Osteoarthritis

CALGARY, ALTA. — Two case studies illustrate the benefits of the osteoporosis risk assessment tool known as FRAX.

The brain child of the World Health Organization's Dr. John A. Kanis, FRAX is a computerized assessment tool that combines bone mineral density at the femoral neck with clinical risk factors to help clinicians determine a patient's 10-year risk of osteoporotic fractures.

The National Osteoporosis Foundation's Clinician's Guide to Prevention and Treatment of Osteoporosis (www.nof.org/professionals/Clinicians_Guide.htm

For example, the guidelines recommend that postmenopausal women, and men aged 50 and older, should be treated when they present with:

P A hip or vertebral (clinical or morphometric) fracture.

P Other prior fractures and low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine).

P T score of −2.5 or less at the femoral neck, total hip, or spine after appropriate evaluation to exclude secondary causes.

P Low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine) and secondary causes associated with high risk of fracture (such as glucocorticoid use or total immobilization).

P A 10-year probability of hip fracture of 3% or greater or a 10-year probability of any major osteoporosis-related fracture of 20% or greater based on the FRAX tool.

Dr. David L. Kendler, who also directs the Osteoporosis Center of British Columbia and is a past president of the International Society for Clinical Densitometry, offered two case examples based on these recommendations. The first is a 54-year-old female smoker with a T score of −2.0. “Her 10-year overall fracture risk would be about 10% and her 10-year hip fracture risk would be about 2.5%, so you would not treat this patient,” he said.

The other example is 81-year-old female with a T score of −1.4. “Her 10-year overall fracture risk is 25% and her 10-year hip fracture risk would be about 3.2%, so you would treat this patient,” said Dr. Kendler, speaking at the annual clinical meeting of the Society of Obstetricians and Gynaecologists of Canada.

FRAX was developed using population-based cohort studies from Europe, North America, Asia, and Australia that represent 249,898 person-years of data. The user is asked to complete fields for age, gender, weight, height, and femoral neck bone mineral density, and to answer yes or no to the following risk factors: previous fracture, parental history of fracture, current tobacco smoker, history of long-term use of glucocorticoids, rheumatoid arthritis, and alcohol intake of three or more units per day.

The user then presses the “calculate” button and the software program provides a 10-year probability of hip fracture and a 10-year probability of a major osteoporotic fracture, defined as one that involves the clinical spine, forearm, hip, or shoulder.

Dr. Kendler, an endocrinologist who is associate professor of medicine at the University of British Columbia, Vancouver, said that the combination of bone mineral density and clinical risk factors “allows us to identify patients at higher risk of osteoporotic fracture. We have moved toward using an intervention threshold based on fracture probability. Treatment will be targeted to patients who will receive the greatest therapeutic benefit.”

According to the International Society for Clinical Densitometry, indications for bone mineral density testing include women age 65 and older; postmenopausal women under age 65 with risk factors; men aged 70 and older; adults with a frailty fracture; adults with a disease or condition associated with low bone mass or bone loss; adults taking medications associated with low bone mass or bone loss; anyone being considered for pharmacologic therapy; anyone being treated for low bone bass, to monitor treatment effect; and anyone not receiving therapy in whom evidence of bone loss would lead to treatment.

Dr. Kendler disclosed receiving grants and/or honoraria from Merck & Co., Eli Lilly & Co., Novartis, Wyeth, Pfizer Inc., Takeda Pharmaceutical Co., and GlaxoSmithKline. The presentation was sponsored by Eli Lilly Canada Inc.

FRAX was developed using population-based cohort studies representing 249,898 person-years of data. DR. KENDLER

CALGARY, ALTA. — Two case studies illustrate the benefits of the osteoporosis risk assessment tool known as FRAX.

The brain child of the World Health Organization's Dr. John A. Kanis, FRAX is a computerized assessment tool that combines bone mineral density at the femoral neck with clinical risk factors to help clinicians determine a patient's 10-year risk of osteoporotic fractures.

The National Osteoporosis Foundation's Clinician's Guide to Prevention and Treatment of Osteoporosis (www.nof.org/professionals/Clinicians_Guide.htm

For example, the guidelines recommend that postmenopausal women, and men aged 50 and older, should be treated when they present with:

P A hip or vertebral (clinical or morphometric) fracture.

P Other prior fractures and low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine).

P T score of −2.5 or less at the femoral neck, total hip, or spine after appropriate evaluation to exclude secondary causes.

P Low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine) and secondary causes associated with high risk of fracture (such as glucocorticoid use or total immobilization).

P A 10-year probability of hip fracture of 3% or greater or a 10-year probability of any major osteoporosis-related fracture of 20% or greater based on the FRAX tool.

Dr. David L. Kendler, who also directs the Osteoporosis Center of British Columbia and is a past president of the International Society for Clinical Densitometry, offered two case examples based on these recommendations. The first is a 54-year-old female smoker with a T score of −2.0. “Her 10-year overall fracture risk would be about 10% and her 10-year hip fracture risk would be about 2.5%, so you would not treat this patient,” he said.

The other example is 81-year-old female with a T score of −1.4. “Her 10-year overall fracture risk is 25% and her 10-year hip fracture risk would be about 3.2%, so you would treat this patient,” said Dr. Kendler, speaking at the annual clinical meeting of the Society of Obstetricians and Gynaecologists of Canada.

FRAX was developed using population-based cohort studies from Europe, North America, Asia, and Australia that represent 249,898 person-years of data. The user is asked to complete fields for age, gender, weight, height, and femoral neck bone mineral density, and to answer yes or no to the following risk factors: previous fracture, parental history of fracture, current tobacco smoker, history of long-term use of glucocorticoids, rheumatoid arthritis, and alcohol intake of three or more units per day.

The user then presses the “calculate” button and the software program provides a 10-year probability of hip fracture and a 10-year probability of a major osteoporotic fracture, defined as one that involves the clinical spine, forearm, hip, or shoulder.

Dr. Kendler, an endocrinologist who is associate professor of medicine at the University of British Columbia, Vancouver, said that the combination of bone mineral density and clinical risk factors “allows us to identify patients at higher risk of osteoporotic fracture. We have moved toward using an intervention threshold based on fracture probability. Treatment will be targeted to patients who will receive the greatest therapeutic benefit.”

According to the International Society for Clinical Densitometry, indications for bone mineral density testing include women age 65 and older; postmenopausal women under age 65 with risk factors; men aged 70 and older; adults with a frailty fracture; adults with a disease or condition associated with low bone mass or bone loss; adults taking medications associated with low bone mass or bone loss; anyone being considered for pharmacologic therapy; anyone being treated for low bone bass, to monitor treatment effect; and anyone not receiving therapy in whom evidence of bone loss would lead to treatment.

Dr. Kendler disclosed receiving grants and/or honoraria from Merck & Co., Eli Lilly & Co., Novartis, Wyeth, Pfizer Inc., Takeda Pharmaceutical Co., and GlaxoSmithKline. The presentation was sponsored by Eli Lilly Canada Inc.

FRAX was developed using population-based cohort studies representing 249,898 person-years of data. DR. KENDLER

CALGARY, ALTA. — Two case studies illustrate the benefits of the osteoporosis risk assessment tool known as FRAX.

The brain child of the World Health Organization's Dr. John A. Kanis, FRAX is a computerized assessment tool that combines bone mineral density at the femoral neck with clinical risk factors to help clinicians determine a patient's 10-year risk of osteoporotic fractures.

The National Osteoporosis Foundation's Clinician's Guide to Prevention and Treatment of Osteoporosis (www.nof.org/professionals/Clinicians_Guide.htm

For example, the guidelines recommend that postmenopausal women, and men aged 50 and older, should be treated when they present with:

P A hip or vertebral (clinical or morphometric) fracture.

P Other prior fractures and low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine).

P T score of −2.5 or less at the femoral neck, total hip, or spine after appropriate evaluation to exclude secondary causes.

P Low bone bass (T score between −1.0 and −2.5 at the femoral neck, total hip, or spine) and secondary causes associated with high risk of fracture (such as glucocorticoid use or total immobilization).

P A 10-year probability of hip fracture of 3% or greater or a 10-year probability of any major osteoporosis-related fracture of 20% or greater based on the FRAX tool.

Dr. David L. Kendler, who also directs the Osteoporosis Center of British Columbia and is a past president of the International Society for Clinical Densitometry, offered two case examples based on these recommendations. The first is a 54-year-old female smoker with a T score of −2.0. “Her 10-year overall fracture risk would be about 10% and her 10-year hip fracture risk would be about 2.5%, so you would not treat this patient,” he said.

The other example is 81-year-old female with a T score of −1.4. “Her 10-year overall fracture risk is 25% and her 10-year hip fracture risk would be about 3.2%, so you would treat this patient,” said Dr. Kendler, speaking at the annual clinical meeting of the Society of Obstetricians and Gynaecologists of Canada.

FRAX was developed using population-based cohort studies from Europe, North America, Asia, and Australia that represent 249,898 person-years of data. The user is asked to complete fields for age, gender, weight, height, and femoral neck bone mineral density, and to answer yes or no to the following risk factors: previous fracture, parental history of fracture, current tobacco smoker, history of long-term use of glucocorticoids, rheumatoid arthritis, and alcohol intake of three or more units per day.

