The strength of evidence (high, moderate, low, insufficient evidence to determine benefits or risks) and strength of recommendations (strong, weak, I recommendation) are defined at the end of the "Major Recommendations" field.
Recommendation 1: American College of Physicians (ACP) recommends that clinicians offer pharmacologic treatment to men and women who have known osteoporosis and to those who have experienced fragility fractures (Grade: strong recommendation; high-quality evidence).
Good evidence supports the treatment of patients who have osteoporosis to prevent further loss of bone and to reduce the risk for initial or subsequent fracture. Randomized, controlled trials offer good evidence that, compared with placebo, alendronate, ibandronate, risedronate, calcitonin, teriparatide, and raloxifene prevent vertebral fractures. Evidence is also good that teriparatide prevents nonvertebral fractures compared with placebo and that risedronate and alendronate prevent both nonvertebral and hip fractures compared with placebo. Estrogen has been shown to be associated with reduced vertebral, nonvertebral, and hip fractures. The evidence on use of calcium with or without vitamin D is mixed, and the effectiveness is modest. Because most trials of other pharmacologic therapy included their use, ACP recommends adding calcium and vitamin D to osteoporosis treatment regimens. Evidence is insufficient to determine the appropriate duration of therapy.
Recommendation 2: ACP recommends that clinicians consider pharmacologic treatment for men and women who are at risk for developing osteoporosis (Grade: weak recommendation; moderate-quality evidence).
Evidence supports the treatment of selected patients who are at risk for osteoporosis but who do not have a T-score on dual x-ray absorptiometry (DXA) less than -2.5. Evidence supporting preventive treatment is stronger for patients who are at moderate risk for osteoporosis, which includes patients who have a T-score from -1.5 to -2.5, are receiving glucocorticoids, or are older than 62 years of age.
Factors that increase the risk for osteoporosis in men include age (>70 years), low body weight (body mass index <20 to 25 kg/m2), weight loss (>10% [compared with the usual young or adult weight or weight loss in recent years]), physical inactivity (no physical activities performed regularly, such as walking, climbing stairs, carrying weights, housework, or gardening), corticosteroid use, and androgen deprivation therapy. Risk factors for women include lower body weight, the single best predictor of low bone mineral density; smoking; weight loss; family history; decreased physical activity; alcohol or caffeine use; and low calcium and vitamin D intake. In certain circumstances, a single risk factor (for example, androgen deprivation therapy in men) is enough for clinicians to consider pharmacologic treatment.
Research groups are developing calculators, such as the World Health Organization's Fracture Risk Assessment Tool (available at www.shef.ac.uk/FRAX/ ), to predict the risk for osteoporotic fracture. Such tools will help guide both clinician and patient decisions.
Recommendation 3: ACP recommends that clinicians choose among pharmacologic treatment options for osteoporosis in men and women on the basis of an assessment of risk and benefits in individual patients (Grade: strong recommendation; moderate-quality evidence).
ACP recommends that the choice of therapy for patients who are candidates for pharmacologic treatment be guided by judgment of the risks, benefits, and adverse effects of drug options for each individual patient. Table 2 in the original guideline document summarizes the benefits and harms of pharmacologic agents for fracture risk. Because good-quality evidence shows that bisphosphonates reduce the risk for vertebral, nonvertebral, and hip fractures, they are reasonable options to consider as first-line therapy, particularly for patients who have a high risk for hip fracture. Evidence from head-to-head trials is insufficient to demonstrate the superiority of one bisphosphonate over another. Alendronate and risedronate have been studied more than other bisphosphonates (see Table 2 in the original guideline document). Ibandronate has not been shown to reduce nonvertebral or hip fractures, which may be an important consideration for some patients. In a recent trial, zoledronic acid administered to patients with a recent hip fracture reduced subsequent fracture and improved survival. Of the other agents available for treatment of osteoporosis, estrogen has efficacy for vertebral, nonvertebral, and hip fractures but is associated with other serious risks; calcitonin has not been demonstrated to reduce nonvertebral and hip fractures; and calcium and vitamin D are part of the treatment regimen in most studies of pharmacologic agents for osteoporosis.
Refer to the "Potential Harms" field of this summary for a discussion of adverse effects and other risks of pharmacologic therapy.
See the original guideline document for recommendations for further research.
|American College of Physicians' Guideline Grading System*
|Quality of Evidence
||Strength of Recommendation
||Benefits Clearly Outweigh Risks and Burden OR Risks and Burden Clearly Outweigh Benefits
||Benefits Finely Balanced with Risks and Burden
|Insufficient evidence to determine net benefits or risks
*Adopted from the classification developed by the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) workgroup.