On August 11, 2006, the FDA approved generic risedronate sodium tablets (Actonel, Procter & Gamble) 35 mg to increase bone mass in men with osteoporosis.
Actonel 5 mg was approved in 2000 for use in men and women to prevent and treat steroid-induced osteoporosis. Actonel 35 mg is also approved to prevent and treat osteoporosis in post-menopausal women.
The approval of Actonel for men with osteoporosis was based on a two-year, placebo-controlled, double-blind multi-center clinical trial. Patients treated with once-a-week Actonel 35 mg experienced statistically significant improvements in lumbar spine bone mineral density at six, 12, and 24 months.
Statistically significant reductions in bone turnover markers were also achieved at three, six, 12, and 24 months.
According to the National Osteoporosis Foundation, osteoporosis affects 2 million men in the U.S., and another 12 million are at risk for developing the disease. About 50% of osteoporosis cases in men are associated with aging; the other 50% of cases are secondary to oral steroid use, low testosterone levels, and heavy alcohol use. Men with age-related osteoporosis usually develop the disease later in life than women do.