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Actonel reduced nonveterbral fracture as early as 6 months

Further evidence of rapid fracture benefits with Actonel

San Francisco, Calif. (June 19, 2002) A new analysis shows Actonel (risedronate sodium tablets) reduced the risk of nonvertebral osteoporotic fractures by 74 percent within one year in postmenopausal women with osteoporosis. A significant reduction in the risk of nonvertebral fractures was observed as soon as six months. The effect of Actonel on nonvertebral fracture risk was based on a combined endpoint of the following sites: wrist, humerus, hip, pelvis, leg, and clavicle. The data were presented this week at the 84th Annual Meeting of The Endocrine Society in San Francisco.

"The ultimate goal of osteoporosis therapy is to prevent fractures," said J. T. Harrington, M.D., Associate Professor, Department of Medicine, University of Wisconsin Medical School, Madison, WI who was a lead investigator and presented the results today in a plenary session. "These study findings, combined with the consistent 1 year vertebral fracture reductions from previously published Actonel clinical trials, provide support for the rapid fracture benefits that Actonel provides across the skeleton."

The combined analysis included 1172 postmenopausal women with a lumbar spine T-score < -2.5 which is the World Health Organization (WHO) definition of osteoporosis. All patients received 1000 mg/d calcium in addition to either placebo or Actonel 5 mg daily. Nonvertebral fractures were collected as adverse events in three-month intervals and confirmed via x-ray. There was a statistically significant reduction in the risk of nonvertebral fractures as early as six months with a 74 percent reduction at one year (p=0.001, absolute risk reduction 3.3 percent).

According to the World Health Organization (WHO), osteoporosis is a significant and growing public health problem. The National Osteoporosis Foundation estimates that, in the United States, approximately 40 percent of women over 50 w
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Contact: Brian Devenny
bdevenny@hillandknowlton.com
212-885-0315
Hill and Knowlton
21-Jun-2002


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