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Risedronate (Actonel) Produces Significant and Rapid Decrease in Vertebral Fracture Risk in Postmenopausal Osteoporotic Women: Presented at ASBMR

By Jill Stein
Special to DG News

SAN ANTONIO, TX -- September 23, 2002 -- A 5 mg daily dose of the bisphosphonate risedronate (Actonel) significantly decreases the risk of moderate and severe vertebral fractures in postmenopausal women with osteoporosis, investigators reported at the 24^th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).

Prior to the present analysis, risedronate had been demonstrated to be effective in reducing morphometric vertebral fractures by 65 and 61 percent in the VERT- NA and VERT-MN clinical studies, respectively. In addition, risedronate had been shown to decrease the risk of clinical vertebral fractures as early as six months. The VERT-MN and VERT-MA are similarly designed multicenter, double-blind studies in which 1,994 postmenopausal women with osteoporosis were randomized to treatment with risedronate, 5 mg daily, or placebo; all patients received supplemental calcium along with vitamin D if baseline serum levels were low.

In the present analysis, Dr. Dieter Felsenberg, with the Benjamin Franklin University Hospital in Berlin, Germany, and colleagues elsewhere, analyzed data from the two trials in order to determine the vertebral fracture risk reduction with risedronate treatment on moderate or severe fractures during the first year of therapy.

During the first year, 46 (4.6 percent) of 992 placebo-treated patients sustained a new moderate or severe vertebral fracture versus only 14 of 1,002 (1.4 percent) patients in the risedronate group. In patients treated with the bisphosphonate, the risk reduction in moderate and severe vertebral fractures at one year was 70.7 percent.

The reductions in vertebral fracture risk were sustained over three years.

"The fundamental goal of treatment is to prevent fractures," co-investigator Dr. Harry Genant, professor of radiology, medicine, epidemiology, and orthopedic surgery at the University of California, San Francisco, said. "The new findings, coupled with earlier data documenting decreases in the risk of a first vertebral fracture and multiple vertebral fractures, suggest that risedronate decreases fracture risk across a range of osteoporotic severity."

The study was funded by the Alliance for Better Bone Health, a partnership between Procter & Gamble Pharmaceuticals and Aventis.

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