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Actonel significantly reduced moderate and severe vertebral fractures

San Antonio, TX (September 20, 2002) A new analysis of scientific data presented at today's meeting of the American Society for Bone and Mineral Research (ASBMR) showed that a 5 mg dose of Actonel (risedronate sodium tablets) daily significantly reduced moderate and severe vertebral fracture risk by 70 percent within one year in postmenopausal women with osteoporosis. Furthermore, the significant effect on vertebral fracture risk was sustained over three years.

This analysis combined data from two large Actonel clinical trials, VERT-NA and VERT-MN, which included postmenopausal women with either one prevalent vertebral fracture and low bone mineral density (BMD), or with at least two prevalent vertebral fractures. The objective of this analysis was to compare the incidence of moderate or severe vertebral fracture at one year in women who received Actonel or placebo. Fracture severity was determined using the fracture severity scoring system developed by Harry Genant, M.D., Professor of Radiology, Medicine, Epidemiology and Orthopaedic Surgery at the University of California, San Francisco, an investigator and pioneer of the assessment method used in the analysis.

Recent studies show severity of prevalent vertebral fractures is a predictor of future vertebral and non-vertebral fracture risk; patients with more severe baseline vertebral fractures are more likely to experience subsequent vertebral and non-vertebral fractures. Therefore, reducing the incidence of moderate or severe vertebral fractures may help decrease the risk of future fractures.

"The ultimate goal of osteoporosis treatment is to prevent fractures," said Dr. Genant, "These new findings, combined with previous Actonel clinical data showing reductions in both risk of first vertebral fracture and multiple vertebral fractures, suggest that Actonel reduces fracture risk across a range of osteoporotic severity."

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20-Sep-2002


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