February 25, 2008 — On February 21, the National Osteoporosis Foundation (NOF) issued guidelines intended as a reference for clinicians in diagnosing and treating osteoporosis in men 50 years and older and in postmenopausal women. A recent study in the February 22 online issue of Osteoporosis International also highlights the use of the World Health Organization (WHO) fracture risk algorithm.“Osteoporosis is a silent disease until it is complicated by fractures - fractures that can occur following minimal trauma,” write NOF chair Bess Dawson-Hughes, MD, from Tufts University in Boston, Massachusetts, and colleagues. “These fractures are common and place an enormous medical and personal burden on aging individuals and a major economic toll on the nation. . . . Prevention, detection, and treatment of osteoporosis should be a mandate of primary care providers.”

The guidelines note that osteoporosis can be prevented; it can be detected and treated before any fracture occurs; and even after the first fracture has occurred, effective treatment options exist to reduce the risk for additional fractures.

These updated recommendations discuss prevention, risk assessment, diagnosis, and treatment of osteoporosis in postmenopausal women and in men who are at least 50 years of age. The statement also provides indications for performing bone densitometry as well as fracture risk thresholds mandating pharmacologic intervention.

“Since the NOF first published the guide in 1999, it has become increasingly clear that many patients are not being given appropriate information about prevention; many patients are not having appropriate testing to diagnose osteoporosis or establish osteoporosis risk; and, once diagnosed (by testing or by the occurrence of a fracture), too many patients are not being prescribed any of the FDA-approved, effective therapies,” the authors of the guidelines write.

Specific recommendations for clinicians managing postmenopausal women and men 50 years and older are as follows:

• Advise patients concerning the risk for osteoporosis and related fractures.
• Evaluate patients for secondary causes of osteoporosis.
• Advise patients regarding sufficient intake of calcium (at least 1200 mg/day, including supplements if necessary) and vitamin D (800 - 1000 IU/day of vitamin D3 for individuals who are at risk for inadequate intake).
• Suggest regular exercise, with both weight-bearing and muscle-strengthening activities, to decrease the risk for falls and fractures.
• Encourage patients to quit smoking and reduce excessive alcohol consumption.
• Prescribe bone mineral density (BMD) testing for women 65 years and older and men 70 years and older.
• Prescribe BMD testing for postmenopausal women and for men aged 50 to 70 years in whom the risk factor profile suggests cause for concern.
• Prescribe BMD testing to determine degree of disease severity for patients who have sustained a fracture.
• Begin treatment in patients with hip or vertebral (clinical or morphometric) fractures.
• After appropriate evaluation, begin treatment in patients in whom dual-energy x-ray absorptiometry (DXA) shows BMD T-scores of less than –2.5 at the femoral neck, total hip, or spine.
• Begin treatment in postmenopausal women and in men 50 years and older who have low bone mass or osteopenia with a T-score of –1 to –2.5 at the femoral neck, total hip, or spine and who have 10-year hip fracture probability of 3% or more or a 10-year all major osteoporosis–related fracture probability of 20% or more based on the US-adapted WHO absolute fracture risk model.
• For the prevention and treatment of osteoporosis, pharmacologic options currently approved by the US Food and Drug Administration (FDA) are bisphosphonates (alendronate, ibandronate, risedronate, and zoledronate), calcitonin, estrogens or hormone therapy, raloxifene, and parathyroid hormone (PTH 1-34).
• To monitor bone loss, perform BMD testing every 2 years at DXA centers with use of accepted quality assurance measures. Patients receiving pharmacologic intervention should have BMD testing 2 years after starting therapy and every 2 years thereafter.

Although much is known about the prevention, diagnosis, and treatment of osteoporosis in postmenopausal women and in men 50 years and older with use of widely available diagnostic and treatment methods, there are unanswered questions in urgent need of epidemiologic, clinical, and economic research. These are as follows:

• How can bone strength be evaluated more effectively with noninvasive technologies to improve identification of patients at high risk for fracture?
• Can the WHO algorithm be expanded to include information on spine BMD?
• How can peak bone mass be maximized in children, adolescents, and young adults?
• What are optimal parameters (type, intensity, duration, frequency) of an effective exercise program for the prevention and treatment of osteoporosis?
• How can risk factors for falling be identified and modified, and what would be the magnitude of effect on fracture risk?
• How effective are various FDA-approved treatments in preventing fractures in patients who have moderately low bone mass?
• What approaches could most effectively treat osteoporosis in disabled populations?
• What is the optimal duration of treatment with antiresorptive therapies, and what are the long-term adverse effects that are currently unrecognized?
• How useful are combination therapies, and what are the best drug combinations and timing for their use?
• Will agents be developed to significantly increase bone mass and normalize bone structure?

“The NOF is committed to continuing the effort to answer these and other questions related to this debilitating disease, with the goal of eliminating osteoporosis as a threat to the health of present and future generations,” the authors conclude.