The user then presses the “calculate” button and the software program provides a 10-year probability of hip fracture and a 10-year probability of a major osteoporotic fracture, defined as one that involves the clinical spine, forearm, hip, or shoulder.

Dr. Kendler, an endocrinologist who is associate professor of medicine at the University of British Columbia, Vancouver, said that the combination of bone mineral density and clinical risk factors “allows us to identify patients at higher risk of osteoporotic fracture. We have moved toward using an intervention threshold based on fracture probability. Treatment will be targeted to patients who will receive the greatest therapeutic benefit.”

According to the International Society for Clinical Densitometry, indications for bone mineral density testing include women age 65 and older; postmenopausal women under age 65 with risk factors; men aged 70 and older; adults with a frailty fracture; adults with a disease or condition associated with low bone mass or bone loss; adults taking medications associated with low bone mass or bone loss; anyone being considered for pharmacologic therapy; anyone being treated for low bone bass, to monitor treatment effect; and anyone not receiving therapy in whom evidence of bone loss would lead to treatment.

Dr. Kendler disclosed receiving grants and/or honoraria from Merck & Co., Eli Lilly & Co., Novartis, Wyeth, Pfizer Inc., Takeda Pharmaceutical Co., and GlaxoSmithKline. The presentation was sponsored by Eli Lilly Canada Inc.

FRAX was developed using population-based cohort studies representing 249,898 person-years of data. DR. KENDLER

WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.

“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.

In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.

In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.

Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.

Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).

After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.

“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.

In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.

In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.

Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.

Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).

After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.

“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.

In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.

In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.

Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.

Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).

After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.

ELSEVIER GLOBAL MEDICAL NEWS

Physicians should favor prescribing alendronate for secondary prevention of osteoporotic fragility fractures unless patients cannot take the medication, the clinical effectiveness agency for England and Wales has ruled.

The National Institute for Health and Clinical Excellence's final assessment of preventive drugs for postmenopausal women “who have osteoporosis and have sustained a clinically apparent osteoporotic fragility fracture” also allows other bisphosphonates—along with strontium ranelate, raloxifene, and teriparatide—if patients are intolerant to alendronate, have a contraindication, or cannot comply with the instructions for taking alendronate.

In the event that patients cannot take alendronate, NICE's guideline recommends risedronate and etidronate. A patient's intolerance to etidronate and risedronate allows physicians to move on to strontium ranelate and raloxifene, provided the patient has additional risk factors or meets a stricter bone mineral density threshold.

Teriparatide is recommended if patients have a contraindication, intolerance, or unsatisfactory response to the other drugs and have a combination of very low T scores and at least two fragility fractures.

Alendronate, the least expensive medication (at £53.56 for once-weekly tablets for the generic version), was the most cost effective and was no less effective than were alternatives in preventing fragility fractures in the population, according to the NICE panel that assessed the medications.

But the panel was able to develop thresholds for the use of alternative medications, based on age, clinical risk factors, and T scores, that would not increase the National Health Service's costs by more than £30,000 per quality-adjusted life-year gained.

For example, women aged 55-59 years must have a T score of −3 to qualify for the use of risedronate or etidronate if they do not have an independent risk factor, whereas women aged 70 years or older must have a T score of only −2.5. Women aged 50-54 years do not qualify for any of the alternative medications unless they have an independent clinical risk factor.

The guideline assumes patients are receiving adequate calcium and vitamin D. It also states that a dual-energy x-ray absorptiometry scan may not be necessary for patients 75 years and older, or patients with body mass index lower than 22 kg/m

Physicians should favor prescribing alendronate for secondary prevention of osteoporotic fragility fractures unless patients cannot take the medication, the clinical effectiveness agency for England and Wales has ruled.

The National Institute for Health and Clinical Excellence's final assessment of preventive drugs for postmenopausal women “who have osteoporosis and have sustained a clinically apparent osteoporotic fragility fracture” also allows other bisphosphonates—along with strontium ranelate, raloxifene, and teriparatide—if patients are intolerant to alendronate, have a contraindication, or cannot comply with the instructions for taking alendronate.

In the event that patients cannot take alendronate, NICE's guideline recommends risedronate and etidronate. A patient's intolerance to etidronate and risedronate allows physicians to move on to strontium ranelate and raloxifene, provided the patient has additional risk factors or meets a stricter bone mineral density threshold.

Teriparatide is recommended if patients have a contraindication, intolerance, or unsatisfactory response to the other drugs and have a combination of very low T scores and at least two fragility fractures.

Alendronate, the least expensive medication (at £53.56 for once-weekly tablets for the generic version), was the most cost effective and was no less effective than were alternatives in preventing fragility fractures in the population, according to the NICE panel that assessed the medications.

But the panel was able to develop thresholds for the use of alternative medications, based on age, clinical risk factors, and T scores, that would not increase the National Health Service's costs by more than £30,000 per quality-adjusted life-year gained.

For example, women aged 55-59 years must have a T score of −3 to qualify for the use of risedronate or etidronate if they do not have an independent risk factor, whereas women aged 70 years or older must have a T score of only −2.5. Women aged 50-54 years do not qualify for any of the alternative medications unless they have an independent clinical risk factor.

The guideline assumes patients are receiving adequate calcium and vitamin D. It also states that a dual-energy x-ray absorptiometry scan may not be necessary for patients 75 years and older, or patients with body mass index lower than 22 kg/m

Physicians should favor prescribing alendronate for secondary prevention of osteoporotic fragility fractures unless patients cannot take the medication, the clinical effectiveness agency for England and Wales has ruled.

The National Institute for Health and Clinical Excellence's final assessment of preventive drugs for postmenopausal women “who have osteoporosis and have sustained a clinically apparent osteoporotic fragility fracture” also allows other bisphosphonates—along with strontium ranelate, raloxifene, and teriparatide—if patients are intolerant to alendronate, have a contraindication, or cannot comply with the instructions for taking alendronate.

In the event that patients cannot take alendronate, NICE's guideline recommends risedronate and etidronate. A patient's intolerance to etidronate and risedronate allows physicians to move on to strontium ranelate and raloxifene, provided the patient has additional risk factors or meets a stricter bone mineral density threshold.

Teriparatide is recommended if patients have a contraindication, intolerance, or unsatisfactory response to the other drugs and have a combination of very low T scores and at least two fragility fractures.

Alendronate, the least expensive medication (at £53.56 for once-weekly tablets for the generic version), was the most cost effective and was no less effective than were alternatives in preventing fragility fractures in the population, according to the NICE panel that assessed the medications.

But the panel was able to develop thresholds for the use of alternative medications, based on age, clinical risk factors, and T scores, that would not increase the National Health Service's costs by more than £30,000 per quality-adjusted life-year gained.

For example, women aged 55-59 years must have a T score of −3 to qualify for the use of risedronate or etidronate if they do not have an independent risk factor, whereas women aged 70 years or older must have a T score of only −2.5. Women aged 50-54 years do not qualify for any of the alternative medications unless they have an independent clinical risk factor.

The guideline assumes patients are receiving adequate calcium and vitamin D. It also states that a dual-energy x-ray absorptiometry scan may not be necessary for patients 75 years and older, or patients with body mass index lower than 22 kg/m

A significant association between low bone mass and the presence of bone erosions in patients with psoriatic arthritis suggests there is a relationship between the two in these patients.

Though osteoclasts play a role in both, the relationship between erosions and bone mass in PsA is poorly understood.

Dr. Allen Anandarajah, of the allergy, immunology, and rheumatology unit at the University of Rochester, New York, evaluated data on 1,456 patients with the disease from the Consortium of Rheumatology Researchers of North America (CORRONA) database. “We found the people who had erosions were more likely to have low bone mass,” compared with those who don't have erosions, Dr. Anandarajah said at the annual European Congress of Rheumatology.

The study looked at the association between T scores at the lumbar spine and the presence or absence of erosions, adjusting for steroid use, gender, methotrexate use, other disease-modifying antirheumatic drug use, and the use of biologics, as well as for weight, age, body mass index, and disease index.

Of the patients, 567 (40%) had erosions and 889 (60%) had no erosions. The mean age of patients with erosions was 42 years, significantly younger than the patients with none, whose mean age was 45. Significantly more men (51.5%) had erosions than did women (48.5%).

The association between the presence of bone erosions and lower T scores of the lumbar spine was significant, with significantly lower T scores of the lumbar spine among patients with erosions, compared with those who had no erosions. (Focal erosions could be anywhere, he said, noting that the patients in the database usually had x-rays of the hands and feet. But the database includes information on any x-ray that revealed an erosion.)

“These patients do have low bone mass and … the mechanism between erosions and generalized bone loss or osteoporosis could be a common factor,” Dr. Anandarajah said.

A significant association between low bone mass and the presence of bone erosions in patients with psoriatic arthritis suggests there is a relationship between the two in these patients.

Though osteoclasts play a role in both, the relationship between erosions and bone mass in PsA is poorly understood.

