification (or structure maintenance) may be realistic in a more preventive manner.”

The group cautioned that prior to using the definitions, “it is important that their validity and diagnostic performance be adequately tested.” They also stressed that “the propositions have been developed for structural OA, not for a clinical diagnosis, not for early OA, and not to facilitate staging of the disease.”

An osteoarthritis specialist who was not involved with the working group cautioned that waiting for MRI structural changes that are specific for OA may still miss a truly early diagnosis, before irreversible pathology occurred.

“There are early changes [seen with MRI] that are not picked up on radiographs, but we don't yet have a standardized, validated definition of an earlier stage” on MRI, Dr. Tuhina Neogi, a rheumatologist at Boston University, said in an interview.

Dr. Hunter said that he has received research support from AstraZeneca, DJO Inc. (DonJoy), Eli Lilly & Co., Merck & Co., Pfizer Inc., Stryker Corp., and Wyeth. Eight of the other members of the working group also provided disclosures, whereas the remaining seven members said they had no disclosures. Dr. Neogi had no disclosures.

The Panel's MRI-Based Definition of OA

The two definitions of MRI findings diagnostic of knee OA are:

1. Tibiofemoral OA should have either both features from group A (below), or one feature from group A and at least two from group B. Examination of the patient must also rule out joint trauma in the past 6 months (by history) and inflammatory arthritis (by radiographs, history, and lab findings).

▸ Group A features: Definite osteophyte formation; full-thickness cartilage loss.

▸ Group B features: Subchondral bone marrow lesion or cyst not associated with meniscal or ligamentous attachments; meniscal subluxation, maceration, or degenerative (horizontal) tear; partial-thickness cartilage loss (without full-thickness loss).

2. Patellofemoral OA requires both of the following features involving the patella, anterior femur, or both:

▸ Definite osteophyte formation.

▸ Partial- or full-thickness cartilage loss.

The Panel's Propositions

Here are the nine propositions on MRI diagnosis of knee OA:

1. MRI changes of OA may occur in the absence of radiographic findings of OA.

2. MRI may add to the diagnosis of OA and should be incorporated into the ACR diagnostic criteria including x-ray, clinical, and lab parameters.

3. MRI may be used for inclusion in clinical studies, but should not be a primary diagnostic tool in a clinical setting.

4. Certain MRI changes that occur in isolation are not diagnostic of OA, including cartilage loss; change in cartilage composition; cystic change and development of bone marrow lesions; and ligamentous, tendinous, and meniscal damage.

5. No single finding is diagnostic of knee OA.

6. MRI findings indicative of knee OA may include abnormalities in all tissues of the joint (bone, cartilage, meniscus, synovium, ligament, and capsule).

7. Given the multiple tissue abnormalities detected by MRI in OA, diagnostic criteria are likely to involve combinations of features.

8. Definite osteophyte production is indicative of OA.

9. Joint space narrowing as assessed by MRI cannot be used as a diagnostic criterion.

BRUSSELS – The use of magnetic resonance imaging may enable earlier recognition of knee osteoarthritis, and should be incorporated into recommended diagnostic criteria, a panel of 16 osteoarthritis experts concluded.

Using MRI to define knee osteoarthritis (OA) may allow detection of the disease before radiographic changes occur. But despite a growing body of literature on the role of MRI in OA, little uniformity exists for its diagnostic application, perhaps because of the absence of criteria for an MRI-based structural diagnosis of OA, the group said.

The Osteoarthritis Research Society International (OARSI) organized the 16-member panel, the OA Imaging Working Group, to develop an MRI-based definition of structural OA. The working group sought to identify structural changes on MRI that defined a structural diagnosis of knee OA, Dr. David J. Hunter and the other members of the working group wrote in a poster presented at the congress, which was organized by OARSI.

The working group began with a literature review through April 2009, a process that yielded 25 studies that met the group's inclusion criteria and evaluated MRI diagnostic performance. Through a multiphase process of discussion and voting, the group agreed on a set of nine propositions and two OA definitions based on MRI criteria. (See boxes.) These constitute “statements of preamble and context setting.” The two definitions “offer an opportunity for formal testing against other diagnostic constructs,” said Dr. Hunter, a rheumatologist and professor of medicine at the University of Sydney and his associates in the working group.

