Alendronate for osteoporosis. Safe and efficacious nonhormonal therapy.

OBJECTIVE: To review the evidence concerning alendronate (Fosamax) therapy for postmenopausal osteoporosis. QUALITY OF EVIDENCE: The efficacy of alendronate for postmenopausal women with osteoporosis was primarily demonstrated by two primary phase III clinical trials, three other 2-year trials, and one 3-year trial. All six trials were randomized double-blind placebo-controlled trials; 3854 postmenopausal women were studied. The Fracture Intervention Trial consisted of 2027 women with postmenopausal osteoporosis and provides the most evidence that 3 years of treatment with alendronate reduces all clinically relevant fractures, including hip fractures. MAIN FINDINGS: In postmenopausal women, alendronate has been shown to increase bone mineral density significantly at the lumbar spine, femoral neck, and trochanter and in the total body, regardless of baseline bone mineral density, age, bone turnover, or the presence of previous fractures. In addition, alendronate has been shown to reduce risk of new vertebral and hip fractures by about 50% and of all clinical fractures by about 30%. Continuous daily dosing with alendronate (10 mg) was found to be well tolerated. In addition, alendronate was shown to have no adverse effects on bone mineralization or microstructure. CONCLUSION: This evidence shows alendronate to be safe and effective; it should be considered the nonhormonal therapy of choice for treating osteoporosis in postmenopausal women at risk for hip and vertebral fractures.