FRAX, Vitamin D Considered Key to Osteoporosis Care

The FRAX tool to calculate the risk of major osteoporotic fracture and recommendations increasing vitamin D₃ intake are key components of the North American Menopause Society's updated position statement on the management of osteoporosis in postmenopausal women.

Last updated in 2006, the 2010 statement (www.menopause.org/aboutmeno/consensus.aspx

Among the new recommendations is the use of the World Health Organization's FRAX (Fracture Risk Assessment) tool to calculate a patient's 10-year risk of major osteoporotic fracture (hip, shoulder, wrist, and spine). Developed by researchers led by Dr. John A. Kanis of the University of Sheffield (England), FRAX is based on individual patient models that integrate the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck. “People have been intimidated by the language associated with bone density reports over the years,” Dr. Steven T. Harris, a member of the editorial board that drafted the updated position statement, said in an interview. “It's distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number—some reasonable estimate of fracture risk—is very helpful.”

Dr. Utian, a member of the 2008-2009 NAMS Board of Trustees who reviewed the position statement, said that FRAX was included because clinicians have come to realize “some of the limitations of DXA and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”

According to the statement, drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture; BMD values consistent with osteoporosis (a T score of −2.5 or lower); or a T score from −1.0 to −2.5 and a 10-year FRAX risk of major osteoporotic fracture (hip, shoulder, wrist, and spine) of at least 20% or hip fracture of at least 3%.

Another new part of the NAMS statement recommends that postmenopausal women obtain 800-1,000 IU/day of vitamin D₃, up from the recommended dosage of 400-600 IU/day contained in the 2006 statement. “There is more and more evidence that even in temperate areas, there isn't enough sun exposure to guarantee vitamin D sufficiency, particularly during the winter months,” said Dr. Harris of the University of California, San Francisco. “I think that the recommended allowance of 800-1,000 IU/day will be increased again at some point, but I think it's a reasonable starting point.”

As for choice of a specific osteoporosis therapy, the statement emphasizes that no head-to-head trials comparing the effectiveness of pharmacologic therapies to reduce fracture risk have been conducted. Current approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.

According to the statement, bisphosphonates “are the first-line drugs for treating postmenopausal women with osteoporosis. They have reduced the risk of vertebral fractures by 40%-70% and reduced the incidence of nonvertebral fracture, including hip fracture, by about half this amount.”

The SERM raloxifene “prevents bone loss and reduces the risk of vertebral fractures, but its effectiveness in reducing other fractures is uncertain. Extraskeletal risks and benefits are important when considering raloxifene therapy.”

Disclosures: The development of the statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US. Dr. Utian and Dr. Harris disclosed relationships with multiple pharmaceutical firms.

The FRAX tool to calculate the risk of major osteoporotic fracture and recommendations increasing vitamin D₃ intake are key components of the North American Menopause Society's updated position statement on the management of osteoporosis in postmenopausal women.

Last updated in 2006, the 2010 statement (www.menopause.org/aboutmeno/consensus.aspx

Among the new recommendations is the use of the World Health Organization's FRAX (Fracture Risk Assessment) tool to calculate a patient's 10-year risk of major osteoporotic fracture (hip, shoulder, wrist, and spine). Developed by researchers led by Dr. John A. Kanis of the University of Sheffield (England), FRAX is based on individual patient models that integrate the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck. “People have been intimidated by the language associated with bone density reports over the years,” Dr. Steven T. Harris, a member of the editorial board that drafted the updated position statement, said in an interview. “It's distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number—some reasonable estimate of fracture risk—is very helpful.”

Dr. Utian, a member of the 2008-2009 NAMS Board of Trustees who reviewed the position statement, said that FRAX was included because clinicians have come to realize “some of the limitations of DXA and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”

According to the statement, drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture; BMD values consistent with osteoporosis (a T score of −2.5 or lower); or a T score from −1.0 to −2.5 and a 10-year FRAX risk of major osteoporotic fracture (hip, shoulder, wrist, and spine) of at least 20% or hip fracture of at least 3%.

Another new part of the NAMS statement recommends that postmenopausal women obtain 800-1,000 IU/day of vitamin D₃, up from the recommended dosage of 400-600 IU/day contained in the 2006 statement. “There is more and more evidence that even in temperate areas, there isn't enough sun exposure to guarantee vitamin D sufficiency, particularly during the winter months,” said Dr. Harris of the University of California, San Francisco. “I think that the recommended allowance of 800-1,000 IU/day will be increased again at some point, but I think it's a reasonable starting point.”