A contemporaneous publication in Osteoporosis International notes that application of the WHO fracture prediction algorithm, along with an updated US economic analysis, suggests that osteoporosis treatment is cost-effective in patients with fragility fractures or osteoporosis, in older individuals at average risk, and in younger persons with additional clinical risk factors for fracture. Based on their analysis, the authors therefore endorse existing practice recommendations.

The authors of the NOF guidelines have disclosed no relevant financial relationships.

National Osteoporosis Foundation. Published online February 21, 2008. http://www.nof.org. Osteopor Int. Published online February 22, 2008.

Clinical Context

Osteoporosis, the most prevalent bone disease, is characterized by low bone mass, deterioration of bone tissue, decreased bone strength, and increased risk for fracture. The WHO criterion for osteoporosis is a BMD at the hip or spine that is 2.5 or less SDs below the young normal mean reference population.

Fractures and their associated morbidity are the most important complications of osteoporosis. These occur most often in the spine, proximal part of the femur, and wrist, and can lead to full recovery or to chronic pain, disability, psychologic sequelae, and even death. It is therefore essential that primary care providers be knowledgeable in the prevention, risk assessment, detection, and treatment of osteoporosis.

Study Highlights

• The NOF guidelines assert that osteoporosis can be prevented and can be diagnosed and treated even before fracture occurs and that there are effective treatment options to lower the risk for subsequent fracture even after the first fracture has occurred.
• These updated guidelines address prevention, risk assessment, diagnosis, and treatment of osteoporosis in postmenopausal women and in men who are at least 50 years of age.
• Specific recommendations for clinicians treating these patient groups are as follows:
  • Advise patients regarding the risk for osteoporosis and secondary fractures.
  • Rule out secondary causes of osteoporosis (eg, rheumatoid arthritis).
  • Encourage patients to consume sufficient calcium (≥1200 mg/day, including supplements if necessary) and vitamin D (800 - 1000 IU/day of vitamin D3 for those at risk for inadequate intake).
  • Suggest regular weight-bearing and muscle-strengthening exercise to decrease fall and fracture risks.
  • Urge patients to stop smoking and to decrease excessive alcohol intake.
  • Prescribe BMD testing for women 65 years and older and for men 70 years and older, regardless of clinical risk factors.
  • Prescribe BMD testing for younger postmenopausal women and for men 50 to 70 years old with elevated risk factor profile.
  • Prescribe BMD testing to determine degree of disease severity for patients who have sustained a fracture after age 50 years.
  • Other indications for BMD testing may include a condition such as rheumatoid arthritis or use of glucocorticoid or other medication associated with low bone mass or bone loss, consideration of pharmacotherapy for osteoporosis, monitoring of treatment effect, and postmenopausal women discontinuing estrogen.
  • Begin treatment in patients with hip or vertebral (clinical or morphometric) fractures.
  • Begin treatment, after appropriate evaluation, in patients with BMD T-scores of less than –2.5 on DXA at the femoral neck, total hip, or spine.
  • Begin treatment in postmenopausal women and in men 50 years or older with low bone mass or osteopenia (T-score –1 to –2.5 at the femoral neck, total hip, or spine) and with 10-year hip fracture probability of 3% or more or a 10-year all major osteoporosis–related fracture probability of 20% or more based on the US-adapted WHO absolute fracture risk model.
• The WHO absolute fracture risk model includes current age, use of oral glucocorticoid therapy, sex, secondary osteoporosis, personal or parental history of hip fracture, femoral neck BMD, current smoking, low body mass index, and alcohol intake of 3 or more drinks/day.
• Bisphosphonates (alendronate, ibandronate, risedronate, and zoledronate), calcitonin, estrogens or hormone therapy, raloxifene, and PTH 1-34 are currently FDA-approved therapies for osteoporosis prevention and treatment.
• The antifracture benefits of these drugs have primarily been studied in women with postmenopausal osteoporosis and for bisphosphonates, only with daily administration. There are no fracture data in men and limited fracture data in glucocorticoid osteoporosis.
• Perform BMD testing to monitor bone loss every 2 years at DXA centers with use of accepted quality assurance measures. Patients receiving pharmacotherapy should have BMD testing 2 years after starting therapy and every 2 years thereafter.
• Physical medicine and rehabilitation may reduce disability, improve physical function and activities of daily living, and decrease risk for subsequent falls in patients with osteoporosis.

Pearls for Practice

• BMD should be prescribed for women 65 years and older and for men 70 years and older, for younger postmenopausal women and for men ages 50 to 70 years in whom the risk factor profile suggests cause for concern, for patients older than 50 years or with known osteoporosis who have sustained a fracture, and for monitoring of bone loss and the effects of pharmacotherapy.
• Indications for treatment of osteoporosis are hip or vertebral fractures; BMD T-scores of less than –2.5 on DXA at the femoral neck, total hip, or spine; postmenopausal women and men 50 years and older with low bone mass or osteopenia (T-score –1 to –2.5 at the femoral neck, total hip, or spine) and with 10-year hip fracture probability of 3% or more, or a 10-year all major osteoporosis–related fracture probability of 20% or more based on the US-adapted WHO absolute fracture risk model.

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