The working group noted that the American College of Rheumatology in 1986 first released the current standard criteria for diagnosing OA, which deal only with radiographic imaging (Arthritis Rheum. 1986;29:1039-49). The European League Against Rheumatism published more current recommendations this year, but focused on a clinical diagnosis that did not involve imaging (Ann. Rheum. Dis. 2010;69:483-9).

The working group aimed to “include MRI as a means to define the disease with the intent that one may be able to identify early, preradiographic disease, thus enabling recruitment of study populations where structure modification (or structure maintenance) may be realistic in a more preventive manner.”

The group cautioned that prior to using the definitions, “it is important that their validity and diagnostic performance be adequately tested.” They also stressed that “the propositions have been developed for structural OA, not for a clinical diagnosis, not for early OA, and not to facilitate staging of the disease.”

An osteoarthritis specialist who was not involved with the working group cautioned that waiting for MRI structural changes that are specific for OA may still miss a truly early diagnosis, before irreversible pathology occurred.

“There are early changes [seen with MRI] that are not picked up on radiographs, but we don't yet have a standardized, validated definition of an earlier stage” on MRI, Dr. Tuhina Neogi, a rheumatologist at Boston University, said in an interview.

Dr. Hunter said that he has received research support from AstraZeneca, DJO Inc. (DonJoy), Eli Lilly & Co., Merck & Co., Pfizer Inc., Stryker Corp., and Wyeth. Eight of the other members of the working group also provided disclosures, whereas the remaining seven members said they had no disclosures. Dr. Neogi had no disclosures.

The Panel's MRI-Based Definition of OA

The two definitions of MRI findings diagnostic of knee OA are:

1. Tibiofemoral OA should have either both features from group A (below), or one feature from group A and at least two from group B. Examination of the patient must also rule out joint trauma in the past 6 months (by history) and inflammatory arthritis (by radiographs, history, and lab findings).

▸ Group A features: Definite osteophyte formation; full-thickness cartilage loss.

▸ Group B features: Subchondral bone marrow lesion or cyst not associated with meniscal or ligamentous attachments; meniscal subluxation, maceration, or degenerative (horizontal) tear; partial-thickness cartilage loss (without full-thickness loss).

2. Patellofemoral OA requires both of the following features involving the patella, anterior femur, or both:

▸ Definite osteophyte formation.

▸ Partial- or full-thickness cartilage loss.

The Panel's Propositions

Here are the nine propositions on MRI diagnosis of knee OA:

1. MRI changes of OA may occur in the absence of radiographic findings of OA.

2. MRI may add to the diagnosis of OA and should be incorporated into the ACR diagnostic criteria including x-ray, clinical, and lab parameters.

3. MRI may be used for inclusion in clinical studies, but should not be a primary diagnostic tool in a clinical setting.

4. Certain MRI changes that occur in isolation are not diagnostic of OA, including cartilage loss; change in cartilage composition; cystic change and development of bone marrow lesions; and ligamentous, tendinous, and meniscal damage.

5. No single finding is diagnostic of knee OA.

6. MRI findings indicative of knee OA may include abnormalities in all tissues of the joint (bone, cartilage, meniscus, synovium, ligament, and capsule).

7. Given the multiple tissue abnormalities detected by MRI in OA, diagnostic criteria are likely to involve combinations of features.

8. Definite osteophyte production is indicative of OA.

9. Joint space narrowing as assessed by MRI cannot be used as a diagnostic criterion.

BRUSSELS – The use of magnetic resonance imaging may enable earlier recognition of knee osteoarthritis, and should be incorporated into recommended diagnostic criteria, a panel of 16 osteoarthritis experts concluded.

Using MRI to define knee osteoarthritis (OA) may allow detection of the disease before radiographic changes occur. But despite a growing body of literature on the role of MRI in OA, little uniformity exists for its diagnostic application, perhaps because of the absence of criteria for an MRI-based structural diagnosis of OA, the group said.