As for choice of a specific osteoporosis therapy, the statement emphasizes that no head-to-head trials comparing the effectiveness of pharmacologic therapies to reduce fracture risk have been conducted. Current approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.

According to the statement, bisphosphonates “are the first-line drugs for treating postmenopausal women with osteoporosis. They have reduced the risk of vertebral fractures by 40%-70% and reduced the incidence of nonvertebral fracture, including hip fracture, by about half this amount.”

The SERM raloxifene “prevents bone loss and reduces the risk of vertebral fractures, but its effectiveness in reducing other fractures is uncertain. Extraskeletal risks and benefits are important when considering raloxifene therapy.”

Disclosures: The development of the statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US. Dr. Utian and Dr. Harris disclosed relationships with multiple pharmaceutical firms.

The FRAX tool to calculate the risk of major osteoporotic fracture and recommendations increasing vitamin D₃ intake are key components of the North American Menopause Society's updated position statement on the management of osteoporosis in postmenopausal women.

Last updated in 2006, the 2010 statement (www.menopause.org/aboutmeno/consensus.aspx

Among the new recommendations is the use of the World Health Organization's FRAX (Fracture Risk Assessment) tool to calculate a patient's 10-year risk of major osteoporotic fracture (hip, shoulder, wrist, and spine). Developed by researchers led by Dr. John A. Kanis of the University of Sheffield (England), FRAX is based on individual patient models that integrate the fracture risks associated with clinical risk factors as well as bone mineral density at the femoral neck. “People have been intimidated by the language associated with bone density reports over the years,” Dr. Steven T. Harris, a member of the editorial board that drafted the updated position statement, said in an interview. “It's distressing to be told that you have osteopenia or osteoporosis. To be able to use the FRAX tool to reduce that to a number—some reasonable estimate of fracture risk—is very helpful.”

Dr. Utian, a member of the 2008-2009 NAMS Board of Trustees who reviewed the position statement, said that FRAX was included because clinicians have come to realize “some of the limitations of DXA and the overuse of DXA, which could lead to inappropriate therapies. While DXA is a valuable tool, the FRAX gives you an ability to speak to individuals and actually give them an idea of what their risk is. It also gives health care organizations the ability to set parameters at what level of risk they would consider therapy to be indicated.”

According to the statement, drug therapy is indicated for postmenopausal women with osteoporotic vertebral or hip fracture; BMD values consistent with osteoporosis (a T score of −2.5 or lower); or a T score from −1.0 to −2.5 and a 10-year FRAX risk of major osteoporotic fracture (hip, shoulder, wrist, and spine) of at least 20% or hip fracture of at least 3%.

Another new part of the NAMS statement recommends that postmenopausal women obtain 800-1,000 IU/day of vitamin D₃, up from the recommended dosage of 400-600 IU/day contained in the 2006 statement. “There is more and more evidence that even in temperate areas, there isn't enough sun exposure to guarantee vitamin D sufficiency, particularly during the winter months,” said Dr. Harris of the University of California, San Francisco. “I think that the recommended allowance of 800-1,000 IU/day will be increased again at some point, but I think it's a reasonable starting point.”

As for choice of a specific osteoporosis therapy, the statement emphasizes that no head-to-head trials comparing the effectiveness of pharmacologic therapies to reduce fracture risk have been conducted. Current approved treatment options include bisphosphonates, selective estrogen-receptor modulators (SERMs), parathyroid hormone, estrogens, and calcitonin.

According to the statement, bisphosphonates “are the first-line drugs for treating postmenopausal women with osteoporosis. They have reduced the risk of vertebral fractures by 40%-70% and reduced the incidence of nonvertebral fracture, including hip fracture, by about half this amount.”

The SERM raloxifene “prevents bone loss and reduces the risk of vertebral fractures, but its effectiveness in reducing other fractures is uncertain. Extraskeletal risks and benefits are important when considering raloxifene therapy.”

Disclosures: The development of the statement was supported by an unrestricted educational grant from the Alliance for Better Bone Health, a collaboration between Warner Chilcott and its affiliates and Sanofi-Aventis US. Dr. Utian and Dr. Harris disclosed relationships with multiple pharmaceutical firms.