Dr. Allen Anandarajah, of the allergy, immunology, and rheumatology unit at the University of Rochester, New York, evaluated data on 1,456 patients with the disease from the Consortium of Rheumatology Researchers of North America (CORRONA) database. “We found the people who had erosions were more likely to have low bone mass,” compared with those who don't have erosions, Dr. Anandarajah said at the annual European Congress of Rheumatology.

The study looked at the association between T scores at the lumbar spine and the presence or absence of erosions, adjusting for steroid use, gender, methotrexate use, other disease-modifying antirheumatic drug use, and the use of biologics, as well as for weight, age, body mass index, and disease index.

Of the patients, 567 (40%) had erosions and 889 (60%) had no erosions. The mean age of patients with erosions was 42 years, significantly younger than the patients with none, whose mean age was 45. Significantly more men (51.5%) had erosions than did women (48.5%).

The association between the presence of bone erosions and lower T scores of the lumbar spine was significant, with significantly lower T scores of the lumbar spine among patients with erosions, compared with those who had no erosions. (Focal erosions could be anywhere, he said, noting that the patients in the database usually had x-rays of the hands and feet. But the database includes information on any x-ray that revealed an erosion.)

“These patients do have low bone mass and … the mechanism between erosions and generalized bone loss or osteoporosis could be a common factor,” Dr. Anandarajah said.

A significant association between low bone mass and the presence of bone erosions in patients with psoriatic arthritis suggests there is a relationship between the two in these patients.

Though osteoclasts play a role in both, the relationship between erosions and bone mass in PsA is poorly understood.

Dr. Allen Anandarajah, of the allergy, immunology, and rheumatology unit at the University of Rochester, New York, evaluated data on 1,456 patients with the disease from the Consortium of Rheumatology Researchers of North America (CORRONA) database. “We found the people who had erosions were more likely to have low bone mass,” compared with those who don't have erosions, Dr. Anandarajah said at the annual European Congress of Rheumatology.

The study looked at the association between T scores at the lumbar spine and the presence or absence of erosions, adjusting for steroid use, gender, methotrexate use, other disease-modifying antirheumatic drug use, and the use of biologics, as well as for weight, age, body mass index, and disease index.

Of the patients, 567 (40%) had erosions and 889 (60%) had no erosions. The mean age of patients with erosions was 42 years, significantly younger than the patients with none, whose mean age was 45. Significantly more men (51.5%) had erosions than did women (48.5%).

The association between the presence of bone erosions and lower T scores of the lumbar spine was significant, with significantly lower T scores of the lumbar spine among patients with erosions, compared with those who had no erosions. (Focal erosions could be anywhere, he said, noting that the patients in the database usually had x-rays of the hands and feet. But the database includes information on any x-ray that revealed an erosion.)

“These patients do have low bone mass and … the mechanism between erosions and generalized bone loss or osteoporosis could be a common factor,” Dr. Anandarajah said.

SAN FRANCISCO — The prevalence of osteonecrosis of the jaw appears to be about 1 in 1,700 for adults taking long-term oral bisphosphonate therapy, according to an initial analysis of a group of Kaiser Permanente Northern California members.

Dr. Joan Lo surveyed 13,946 members who'd been taking oral bisphosphonates for at least 1 year and had no known exposure to intravenous bisphosphonate. The researchers received 8,568 responses to the mailed survey, which included questions about dental symptoms, said Dr. Lo, an endocrinologist at the Kaiser Permanente Division of Research, at the annual meeting of the Endocrine Society. Respondents who reported a diagnosis of osteonecrosis, or who reported exposed bone, periodontal disease, delayed bone healing, complications after invasive dental procedures, or persistent symptoms of concern were offered a dental exam by dentists on the PROBE study team. Cases of suspected osteonecrosis of the jaw (ONJ)—defined as exposed bone for greater than 8 weeks in the maxillofacial region, absent prior radiation—were referred for further examination by an oral surgeon. Dental records were reviewed in cases where patients declined a dental exam. Pharmacy records were also reviewed for all patients.

Of those who responded, about 6,402 patients did not have any symptoms of concern. A little more than 2,000 had symptoms of concern; 1,000 of those patients were examined by a dentist.

Dr. Lo said the team had identified eight cases of ONJ so far, for a prevalence of 0.09%, or 1 in 1,100. Three were localized to the palatal torus, and one in the mandible. The remaining four had bone exposure in the mandible following extraction. The confirmed cases had variable areas of bone exposure, variable locations, and various predisposing factors, she said.

In addition, the researchers identified an additional nine patients who had ONJ-like features but did not meet the classic definition of bisphosphonate-related ONJ. Three patients had signs of osteomyelitis of the mandible; an additional four had transient exposure, and another had a small area of bone exposure that persisted up to 1 year but eventually healed after a tooth extraction. The ninth patient had spontaneous tooth loss. Five had evidence of radiographic abnormalities, said Dr. Lo.

With these additional ONJ-like cases, the prevalence increased to 0.2%. Extrapolated to the entire cohort of patients taking bisphosphonates, the prevalence was 1 in 1,729, said Dr. Lo.

The current definition of bisphosphonate-related ONJ may not cover the spectrum of jaw complications seen in patients with long-term exposure, and may underestimate ONJ's prevalence, said Dr. Lo.

Such complications include nonhealing extraction sites and osteomyelitis or osteoporosis without exposed bone. The Kaiser researchers will continue to compile dental records to come up with a more accurate estimate of prevalence, she said.

Dr. Lo disclosed no conflicts of interest related to the study.

SAN FRANCISCO — The prevalence of osteonecrosis of the jaw appears to be about 1 in 1,700 for adults taking long-term oral bisphosphonate therapy, according to an initial analysis of a group of Kaiser Permanente Northern California members.

Dr. Joan Lo surveyed 13,946 members who'd been taking oral bisphosphonates for at least 1 year and had no known exposure to intravenous bisphosphonate. The researchers received 8,568 responses to the mailed survey, which included questions about dental symptoms, said Dr. Lo, an endocrinologist at the Kaiser Permanente Division of Research, at the annual meeting of the Endocrine Society. Respondents who reported a diagnosis of osteonecrosis, or who reported exposed bone, periodontal disease, delayed bone healing, complications after invasive dental procedures, or persistent symptoms of concern were offered a dental exam by dentists on the PROBE study team. Cases of suspected osteonecrosis of the jaw (ONJ)—defined as exposed bone for greater than 8 weeks in the maxillofacial region, absent prior radiation—were referred for further examination by an oral surgeon. Dental records were reviewed in cases where patients declined a dental exam. Pharmacy records were also reviewed for all patients.

Of those who responded, about 6,402 patients did not have any symptoms of concern. A little more than 2,000 had symptoms of concern; 1,000 of those patients were examined by a dentist.

Dr. Lo said the team had identified eight cases of ONJ so far, for a prevalence of 0.09%, or 1 in 1,100. Three were localized to the palatal torus, and one in the mandible. The remaining four had bone exposure in the mandible following extraction. The confirmed cases had variable areas of bone exposure, variable locations, and various predisposing factors, she said.

In addition, the researchers identified an additional nine patients who had ONJ-like features but did not meet the classic definition of bisphosphonate-related ONJ. Three patients had signs of osteomyelitis of the mandible; an additional four had transient exposure, and another had a small area of bone exposure that persisted up to 1 year but eventually healed after a tooth extraction. The ninth patient had spontaneous tooth loss. Five had evidence of radiographic abnormalities, said Dr. Lo.

With these additional ONJ-like cases, the prevalence increased to 0.2%. Extrapolated to the entire cohort of patients taking bisphosphonates, the prevalence was 1 in 1,729, said Dr. Lo.

The current definition of bisphosphonate-related ONJ may not cover the spectrum of jaw complications seen in patients with long-term exposure, and may underestimate ONJ's prevalence, said Dr. Lo.

Such complications include nonhealing extraction sites and osteomyelitis or osteoporosis without exposed bone. The Kaiser researchers will continue to compile dental records to come up with a more accurate estimate of prevalence, she said.

Dr. Lo disclosed no conflicts of interest related to the study.

SAN FRANCISCO — The prevalence of osteonecrosis of the jaw appears to be about 1 in 1,700 for adults taking long-term oral bisphosphonate therapy, according to an initial analysis of a group of Kaiser Permanente Northern California members.

Dr. Joan Lo surveyed 13,946 members who'd been taking oral bisphosphonates for at least 1 year and had no known exposure to intravenous bisphosphonate. The researchers received 8,568 responses to the mailed survey, which included questions about dental symptoms, said Dr. Lo, an endocrinologist at the Kaiser Permanente Division of Research, at the annual meeting of the Endocrine Society. Respondents who reported a diagnosis of osteonecrosis, or who reported exposed bone, periodontal disease, delayed bone healing, complications after invasive dental procedures, or persistent symptoms of concern were offered a dental exam by dentists on the PROBE study team. Cases of suspected osteonecrosis of the jaw (ONJ)—defined as exposed bone for greater than 8 weeks in the maxillofacial region, absent prior radiation—were referred for further examination by an oral surgeon. Dental records were reviewed in cases where patients declined a dental exam. Pharmacy records were also reviewed for all patients.