The Osteoarthritis Research Society International (OARSI) organized the 16-member panel, the OA Imaging Working Group, to develop an MRI-based definition of structural OA. The working group sought to identify structural changes on MRI that defined a structural diagnosis of knee OA, Dr. David J. Hunter and the other members of the working group wrote in a poster presented at the congress, which was organized by OARSI.

The working group began with a literature review through April 2009, a process that yielded 25 studies that met the group's inclusion criteria and evaluated MRI diagnostic performance. Through a multiphase process of discussion and voting, the group agreed on a set of nine propositions and two OA definitions based on MRI criteria. (See boxes.) These constitute “statements of preamble and context setting.” The two definitions “offer an opportunity for formal testing against other diagnostic constructs,” said Dr. Hunter, a rheumatologist and professor of medicine at the University of Sydney and his associates in the working group.

The working group noted that the American College of Rheumatology in 1986 first released the current standard criteria for diagnosing OA, which deal only with radiographic imaging (Arthritis Rheum. 1986;29:1039-49). The European League Against Rheumatism published more current recommendations this year, but focused on a clinical diagnosis that did not involve imaging (Ann. Rheum. Dis. 2010;69:483-9).

The working group aimed to “include MRI as a means to define the disease with the intent that one may be able to identify early, preradiographic disease, thus enabling recruitment of study populations where structure modification (or structure maintenance) may be realistic in a more preventive manner.”

The group cautioned that prior to using the definitions, “it is important that their validity and diagnostic performance be adequately tested.” They also stressed that “the propositions have been developed for structural OA, not for a clinical diagnosis, not for early OA, and not to facilitate staging of the disease.”

An osteoarthritis specialist who was not involved with the working group cautioned that waiting for MRI structural changes that are specific for OA may still miss a truly early diagnosis, before irreversible pathology occurred.

“There are early changes [seen with MRI] that are not picked up on radiographs, but we don't yet have a standardized, validated definition of an earlier stage” on MRI, Dr. Tuhina Neogi, a rheumatologist at Boston University, said in an interview.

Dr. Hunter said that he has received research support from AstraZeneca, DJO Inc. (DonJoy), Eli Lilly & Co., Merck & Co., Pfizer Inc., Stryker Corp., and Wyeth. Eight of the other members of the working group also provided disclosures, whereas the remaining seven members said they had no disclosures. Dr. Neogi had no disclosures.

The Panel's MRI-Based Definition of OA

The two definitions of MRI findings diagnostic of knee OA are:

1. Tibiofemoral OA should have either both features from group A (below), or one feature from group A and at least two from group B. Examination of the patient must also rule out joint trauma in the past 6 months (by history) and inflammatory arthritis (by radiographs, history, and lab findings).

▸ Group A features: Definite osteophyte formation; full-thickness cartilage loss.

▸ Group B features: Subchondral bone marrow lesion or cyst not associated with meniscal or ligamentous attachments; meniscal subluxation, maceration, or degenerative (horizontal) tear; partial-thickness cartilage loss (without full-thickness loss).

2. Patellofemoral OA requires both of the following features involving the patella, anterior femur, or both:

▸ Definite osteophyte formation.

▸ Partial- or full-thickness cartilage loss.

The Panel's Propositions

Here are the nine propositions on MRI diagnosis of knee OA:

1. MRI changes of OA may occur in the absence of radiographic findings of OA.

2. MRI may add to the diagnosis of OA and should be incorporated into the ACR diagnostic criteria including x-ray, clinical, and lab parameters.

3. MRI may be used for inclusion in clinical studies, but should not be a primary diagnostic tool in a clinical setting.

4. Certain MRI changes that occur in isolation are not diagnostic of OA, including cartilage loss; change in cartilage composition; cystic change and development of bone marrow lesions; and ligamentous, tendinous, and meniscal damage.

5. No single finding is diagnostic of knee OA.

6. MRI findings indicative of knee OA may include abnormalities in all tissues of the joint (bone, cartilage, meniscus, synovium, ligament, and capsule).

7. Given the multiple tissue abnormalities detected by MRI in OA, diagnostic criteria are likely to involve combinations of features.

8. Definite osteophyte production is indicative of OA.

9. Joint space narrowing as assessed by MRI cannot be used as a diagnostic criterion.