Actonel Sanctioned for Male Osteoporosis

Already approved to increase bone mass in post-menopausal women

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MONDAY, Aug. 14, 2006 (HealthDay News) -- Actonel (risedronate sodium) has been approved by the U.S. Food and Drug Administration to treat osteoporosis in men, according to its manufacturers, Proctor & Gamble Pharmaceuticals and Sanofi-Aventis.

Already widely prescribed for osteoporosis in post-menopausal women, Actonel 35 mg. was approved for men based on a two-year study of 284 adult males with the soft-bones condition. Significant improvement was seen in lumber spine bone mineral density at 6, 12, and 24 months, the companies said in a statement.

According to statistics from the National Osteoporosis Foundation, 2 million men in the United States are already osteoporotic and another 12 million are at risk, the drugmakers said.

Most men who develop osteoporosis do so later in life -- usually later than women, the companies said. Half of male osteoporosis cases are associated with aging, and the rest are due to secondary causes such as oral steroid use, low levels of the male hormone testosterone, and heavy alcohol use.

Possible side effects of Actonel include constipation and back pain, the companies said.

More information

To learn more about osteoporosis, visit the U.S. National Institutes of Health.

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