Of those who responded, about 6,402 patients did not have any symptoms of concern. A little more than 2,000 had symptoms of concern; 1,000 of those patients were examined by a dentist.

Dr. Lo said the team had identified eight cases of ONJ so far, for a prevalence of 0.09%, or 1 in 1,100. Three were localized to the palatal torus, and one in the mandible. The remaining four had bone exposure in the mandible following extraction. The confirmed cases had variable areas of bone exposure, variable locations, and various predisposing factors, she said.

In addition, the researchers identified an additional nine patients who had ONJ-like features but did not meet the classic definition of bisphosphonate-related ONJ. Three patients had signs of osteomyelitis of the mandible; an additional four had transient exposure, and another had a small area of bone exposure that persisted up to 1 year but eventually healed after a tooth extraction. The ninth patient had spontaneous tooth loss. Five had evidence of radiographic abnormalities, said Dr. Lo.

With these additional ONJ-like cases, the prevalence increased to 0.2%. Extrapolated to the entire cohort of patients taking bisphosphonates, the prevalence was 1 in 1,729, said Dr. Lo.

The current definition of bisphosphonate-related ONJ may not cover the spectrum of jaw complications seen in patients with long-term exposure, and may underestimate ONJ's prevalence, said Dr. Lo.

Such complications include nonhealing extraction sites and osteomyelitis or osteoporosis without exposed bone. The Kaiser researchers will continue to compile dental records to come up with a more accurate estimate of prevalence, she said.

Dr. Lo disclosed no conflicts of interest related to the study.

Clinicians should assess older men for risk factors for osteoporosis and measure bone density by dual-energy x-ray absorptiometry if any risk factors are present, a new guideline from the American College of Physicians recommends.

How old is “older” is left open to interpretation and is one point of difference between the ACP guideline and guidelines issued by the National Osteoporosis Foundation (NOF) in February 2008.

The new NOF guidelines include screening and treatment in men as well as women, and recommend bone density testing in men aged 50–69 who have risk factors for osteoporosis and in all men aged 70 or older (RHEUMATOLOGY NEWS, May 2008, p. 1).

The ACP guidelines (Ann. Intern. Med. 2008;148:680-4) focus specifically on screening in men and notes the appropriate age at which to start risk assessment is uncertain. The medical evidence in the literature shows that by 65, at least 6% of men have osteoporosis proved by dual-energy x-ray absorptiometry (DXA), Dr. Amir Qaseem said in an interview.

The ACP plans to issue a separate new guideline for treating osteoporosis in men in the near future, added Dr. Qaseem, lead author of the guideline and a senior medical associate for the ACP.

The main risk factors for osteoporosis in men are age older than 70, a body mass index of 25 kg/m

The new ACP guideline is based on a systematic review of evidence published in 1990–2007 conducted by the federal Agency for Healthcare Research and Quality's evidence-based practice center in Southern California.

The prevalence of osteoporosis is estimated to be 7% in white, 5% in black, and 3% in Hispanic men, Dr. Qaseem noted. Over the next 15 years the rate of osteoporosis in U.S. men is expected to increase by half, with a doubling or tripling of hip fracture rates by 2040.

The prevalence of osteoporosis in Asian American men and other ethnic groups is unknown because of a lack of data. More research is needed, the guideline states.

Clinicians should assess older men for risk factors for osteoporosis and measure bone density by dual-energy x-ray absorptiometry if any risk factors are present, a new guideline from the American College of Physicians recommends.

How old is “older” is left open to interpretation and is one point of difference between the ACP guideline and guidelines issued by the National Osteoporosis Foundation (NOF) in February 2008.

The new NOF guidelines include screening and treatment in men as well as women, and recommend bone density testing in men aged 50–69 who have risk factors for osteoporosis and in all men aged 70 or older (RHEUMATOLOGY NEWS, May 2008, p. 1).

The ACP guidelines (Ann. Intern. Med. 2008;148:680-4) focus specifically on screening in men and notes the appropriate age at which to start risk assessment is uncertain. The medical evidence in the literature shows that by 65, at least 6% of men have osteoporosis proved by dual-energy x-ray absorptiometry (DXA), Dr. Amir Qaseem said in an interview.

The ACP plans to issue a separate new guideline for treating osteoporosis in men in the near future, added Dr. Qaseem, lead author of the guideline and a senior medical associate for the ACP.

The main risk factors for osteoporosis in men are age older than 70, a body mass index of 25 kg/m

The new ACP guideline is based on a systematic review of evidence published in 1990–2007 conducted by the federal Agency for Healthcare Research and Quality's evidence-based practice center in Southern California.

The prevalence of osteoporosis is estimated to be 7% in white, 5% in black, and 3% in Hispanic men, Dr. Qaseem noted. Over the next 15 years the rate of osteoporosis in U.S. men is expected to increase by half, with a doubling or tripling of hip fracture rates by 2040.

The prevalence of osteoporosis in Asian American men and other ethnic groups is unknown because of a lack of data. More research is needed, the guideline states.

Clinicians should assess older men for risk factors for osteoporosis and measure bone density by dual-energy x-ray absorptiometry if any risk factors are present, a new guideline from the American College of Physicians recommends.

How old is “older” is left open to interpretation and is one point of difference between the ACP guideline and guidelines issued by the National Osteoporosis Foundation (NOF) in February 2008.

The new NOF guidelines include screening and treatment in men as well as women, and recommend bone density testing in men aged 50–69 who have risk factors for osteoporosis and in all men aged 70 or older (RHEUMATOLOGY NEWS, May 2008, p. 1).

The ACP guidelines (Ann. Intern. Med. 2008;148:680-4) focus specifically on screening in men and notes the appropriate age at which to start risk assessment is uncertain. The medical evidence in the literature shows that by 65, at least 6% of men have osteoporosis proved by dual-energy x-ray absorptiometry (DXA), Dr. Amir Qaseem said in an interview.

The ACP plans to issue a separate new guideline for treating osteoporosis in men in the near future, added Dr. Qaseem, lead author of the guideline and a senior medical associate for the ACP.

The main risk factors for osteoporosis in men are age older than 70, a body mass index of 25 kg/m

The new ACP guideline is based on a systematic review of evidence published in 1990–2007 conducted by the federal Agency for Healthcare Research and Quality's evidence-based practice center in Southern California.

The prevalence of osteoporosis is estimated to be 7% in white, 5% in black, and 3% in Hispanic men, Dr. Qaseem noted. Over the next 15 years the rate of osteoporosis in U.S. men is expected to increase by half, with a doubling or tripling of hip fracture rates by 2040.

The prevalence of osteoporosis in Asian American men and other ethnic groups is unknown because of a lack of data. More research is needed, the guideline states.

LIVERPOOL, ENGLAND — Maternal exposure to sunlight in late pregnancy can have a beneficial influence on the offspring's bone mineral density in later life, Dr. Nicola J. Goodson said at the annual meeting of the British Society for Rheumatology.

“In the United Kingdom, the main dietary sources of vitamin D are fish and fortified margarine, but more than 90% of the vitamin is obtained by casual exposure to the sun, and because of the latitude the majority of the population is vitamin D deficient for much of the year,” said Dr. Goodson of University Hospital Aintree, University of Liverpool (England).

Birth records and dual-energy x-ray absorptiometry (DXA) scan results were examined for 15,042 women and 2,160 men from the Morecambe Bay catchment district. The mean age was 62 years.

At the latitude of this district, 54 degrees north, the months with adequate sunlight are May through September. Patients therefore were categorized as having infant sunlight exposure if their birth months were between March and September and they could be expected to have at least 1 month of exposure to ultraviolet B light in the first 3 months of life. They were classified as antenatal exposure if their birth months were between May and November and they had at least 1 neonatal month of exposure to sunlight, said Dr. Goodson.

Overall, 51% of patients had BMD in the normal range. As expected, women had lower mean T scores, at −1.7, than did men, at −0.91, she said.

Analysis of sunlight exposure in the first 3 months of life and normal BMD, after adjustment for age at the time of the DXA scan, found no significant association, with an odds ratio (OR) of 1.

In contrast, for those categorized as antenatal exposure, there was a modest association with normal bone mineral density in adulthood, with an OR of 1.16, Dr. Goodson said. Those patients who had antenatal sunlight exposure also were likely to have osteopenia or osteoporosis: Those who were osteopenic had a 12% reduced odds of antenatal exposure and those who were osteoporotic had a 19% reduced odds of antenatal exposure, she said.

These associations were only seen among women.

In a separate analysis for those whose DXA scans were done before age 50, there was no association of early life sunlight exposure in either men or women. However, in these younger patients there was a very strong association of early life, rather than antenatal, exposure with osteoporosis. “Those patients in the osteoporotic range had a 49% reduced odds of having a birth month that enabled antenatal exposure to UVB,” she said.

In summary, she said, adult BMD was associated with birth month in this unselected DXA cohort.

“Maternal vitamin D levels should be optimized, particularly during the third trimester, either by diet or by safe UV exposure,” Dr. Goodson said.

