Category: Healthy Bones

Risedronate for Men With Osteoporosis

On August 11, 2006, the FDA approved generic risedronate sodium tablets (Actonel, Procter & Gamble) 35 mg to increase bone mass in men with osteoporosis.

Actonel 5 mg was approved in 2000 for use in men and women to prevent and treat steroid-induced osteoporosis. Actonel 35 mg is also approved to prevent and treat osteoporosis in post-menopausal women.

The approval of Actonel for men with osteoporosis was based on a two-year, placebo-controlled, double-blind multi-center clinical trial. Patients treated with once-a-week Actonel 35 mg experienced statistically significant improvements in lumbar spine bone mineral density at six, 12, and 24 months.

Statistically significant reductions in bone turnover markers were also achieved at three, six, 12, and 24 months.

According to the National Osteoporosis Foundation, osteoporosis affects 2 million men in the U.S., and another 12 million are at risk for developing the disease. About 50% of osteoporosis cases in men are associated with aging; the other 50% of cases are secondary to oral steroid use, low testosterone levels, and heavy alcohol use. Men with age-related osteoporosis usually develop the disease later in life than women do.

Injectable Zoledronic Acid For Paget’s Disease

Paget's Disease

Reclast (zoledronic acid) injection (Novartis) has been approved as the first new treatment in nearly a decade for patients with Paget’s disease. It is given as a single 5-mg, 15-minute infusion; current oral therapies must be taken daily for up to six months.

Paget’s disease is a chronic, often painful bone disorder that causes abnormal bone growth and weak and brittle bones. Reclast attaches to bone and blocks excessive bone breakdown and rebalances the natural bone-remodeling process.

Reclast has been found to be more effective and faster-working than drug risedronate sodium (generic Actonel, Procter & Gamble), the current standard therapy for patients with Paget’s disease, and it offers a longer period of remission.

The injection has been approved in more than 50 countries as Aclasta, and it is being reviewed for the treatment of postmenopausal osteoporosis.

Zoledronic acid is also marketed as Zometa for use in oncology.