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Registration trials of bisphosphonates for preventing osteoporotic fractures have consistently shown good efficacy and safety profiles. However, the trial durations were 3 to 4 years — and long-term bisphosphonate use has been associated with rare cases of atypical femur fracture, osteonecrosis of the jaw, and perhaps esophageal cancer, raising questions about appropriate duration of therapy.
In two New England Journal of Medicine Perspectives, FDA authors and academic researchers analyzed findings on vertebral and nonvertebral fractures in two trials of extended bisphosphonate use. The trials involved postmenopausal osteoporotic women who:
Had received 5 years of daily alendronate and were then randomized to 5 additional years of treatment o…