LIVERPOOL, ENGLAND — Maternal exposure to sunlight in late pregnancy can have a beneficial influence on the offspring's bone mineral density in later life, Dr. Nicola J. Goodson said at the annual meeting of the British Society for Rheumatology.

“In the United Kingdom, the main dietary sources of vitamin D are fish and fortified margarine, but more than 90% of the vitamin is obtained by casual exposure to the sun, and because of the latitude the majority of the population is vitamin D deficient for much of the year,” said Dr. Goodson of University Hospital Aintree, University of Liverpool (England).

Birth records and dual-energy x-ray absorptiometry (DXA) scan results were examined for 15,042 women and 2,160 men from the Morecambe Bay catchment district. The mean age was 62 years.

At the latitude of this district, 54 degrees north, the months with adequate sunlight are May through September. Patients therefore were categorized as having infant sunlight exposure if their birth months were between March and September and they could be expected to have at least 1 month of exposure to ultraviolet B light in the first 3 months of life. They were classified as antenatal exposure if their birth months were between May and November and they had at least 1 neonatal month of exposure to sunlight, said Dr. Goodson.

Overall, 51% of patients had BMD in the normal range. As expected, women had lower mean T scores, at −1.7, than did men, at −0.91, she said.

Analysis of sunlight exposure in the first 3 months of life and normal BMD, after adjustment for age at the time of the DXA scan, found no significant association, with an odds ratio (OR) of 1.

In contrast, for those categorized as antenatal exposure, there was a modest association with normal bone mineral density in adulthood, with an OR of 1.16, Dr. Goodson said. Those patients who had antenatal sunlight exposure also were likely to have osteopenia or osteoporosis: Those who were osteopenic had a 12% reduced odds of antenatal exposure and those who were osteoporotic had a 19% reduced odds of antenatal exposure, she said.

These associations were only seen among women.

In a separate analysis for those whose DXA scans were done before age 50, there was no association of early life sunlight exposure in either men or women. However, in these younger patients there was a very strong association of early life, rather than antenatal, exposure with osteoporosis. “Those patients in the osteoporotic range had a 49% reduced odds of having a birth month that enabled antenatal exposure to UVB,” she said.

In summary, she said, adult BMD was associated with birth month in this unselected DXA cohort.

“Maternal vitamin D levels should be optimized, particularly during the third trimester, either by diet or by safe UV exposure,” Dr. Goodson said.

LIVERPOOL, ENGLAND — Maternal exposure to sunlight in late pregnancy can have a beneficial influence on the offspring's bone mineral density in later life, Dr. Nicola J. Goodson said at the annual meeting of the British Society for Rheumatology.

“In the United Kingdom, the main dietary sources of vitamin D are fish and fortified margarine, but more than 90% of the vitamin is obtained by casual exposure to the sun, and because of the latitude the majority of the population is vitamin D deficient for much of the year,” said Dr. Goodson of University Hospital Aintree, University of Liverpool (England).

Birth records and dual-energy x-ray absorptiometry (DXA) scan results were examined for 15,042 women and 2,160 men from the Morecambe Bay catchment district. The mean age was 62 years.

At the latitude of this district, 54 degrees north, the months with adequate sunlight are May through September. Patients therefore were categorized as having infant sunlight exposure if their birth months were between March and September and they could be expected to have at least 1 month of exposure to ultraviolet B light in the first 3 months of life. They were classified as antenatal exposure if their birth months were between May and November and they had at least 1 neonatal month of exposure to sunlight, said Dr. Goodson.

Overall, 51% of patients had BMD in the normal range. As expected, women had lower mean T scores, at −1.7, than did men, at −0.91, she said.

Analysis of sunlight exposure in the first 3 months of life and normal BMD, after adjustment for age at the time of the DXA scan, found no significant association, with an odds ratio (OR) of 1.

In contrast, for those categorized as antenatal exposure, there was a modest association with normal bone mineral density in adulthood, with an OR of 1.16, Dr. Goodson said. Those patients who had antenatal sunlight exposure also were likely to have osteopenia or osteoporosis: Those who were osteopenic had a 12% reduced odds of antenatal exposure and those who were osteoporotic had a 19% reduced odds of antenatal exposure, she said.

These associations were only seen among women.

In a separate analysis for those whose DXA scans were done before age 50, there was no association of early life sunlight exposure in either men or women. However, in these younger patients there was a very strong association of early life, rather than antenatal, exposure with osteoporosis. “Those patients in the osteoporotic range had a 49% reduced odds of having a birth month that enabled antenatal exposure to UVB,” she said.

In summary, she said, adult BMD was associated with birth month in this unselected DXA cohort.

“Maternal vitamin D levels should be optimized, particularly during the third trimester, either by diet or by safe UV exposure,” Dr. Goodson said.

HONOLULU — Bazedoxifene is effective in preventing osteoporosis in postmenopausal women, according to the results of a 2-year, phase III, placebo-controlled trial presented at the annual meeting of the American Society for Bone and Mineral Research.

“In relatively young, healthy, postmenopausal women with normal or low bone mineral density, bazedoxifene treatment prevented bone loss, reduced bone turnover, was generally well tolerated, had a neutral effect on endometrial tissue, and, for the primary end point, had similar BMD efficacy as raloxifene,” said Dr. Paul D. Miller, of the University of Colorado Medical Center, Denver. In addition, “bazedoxifene had a favorable risk-benefit profile, supporting its use for the prevention of postmenopausal early bone loss.”

A novel selective estrogen receptor modulator, bazedoxifene has been under development as monotherapy for the prevention and treatment of postmenopausal osteoporosis. In late April 2007, the Food and Drug Administration issued an approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis; this study was designed to assess the efficacy and safety of the drug for this purpose.

Study participants were healthy postmenopausal women aged 45 years, whose femoral neck bone or lumbar spine T scores were not less than -2.5. Women with vasomotor symptoms that required treatment, as well as those with bone diseases, previous vertebral fractures, or endometrial hyperplasia, were excluded.

In the trial, a total of 1,583 postmenopausal women were randomized to daily bazedoxifene regimens of 10 mg, 20 mg, or 40 mg, or to raloxifene (60 mg), or to placebo. In addition, all women received a daily calcium supplement of 600 mg.

Of 1,583 women enrolled, 1,113 (70%) completed the 2-year study. More than 90% of women in each treatment group were white. Mean body mass index (kg/m

The primary outcome was the percent change in the BMD of the lumbar spine after 24 months of treatment. BMD at other skeletal sites was a secondary outcome.

By month 24 of treatment, BMD loss was prevented in all treatment groups with the exception of women using placebo, who experienced a significant decline in BMD. More specifically, the percent change in lumbar spine BMD from baseline—relative to placebo—was 1.1%, 1.4%, and 1.5%, for bazedoxifene 10 mg, 20 mg, and 40 mg, respectively; it was 1.5% for raloxifene 60 mg (P less than .001). Similar dose-response results were found at other skeletal sites for women using bazedoxifene.

Adverse event rates were similar among treatment groups, as were serious adverse event rates and adverse event-caused discontinuations.

Vasodilation was found more often in patients using bazedoxifene 20 mg (20%) and 40 mg (23%) and raloxifene 60 mg (18%), compared with those using placebo (13%). Other cardiovascular adverse event rates were similarly low in all treatment groups. All treatment groups had a similar incidence of leg cramps, ranging from 9% to nearly 12%. All treatment groups had a low incidence of venous thrombotic adverse events, including fewer than 1% of patients using bazedoxifene at any dosage.

The study was supported by Wyeth Research and Wyeth Pharmaceuticals. Dr. Miller also disclosed various financial relationships to a number of research companies, including Wyeth.

HONOLULU — Bazedoxifene is effective in preventing osteoporosis in postmenopausal women, according to the results of a 2-year, phase III, placebo-controlled trial presented at the annual meeting of the American Society for Bone and Mineral Research.

“In relatively young, healthy, postmenopausal women with normal or low bone mineral density, bazedoxifene treatment prevented bone loss, reduced bone turnover, was generally well tolerated, had a neutral effect on endometrial tissue, and, for the primary end point, had similar BMD efficacy as raloxifene,” said Dr. Paul D. Miller, of the University of Colorado Medical Center, Denver. In addition, “bazedoxifene had a favorable risk-benefit profile, supporting its use for the prevention of postmenopausal early bone loss.”

A novel selective estrogen receptor modulator, bazedoxifene has been under development as monotherapy for the prevention and treatment of postmenopausal osteoporosis. In late April 2007, the Food and Drug Administration issued an approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis; this study was designed to assess the efficacy and safety of the drug for this purpose.

Study participants were healthy postmenopausal women aged 45 years, whose femoral neck bone or lumbar spine T scores were not less than -2.5. Women with vasomotor symptoms that required treatment, as well as those with bone diseases, previous vertebral fractures, or endometrial hyperplasia, were excluded.

In the trial, a total of 1,583 postmenopausal women were randomized to daily bazedoxifene regimens of 10 mg, 20 mg, or 40 mg, or to raloxifene (60 mg), or to placebo. In addition, all women received a daily calcium supplement of 600 mg.

