Treatment for Osteoprosis in Men Approved by FDA
The U.S. Food and Drug Administration recently approved risedronate sodium (Actonel®) tablets 35 mg once a week for the treatment of osteoporosis in men. Actonel had been previously approved for the prevention and treatment of osteoporosis in postmenopausal women as well as for the prevention and treatment of osteoporosis that results from long-term use of steroid medications in both men and women.
The approval of Actonel for men is based on a two-year, placebo-controlled, double-blind clinical trial of 284 adult men with osteoporosis. Men who were treated with Actonel 35 mg once per week experienced significant improvements in lumbar spine bone mineral density, as well as significant reductions in bone turnover markers which measured rates of bone remodeling. High rate of bone remodeling may be associated with worsening osteoporosis. Adverse effects were generally similar between men receiving Actonel and men receiving placebo and included constipation and back pain.
Two million men in the U.S. already have osteoporosis, and another 12 million are at risk. Most osteoporotic men develop the disease later in life and at older ages than women. Half of the men diagnosed with osteoporosis have age-related bone loss. With an aging population and increasing life expectancy, age-related cases of male osteoporosis are expected to increase. Most of the rest of the men with this disease have secondary osteoporosis which is caused by factors such as oral steroid use, low levels of testosterone (hypogonadism), excessive alcohol use and certain underlying disease such as rheumatoid arthritis and inflammatory bowels.
Actonel is a product of Proctor & Gamble Pharmaceuticals and sanofi-aventis U.S., and is marketed by the Alliance for Better Bone Health. The toll-free Proctor & Gamble Pharmaceuticals customer service number is (800) 448-4878.
Source for this article:
"Tips for Fall Prevention" National Osteoporosis Foundation, Standing Tall for You, Volume 21, Number 4, page 7.
