Its manufacturers, Proctor and Gamble Pharmaceuticals and Sanofi-Aventis, say the drug is already commonly prescribed for the soft-bones condition in post-menopausal women.
The FDA approved Actonel 35 mg. for men based on a two-year study of 284 adult males with the disease.
The companies say in a statement that after the men were treated with the drug, significant improvement was seen in lumber spine bone mineral density at 6, 12, and 24 months.
The National Osteoporosis Foundation reports 2 million men in the United States already have the condition and another 12 million are at risk.
The companies say most men who develop osteoporosis get it when they are older.
Half of male osteoporosis cases are associated with aging. The remaining cases are a result of secondary causes, such as oral steroid use, low levels of testosterone and heavy use of alcohol.
Possible adverse effects of using Actonel are constipation and back pain.