Of 1,583 women enrolled, 1,113 (70%) completed the 2-year study. More than 90% of women in each treatment group were white. Mean body mass index (kg/m

The primary outcome was the percent change in the BMD of the lumbar spine after 24 months of treatment. BMD at other skeletal sites was a secondary outcome.

By month 24 of treatment, BMD loss was prevented in all treatment groups with the exception of women using placebo, who experienced a significant decline in BMD. More specifically, the percent change in lumbar spine BMD from baseline—relative to placebo—was 1.1%, 1.4%, and 1.5%, for bazedoxifene 10 mg, 20 mg, and 40 mg, respectively; it was 1.5% for raloxifene 60 mg (P less than .001). Similar dose-response results were found at other skeletal sites for women using bazedoxifene.

Adverse event rates were similar among treatment groups, as were serious adverse event rates and adverse event-caused discontinuations.

Vasodilation was found more often in patients using bazedoxifene 20 mg (20%) and 40 mg (23%) and raloxifene 60 mg (18%), compared with those using placebo (13%). Other cardiovascular adverse event rates were similarly low in all treatment groups. All treatment groups had a similar incidence of leg cramps, ranging from 9% to nearly 12%. All treatment groups had a low incidence of venous thrombotic adverse events, including fewer than 1% of patients using bazedoxifene at any dosage.

The study was supported by Wyeth Research and Wyeth Pharmaceuticals. Dr. Miller also disclosed various financial relationships to a number of research companies, including Wyeth.

HONOLULU — Bazedoxifene is effective in preventing osteoporosis in postmenopausal women, according to the results of a 2-year, phase III, placebo-controlled trial presented at the annual meeting of the American Society for Bone and Mineral Research.

“In relatively young, healthy, postmenopausal women with normal or low bone mineral density, bazedoxifene treatment prevented bone loss, reduced bone turnover, was generally well tolerated, had a neutral effect on endometrial tissue, and, for the primary end point, had similar BMD efficacy as raloxifene,” said Dr. Paul D. Miller, of the University of Colorado Medical Center, Denver. In addition, “bazedoxifene had a favorable risk-benefit profile, supporting its use for the prevention of postmenopausal early bone loss.”

A novel selective estrogen receptor modulator, bazedoxifene has been under development as monotherapy for the prevention and treatment of postmenopausal osteoporosis. In late April 2007, the Food and Drug Administration issued an approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis; this study was designed to assess the efficacy and safety of the drug for this purpose.

Study participants were healthy postmenopausal women aged 45 years, whose femoral neck bone or lumbar spine T scores were not less than -2.5. Women with vasomotor symptoms that required treatment, as well as those with bone diseases, previous vertebral fractures, or endometrial hyperplasia, were excluded.

In the trial, a total of 1,583 postmenopausal women were randomized to daily bazedoxifene regimens of 10 mg, 20 mg, or 40 mg, or to raloxifene (60 mg), or to placebo. In addition, all women received a daily calcium supplement of 600 mg.

Of 1,583 women enrolled, 1,113 (70%) completed the 2-year study. More than 90% of women in each treatment group were white. Mean body mass index (kg/m

The primary outcome was the percent change in the BMD of the lumbar spine after 24 months of treatment. BMD at other skeletal sites was a secondary outcome.

By month 24 of treatment, BMD loss was prevented in all treatment groups with the exception of women using placebo, who experienced a significant decline in BMD. More specifically, the percent change in lumbar spine BMD from baseline—relative to placebo—was 1.1%, 1.4%, and 1.5%, for bazedoxifene 10 mg, 20 mg, and 40 mg, respectively; it was 1.5% for raloxifene 60 mg (P less than .001). Similar dose-response results were found at other skeletal sites for women using bazedoxifene.

Adverse event rates were similar among treatment groups, as were serious adverse event rates and adverse event-caused discontinuations.

Vasodilation was found more often in patients using bazedoxifene 20 mg (20%) and 40 mg (23%) and raloxifene 60 mg (18%), compared with those using placebo (13%). Other cardiovascular adverse event rates were similarly low in all treatment groups. All treatment groups had a similar incidence of leg cramps, ranging from 9% to nearly 12%. All treatment groups had a low incidence of venous thrombotic adverse events, including fewer than 1% of patients using bazedoxifene at any dosage.

The study was supported by Wyeth Research and Wyeth Pharmaceuticals. Dr. Miller also disclosed various financial relationships to a number of research companies, including Wyeth.

NEW YORK — Overtreatment for low bone mass has been all too common in women aged 50–60 years since the introduction of the bisphosphonate drugs and the widespread use of bone scans, according to Dr. Stephen Honig.

Routine bone scanning at menopause—very common in this country—creates difficulties in treatment decisions for clinicians, because when low bone density is uncovered in the early postmenopausal years it generally is in the range of osteopenia, not osteoporosis.

“A common scenario has been a 50-year-old woman who has her last period, goes for a bone scan, and has a spinal T score of −2.2. She's given a prescription for Fosamax, and 10 years later she's still on the drug,” Dr. Honig said at a rheumatology meeting sponsored by New York University.

It's important to recognize that for women in the early years after menopause, a bone mineral density measurement does not provide the clinician with enough information to make appropriate treatment decisions.

What is needed is an understanding of an individual woman's risk of fracture in the short and intermediate term, balanced against the consequences of adverse events and the possibility of subtrochanteric fractures associated with excessive suppression of bone turnover.

“We want to avoid overtreating—too much drug, too soon, for too long—and of course we also want to avoid undertreating,” he said, adding that many women in their 60s and most women in their 70s can benefit from bone-strengthening therapy.

“For women in their 50s, however, what we really need to know is who is at risk for fracture, not just who has osteopenia,” said Dr. Honig of New York University, New York.

Fractures in women of this age are not simply a result of bone loss. Fractures occur when mechanical forces overcome the bone's capacity for resistance. This bone strength is dependent on structural and material properties of the bone, including size, shape, trabecular architecture, and mineral-to-matrix ratio.

Clearly, other factors also contribute. In the National Osteoporosis Risk Assessment (NORA), which included 200,160 women aged 50 years and older, factors significantly associated with fractures included low bone mineral density, poor health status, personal or family history of fracture, maternal history of osteoporosis, no current hormone replacement therapy, menopause before age 40, corticosteroid use, and current smoking.

Analysis of the NORA data also found that the most important determinants of 3-year fracture risk in women aged 50–64 years were prior fracture, T score at or below −1.1, and self-reported fair/poor health status, with fracture risks of 7.2%, 3.1%, and 2.4%, respectively (Osteoporos. Int. 2007;18:1287–96).

A further difference in fracture risk between women in the early postmenopausal years and those who are older is that the fracture of primary concern is not the hip, but the wrist/forearm. In the Danish Osteoporosis Prevention Study, 872 women whose mean age was 51 years were followed for 10 years.

During that time, 80 fractures occurred in 78 women. There were a total of 64 in the forearm, 8 in the spine, 7 in the proximal humerus, and only 1 in the hip (J. Bone Miner. Res. 2006;21:796–800).

Studies have shown that at menopause, the rate of falls among women begins to increase dramatically. In a study from the United Kingdom that analyzed 90,061 accidents, 38,737 were classified as “underfoot” (events such as slipping or tripping). Among women overall, 51% of accidents were underfoot, as were 32% of accidents in men, but after the age of 50 these numbers increased to 64% in women and 43% in men (Q. J. Med. 2001;94:699–707).

It turns out estrogen has a critical role in postural stability, Dr. Honig said. Declining estradiol levels are associated with decreasing ability to maintain balance, slower reaction and movement times, and lower muscle strength—all of which contribute to falling and injury.

“Most clinicians never give a second thought to the issue of balance in a 50-year-old woman,” Dr. Honig said.

Having a fall-related fracture also is a risk factor for an additional fracture. Longer-term follow-up of the NORA cohort found that over 3 years, a prior wrist fracture increased the risk of a future wrist fracture about threefold and doubled the risk of any osteoporotic fracture (Osteoporos. Int. 2008;19:607–13).

In conclusion, healthy young postmenopausal women with low bone mass and no recent fracture history have a low 1- to 3-year risk of fracturing, Dr. Honig said. For these patients, according to new 2008 guidelines from the National Osteoporosis Foundation, treatment should be initiated only if their 10-year hip fracture probability is 3% or greater or their 10-year all-fracture probability is 20% or greater, based on the U.S.-adapted World Health Organization absolute fracture risk model.

The guidelines are available on the Web site of the National Osteoporosis Foundation, at www.nof.orgwww.shef.ac.uk/FRAX

Dr. Honig serves on the speakers bureau of Novartis Pharmaceuticals Corp.

Subtrochanteric fracture is seen in a patient who had been on bisphosphonate therapy. BMD measurement alone may not accurately predict fracture risk.

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK — Overtreatment for low bone mass has been all too common in women aged 50–60 years since the introduction of the bisphosphonate drugs and the widespread use of bone scans, according to Dr. Stephen Honig.

Routine bone scanning at menopause—very common in this country—creates difficulties in treatment decisions for clinicians, because when low bone density is uncovered in the early postmenopausal years it generally is in the range of osteopenia, not osteoporosis.

