Experience with alendronate treatment for 7 years among Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures.

A retrospective study was performed to evaluate the outcome of alendronate treatment for 7 years among Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures. Thirty-five Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures (mean age at baseline 58.2 years) who had been treated with alendronate for over 7 years in our outpatient clinic were analyzed. The lumbar spine or total hip bone mineral density (BMD) was measured using dual energy X-ray absorptiometry; the urinary levels of cross-linked N-terminal telopeptides of type I collagen (NTX) and the serum levels of alkaline phosphatase (ALP) were monitored; the incidence of fractures during the 7-year treatment period was then assessed. The urinary NTX and serum ALP levels decreased (-46.1% at 3 months and -21.1% at 7 years, respectively) and the lumbar spine and total hip BMD increased (+14.2 and +10.1% at 7 years, respectively), compared with the baseline values. Four patients (11.4%) experienced vertebral fractures, and one patient (2.9%) experienced a nonvertebral fracture. No serious adverse events were observed, including osteonecrosis of the jaw or atypical femoral fractures. These results suggested that alendronate suppressed bone turnover and increased the lumbar spine and total hip BMD from the baseline values over the course of the 7-year treatment period without causing any severe adverse events in Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures.