Procter & Gamble (CINCINNATI, OH) and sanofi-aventis (BRIDGEWATER, NJ) announced that the US FDA approved Actonel® (risedronate sodium tablets) 35 mg for treatment to increase bone mass in men with osteoporosis. Actonel is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. The approval of Actonel for men with osteoporosis is based on a 2-year, placebo-controlled, double-blind, multi-center clinical trial of 284 male patients with osteoporosis. In the trial, patients treated with once-a-week Actonel 35 mg experienced statistically significant improvements in lumbar spine bone mineral density at all time points measured, 6, 12, and 24 months. Likewise, statistically significant reductions in bone turnover markers were achieved at all time points measured, 3, 6, 12, and 24 months.

Previously approved by the FDA, Actonel 5 mg/d and 35 mg once-a-week are indicated for the prevention and treatment of postmenopausal osteoporosis in women. Actonel 5 mg daily is indicated for the prevention and treatment of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (greater than or equal to 7.5 mg/d prednisone or equivalent) for chronic diseases.

According to the National Osteoporosis Foundation, osteoporosis affects 2 million men in the US, and another 12 million are at risk for developing the disease.

Approximately half of male osteoporosis cases are associated with aging. Men with age-related osteoporosis usually develop the disease later in life than do women. The other half of all male osteoporosis cases are due to secondary causes such as oral steroid use, low testosterone (hypogonadism), and heavy alcohol use.