“A common scenario has been a 50-year-old woman who has her last period, goes for a bone scan, and has a spinal T score of −2.2. She's given a prescription for Fosamax, and 10 years later she's still on the drug,” Dr. Honig said at a rheumatology meeting sponsored by New York University.

It's important to recognize that for women in the early years after menopause, a bone mineral density measurement does not provide the clinician with enough information to make appropriate treatment decisions.

What is needed is an understanding of an individual woman's risk of fracture in the short and intermediate term, balanced against the consequences of adverse events and the possibility of subtrochanteric fractures associated with excessive suppression of bone turnover.

“We want to avoid overtreating—too much drug, too soon, for too long—and of course we also want to avoid undertreating,” he said, adding that many women in their 60s and most women in their 70s can benefit from bone-strengthening therapy.

“For women in their 50s, however, what we really need to know is who is at risk for fracture, not just who has osteopenia,” said Dr. Honig of New York University, New York.

Fractures in women of this age are not simply a result of bone loss. Fractures occur when mechanical forces overcome the bone's capacity for resistance. This bone strength is dependent on structural and material properties of the bone, including size, shape, trabecular architecture, and mineral-to-matrix ratio.

Clearly, other factors also contribute. In the National Osteoporosis Risk Assessment (NORA), which included 200,160 women aged 50 years and older, factors significantly associated with fractures included low bone mineral density, poor health status, personal or family history of fracture, maternal history of osteoporosis, no current hormone replacement therapy, menopause before age 40, corticosteroid use, and current smoking.

Analysis of the NORA data also found that the most important determinants of 3-year fracture risk in women aged 50–64 years were prior fracture, T score at or below −1.1, and self-reported fair/poor health status, with fracture risks of 7.2%, 3.1%, and 2.4%, respectively (Osteoporos. Int. 2007;18:1287–96).

A further difference in fracture risk between women in the early postmenopausal years and those who are older is that the fracture of primary concern is not the hip, but the wrist/forearm. In the Danish Osteoporosis Prevention Study, 872 women whose mean age was 51 years were followed for 10 years.

During that time, 80 fractures occurred in 78 women. There were a total of 64 in the forearm, 8 in the spine, 7 in the proximal humerus, and only 1 in the hip (J. Bone Miner. Res. 2006;21:796–800).

Studies have shown that at menopause, the rate of falls among women begins to increase dramatically. In a study from the United Kingdom that analyzed 90,061 accidents, 38,737 were classified as “underfoot” (events such as slipping or tripping). Among women overall, 51% of accidents were underfoot, as were 32% of accidents in men, but after the age of 50 these numbers increased to 64% in women and 43% in men (Q. J. Med. 2001;94:699–707).

It turns out estrogen has a critical role in postural stability, Dr. Honig said. Declining estradiol levels are associated with decreasing ability to maintain balance, slower reaction and movement times, and lower muscle strength—all of which contribute to falling and injury.

“Most clinicians never give a second thought to the issue of balance in a 50-year-old woman,” Dr. Honig said.

Having a fall-related fracture also is a risk factor for an additional fracture. Longer-term follow-up of the NORA cohort found that over 3 years, a prior wrist fracture increased the risk of a future wrist fracture about threefold and doubled the risk of any osteoporotic fracture (Osteoporos. Int. 2008;19:607–13).

In conclusion, healthy young postmenopausal women with low bone mass and no recent fracture history have a low 1- to 3-year risk of fracturing, Dr. Honig said. For these patients, according to new 2008 guidelines from the National Osteoporosis Foundation, treatment should be initiated only if their 10-year hip fracture probability is 3% or greater or their 10-year all-fracture probability is 20% or greater, based on the U.S.-adapted World Health Organization absolute fracture risk model.

The guidelines are available on the Web site of the National Osteoporosis Foundation, at www.nof.orgwww.shef.ac.uk/FRAX

Dr. Honig serves on the speakers bureau of Novartis Pharmaceuticals Corp.

Subtrochanteric fracture is seen in a patient who had been on bisphosphonate therapy. BMD measurement alone may not accurately predict fracture risk.

ELSEVIER GLOBAL MEDICAL NEWS

NEW YORK — Overtreatment for low bone mass has been all too common in women aged 50–60 years since the introduction of the bisphosphonate drugs and the widespread use of bone scans, according to Dr. Stephen Honig.

Routine bone scanning at menopause—very common in this country—creates difficulties in treatment decisions for clinicians, because when low bone density is uncovered in the early postmenopausal years it generally is in the range of osteopenia, not osteoporosis.

“A common scenario has been a 50-year-old woman who has her last period, goes for a bone scan, and has a spinal T score of −2.2. She's given a prescription for Fosamax, and 10 years later she's still on the drug,” Dr. Honig said at a rheumatology meeting sponsored by New York University.

It's important to recognize that for women in the early years after menopause, a bone mineral density measurement does not provide the clinician with enough information to make appropriate treatment decisions.

What is needed is an understanding of an individual woman's risk of fracture in the short and intermediate term, balanced against the consequences of adverse events and the possibility of subtrochanteric fractures associated with excessive suppression of bone turnover.

“We want to avoid overtreating—too much drug, too soon, for too long—and of course we also want to avoid undertreating,” he said, adding that many women in their 60s and most women in their 70s can benefit from bone-strengthening therapy.

“For women in their 50s, however, what we really need to know is who is at risk for fracture, not just who has osteopenia,” said Dr. Honig of New York University, New York.

Fractures in women of this age are not simply a result of bone loss. Fractures occur when mechanical forces overcome the bone's capacity for resistance. This bone strength is dependent on structural and material properties of the bone, including size, shape, trabecular architecture, and mineral-to-matrix ratio.

Clearly, other factors also contribute. In the National Osteoporosis Risk Assessment (NORA), which included 200,160 women aged 50 years and older, factors significantly associated with fractures included low bone mineral density, poor health status, personal or family history of fracture, maternal history of osteoporosis, no current hormone replacement therapy, menopause before age 40, corticosteroid use, and current smoking.

Analysis of the NORA data also found that the most important determinants of 3-year fracture risk in women aged 50–64 years were prior fracture, T score at or below −1.1, and self-reported fair/poor health status, with fracture risks of 7.2%, 3.1%, and 2.4%, respectively (Osteoporos. Int. 2007;18:1287–96).

A further difference in fracture risk between women in the early postmenopausal years and those who are older is that the fracture of primary concern is not the hip, but the wrist/forearm. In the Danish Osteoporosis Prevention Study, 872 women whose mean age was 51 years were followed for 10 years.

During that time, 80 fractures occurred in 78 women. There were a total of 64 in the forearm, 8 in the spine, 7 in the proximal humerus, and only 1 in the hip (J. Bone Miner. Res. 2006;21:796–800).

Studies have shown that at menopause, the rate of falls among women begins to increase dramatically. In a study from the United Kingdom that analyzed 90,061 accidents, 38,737 were classified as “underfoot” (events such as slipping or tripping). Among women overall, 51% of accidents were underfoot, as were 32% of accidents in men, but after the age of 50 these numbers increased to 64% in women and 43% in men (Q. J. Med. 2001;94:699–707).

It turns out estrogen has a critical role in postural stability, Dr. Honig said. Declining estradiol levels are associated with decreasing ability to maintain balance, slower reaction and movement times, and lower muscle strength—all of which contribute to falling and injury.

“Most clinicians never give a second thought to the issue of balance in a 50-year-old woman,” Dr. Honig said.

Having a fall-related fracture also is a risk factor for an additional fracture. Longer-term follow-up of the NORA cohort found that over 3 years, a prior wrist fracture increased the risk of a future wrist fracture about threefold and doubled the risk of any osteoporotic fracture (Osteoporos. Int. 2008;19:607–13).

In conclusion, healthy young postmenopausal women with low bone mass and no recent fracture history have a low 1- to 3-year risk of fracturing, Dr. Honig said. For these patients, according to new 2008 guidelines from the National Osteoporosis Foundation, treatment should be initiated only if their 10-year hip fracture probability is 3% or greater or their 10-year all-fracture probability is 20% or greater, based on the U.S.-adapted World Health Organization absolute fracture risk model.

The guidelines are available on the Web site of the National Osteoporosis Foundation, at www.nof.orgwww.shef.ac.uk/FRAX

Dr. Honig serves on the speakers bureau of Novartis Pharmaceuticals Corp.

Subtrochanteric fracture is seen in a patient who had been on bisphosphonate therapy. BMD measurement alone may not accurately predict fracture risk.

ELSEVIER GLOBAL MEDICAL NEWS

SAN FRANCISCO — Women with osteoporosis treated with teriparatide often gain lumbar spine bone mineral density and lower their risk of vertebral fracture, even if they lose hip bone mineral density, Dr. Nelson B. Watts reported in a poster presentation at the annual meeting of the International Society for Clinical Densitometry.

Previous studies have shown that increased areal lumbar spine bone mineral density (BMD) accounts for 30%–41% of the reduction in vertebral fracture risk from teriparatide treatment. In clinical practice, loss of BMD in other areas, such as the femoral neck, has been viewed by some as a lack of response to therapy.

