Phase 3 safety, efficacy data shows bone mineral increase in risedronate-treated male osteoporosis patients

By Lisa Kerner

Charlotte, N.C., June 5 - In a phase 3 trial evaluating the safety and efficacy of risedronate sodium tablets 35 mg for male osteoporosis, patients treated with risedronate experienced a statistically significant 4.5% increase in lumbar spine bone mineral density (LSBMD) compared with patients receiving a placebo after two years.

The study was sponsored by Sanofi-aventis U.S. (The Alliance for Better Bone Health) and Procter & Gamble Pharmaceuticals, with results presented at the International Osteoporosis Foundation World Congress on Osteoporosis.

The significant improvements in LSBMD were measured at six, 12 and 24 months. Reductions in bone turnover markers were measured at three, six, 12 and 24 months.

According to Sanofi-aventis, risedronate was well tolerated and adverse events were similar between patients receiving risedronate and patients receiving a placebo.

A total of 284 men (95% Caucasian) between the ages of 36 and 84 years with osteoporosis participated in the double-blind, placebo-controlled multi-center study.

Participants were randomized to either risedronate sodium tablets 35 mg once a week or a placebo and received daily supplements of calcium (1,000 mg) and vitamin D (400-500 IU) for two years.

The trial's primary endpoint was mean percent change from baseline in lumbar spine bond mineral density, with secondary endpoints including bone mineral density changes at the femoral neck, femoral trochanter and total proximal femur.

Located in Paris, Sanofi-aventis is a pharmaceutical company specializing in the therapeutic areas of cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines.

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