Actonel Approved for Broader Use in Men With Osteoporosis

16/08/06 On August 11, 2006, the U.S. Food and Drug Administration (FDA) approved Actonel (risedronate sodium tablets) 35 mg for treatment to increase bone mass in men with osteoporosis, Procter & Gamble reported. FDA approval of this new indication for Actonel opens the door for more men with osteoporosis to benefit from Actonel treatment. Actonel 5 mg was approved in 2000 for use in men and women to prevent and treat certain forms of steroid-induced osteoporosis. Actonel 35 mg is also approved for the prevention and treatment of osteoporosis in postmenopausal women.

The approval of Actonel for men with osteoporosis is based on a two-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. Actonel was well tolerated, and adverse events were generally similar between patients receiving Actonel and patients receiving placebo. The most commonly reported adverse events were constipation, back pain, arthralgia, influenza, and nasopharyngitis.

"Male osteoporosis is a serious health concern," said Paul Miller, M.D., Director of the Colorado Center for Bone Research and Clinical Professor of Medicine at the University of Colorado Medical Center in Denver. "The approval of Actonel for men with osteoporosis provides physicians with a new treatment option."

According to the National Osteoporosis Foundation, osteoporosis affects two million men in the U.S., 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. With an aging population and increasing life expectancy, age- related cases of male osteoporosis are expected to increase. 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.

P & G said that Actonel 5 mg daily and 35 mg once a week are indicated for the prevention and treatment of postmenopausal osteoporosis in women. Actonel 35 mg once a week is indicated to increase bone mass in men with osteoporosis. 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. In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).