Sanofi-aventis' and Procter & Gamble's osteoporosis drug Actonel (risedronate) garnered FDA approval to increase bone mass in men with osteoporosis.
The expanded approval was granted based on results from a clinical trial involving 284 men with osteoporosis who were randomised to receive either Actonel or placebo once-weekly. Results demonstrated that patients who received Actonel showed "statistically significant" improvements in both lumbar spine bone mineral density, and reductions in bone turnover markers, the companies noted in a statement.
In the US, Actonel is indicated to prevent and treat osteoporosis in postmenopausal women, and to prevent and treat certain forms of steroid-induced osteoporosis in both women and men, news sources report.
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