The current post hoc analysis of data on 1,216 women found vertebral fracture risk was independent of gains or losses in femoral neck BMD in women taking teriparatide, compared with women on placebo, reported Dr. Watts, program director of the bone health and osteoporosis center at the University of Cincinnati.

The investigators analyzed data on women with a history of vertebral fractures randomized to take 20 or 40 mcg/day of teriparatide or placebo in the double-blind Fracture Prevention Trial. The women self-administered the treatments subcutaneously and also received daily supplements of 1,000 mg of calcium and 400–1,200 IU of vitamin D.

The current analysis focused on a subset of 1,216 women who had femoral neck BMD measured both at baseline and after 12 months of therapy by dual-energy x-ray absorptiometry (DXA) and who had lateral thoracic and lumbar spine radiographs taken both at baseline and at the study end point, a median of 19 months from baseline.

The risk of vertebral fracture was calculated for women on placebo and for women in four subgroups of teriparatide therapy based on changes in femoral neck BMD 1 year from baseline. The women on teriparatide were divided as follows: those who lost more than 4% of femoral neck BMD, those who lost up to 4% in density, those who gained up to 4% in density, and those who gained more than 4% in femoral neck BMD.

In the combined teriparatide groups, a significantly greater proportion (35%) gained more than 4% in femoral neck BMD, compared with those on placebo (17%).

Women also showed significant reductions in vertebral fracture risk on teriparatide therapy, compared with placebo, regardless of changes in femoral neck BMD at 1 year, Dr. Watts reported.

Among women with greater than a 4% loss in femoral neck density, 2 (2%) of 82 women on teriparatide developed vertebral fractures, compared with 14 (23%) of 61 women on placebo. Among women with up to a 4% loss in femoral neck density, 5 (3%) of 182 women on teriparatide and 15 (10%) of 149 women on placebo developed vertebral fractures.

Among women with up to a 4% gain in femoral neck BMD, vertebral fractures were seen in 5 (3%) of 182 women on teriparatide and 19 (15%) of 124 women on placebo. Among women with greater than a 4% gain in femoral neck density, 14 (5%) of 282 on teriparatide and 9 (14%) of 66 on placebo developed vertebral fractures.

Lumbar spine BMD increased significantly more in women on teriparatide, compared with placebo, regardless of changes in femoral neck density. Lumbar spine density increased by 3% or greater in 78%–92% of women on teriparatide in the four femoral neck subgroups.

The study was funded by the maker of teriparatide, Eli Lilly & Co., which also provided the layout for the poster. Dr. Watts is a consultant for the company. His report was rated one of the top posters at the meeting.

In the combined teriparatide groups, 35% gained more than 4% in neck BMD versus 17% of those on placebo. DR. WATTS

SAN FRANCISCO — Women with osteoporosis treated with teriparatide often gain lumbar spine bone mineral density and lower their risk of vertebral fracture, even if they lose hip bone mineral density, Dr. Nelson B. Watts reported in a poster presentation at the annual meeting of the International Society for Clinical Densitometry.

Previous studies have shown that increased areal lumbar spine bone mineral density (BMD) accounts for 30%–41% of the reduction in vertebral fracture risk from teriparatide treatment. In clinical practice, loss of BMD in other areas, such as the femoral neck, has been viewed by some as a lack of response to therapy.

The current post hoc analysis of data on 1,216 women found vertebral fracture risk was independent of gains or losses in femoral neck BMD in women taking teriparatide, compared with women on placebo, reported Dr. Watts, program director of the bone health and osteoporosis center at the University of Cincinnati.

The investigators analyzed data on women with a history of vertebral fractures randomized to take 20 or 40 mcg/day of teriparatide or placebo in the double-blind Fracture Prevention Trial. The women self-administered the treatments subcutaneously and also received daily supplements of 1,000 mg of calcium and 400–1,200 IU of vitamin D.

The current analysis focused on a subset of 1,216 women who had femoral neck BMD measured both at baseline and after 12 months of therapy by dual-energy x-ray absorptiometry (DXA) and who had lateral thoracic and lumbar spine radiographs taken both at baseline and at the study end point, a median of 19 months from baseline.

The risk of vertebral fracture was calculated for women on placebo and for women in four subgroups of teriparatide therapy based on changes in femoral neck BMD 1 year from baseline. The women on teriparatide were divided as follows: those who lost more than 4% of femoral neck BMD, those who lost up to 4% in density, those who gained up to 4% in density, and those who gained more than 4% in femoral neck BMD.

In the combined teriparatide groups, a significantly greater proportion (35%) gained more than 4% in femoral neck BMD, compared with those on placebo (17%).

Women also showed significant reductions in vertebral fracture risk on teriparatide therapy, compared with placebo, regardless of changes in femoral neck BMD at 1 year, Dr. Watts reported.

Among women with greater than a 4% loss in femoral neck density, 2 (2%) of 82 women on teriparatide developed vertebral fractures, compared with 14 (23%) of 61 women on placebo. Among women with up to a 4% loss in femoral neck density, 5 (3%) of 182 women on teriparatide and 15 (10%) of 149 women on placebo developed vertebral fractures.

Among women with up to a 4% gain in femoral neck BMD, vertebral fractures were seen in 5 (3%) of 182 women on teriparatide and 19 (15%) of 124 women on placebo. Among women with greater than a 4% gain in femoral neck density, 14 (5%) of 282 on teriparatide and 9 (14%) of 66 on placebo developed vertebral fractures.

Lumbar spine BMD increased significantly more in women on teriparatide, compared with placebo, regardless of changes in femoral neck density. Lumbar spine density increased by 3% or greater in 78%–92% of women on teriparatide in the four femoral neck subgroups.

The study was funded by the maker of teriparatide, Eli Lilly & Co., which also provided the layout for the poster. Dr. Watts is a consultant for the company. His report was rated one of the top posters at the meeting.

In the combined teriparatide groups, 35% gained more than 4% in neck BMD versus 17% of those on placebo. DR. WATTS

SAN FRANCISCO — Women with osteoporosis treated with teriparatide often gain lumbar spine bone mineral density and lower their risk of vertebral fracture, even if they lose hip bone mineral density, Dr. Nelson B. Watts reported in a poster presentation at the annual meeting of the International Society for Clinical Densitometry.

Previous studies have shown that increased areal lumbar spine bone mineral density (BMD) accounts for 30%–41% of the reduction in vertebral fracture risk from teriparatide treatment. In clinical practice, loss of BMD in other areas, such as the femoral neck, has been viewed by some as a lack of response to therapy.

The current post hoc analysis of data on 1,216 women found vertebral fracture risk was independent of gains or losses in femoral neck BMD in women taking teriparatide, compared with women on placebo, reported Dr. Watts, program director of the bone health and osteoporosis center at the University of Cincinnati.

The investigators analyzed data on women with a history of vertebral fractures randomized to take 20 or 40 mcg/day of teriparatide or placebo in the double-blind Fracture Prevention Trial. The women self-administered the treatments subcutaneously and also received daily supplements of 1,000 mg of calcium and 400–1,200 IU of vitamin D.

The current analysis focused on a subset of 1,216 women who had femoral neck BMD measured both at baseline and after 12 months of therapy by dual-energy x-ray absorptiometry (DXA) and who had lateral thoracic and lumbar spine radiographs taken both at baseline and at the study end point, a median of 19 months from baseline.

The risk of vertebral fracture was calculated for women on placebo and for women in four subgroups of teriparatide therapy based on changes in femoral neck BMD 1 year from baseline. The women on teriparatide were divided as follows: those who lost more than 4% of femoral neck BMD, those who lost up to 4% in density, those who gained up to 4% in density, and those who gained more than 4% in femoral neck BMD.

In the combined teriparatide groups, a significantly greater proportion (35%) gained more than 4% in femoral neck BMD, compared with those on placebo (17%).

Women also showed significant reductions in vertebral fracture risk on teriparatide therapy, compared with placebo, regardless of changes in femoral neck BMD at 1 year, Dr. Watts reported.

Among women with greater than a 4% loss in femoral neck density, 2 (2%) of 82 women on teriparatide developed vertebral fractures, compared with 14 (23%) of 61 women on placebo. Among women with up to a 4% loss in femoral neck density, 5 (3%) of 182 women on teriparatide and 15 (10%) of 149 women on placebo developed vertebral fractures.

Among women with up to a 4% gain in femoral neck BMD, vertebral fractures were seen in 5 (3%) of 182 women on teriparatide and 19 (15%) of 124 women on placebo. Among women with greater than a 4% gain in femoral neck density, 14 (5%) of 282 on teriparatide and 9 (14%) of 66 on placebo developed vertebral fractures.

Lumbar spine BMD increased significantly more in women on teriparatide, compared with placebo, regardless of changes in femoral neck density. Lumbar spine density increased by 3% or greater in 78%–92% of women on teriparatide in the four femoral neck subgroups.

The study was funded by the maker of teriparatide, Eli Lilly & Co., which also provided the layout for the poster. Dr. Watts is a consultant for the company. His report was rated one of the top posters at the meeting.

In the combined teriparatide groups, 35% gained more than 4% in neck BMD versus 17% of those on placebo. DR. WATTS