Experience with alendronate treatment for four years among Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures

PURPOSE: A retrospective study based on a conventional medical practice was performed to evaluate the outcome of alendronate treatment for four years in Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures. METHODS: Twenty-nine Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures (mean age at baseline 61.0 years) who had been treated with alendronate for over four years in our outpatient clinic were studied. Lumbar spine or total hip bone mineral density (BMD) was measured using dual energy x-ray absorptiometry, and urinary levels of cross-linked N-terminal telopeptides of type I collagen (NTX) and serum levels of bone-specific alkaline phosphatase were monitored during the four-year treatment period. RESULTS: Urinary NTX and serum bone-specific alkaline phosphatase levels decreased (−44.4% at three months and −61.2% at four years, respectively) and lumbar spine and total hip BMD increased (+13.9% and +9.2% at four years, respectively), compared with baseline values. No serious adverse events were observed, including osteonecrosis of the jaw, femoral diaphysis atypical fractures, or atrial fibrillation. CONCLUSION: To our knowledge, this is the first report of the outcome of alendronate treatment for four years in Japanese men with an increased risk for fractures. Alendronate suppressed bone turnover and increased lumbar spine and total hip BMD from baseline over the course of the four-year treatment period without causing any severe adverse events in Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures.