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New analysis shows early intervention with Actonel reduces first vertebral fracture risk

Cincinnati, Ohio; Bridgewater, N.J. (June 20, 2002) Postmenopausal women with low spinal bone mineral density (BMD) and no previous history of vertebral fracture, who received Actonel (risedronate sodium tablets) 5 mg daily for up to three years, were 75 percent less likely to experience a first vertebral fracture than women in the control group, according to a new analysis. Published in the June issue of the journal Osteoporosis International, the results confirm the fracture reduction efficacy of Actonel in patients without vertebral fractures.

Vertebral fractures are among the most common osteoporotic fractures. In the U.S., an estimated 700,000 vertebral fractures occur every year. Data show that among postmenopausal women who sustain a vertebral fracture, one out of five will suffer their next vertebral fracture within just one year, potentially leading to a fracture cascade.

"Osteoporosis, long considered a slow developing disease, can actually progress quickly once a fracture occurs. The ability to prevent a first fracture is crucial for clinicians in the fight against osteoporosis. This is extremely important since osteoporosis affects more than 10 million people in the U.S.," said Robert Heaney, MD, of Creighton University in Omaha, Nebraska. "This 75 percent reduction in the risk of first fracture helps confirm that Actonel is a clinically significant treatment for postmenopausal women with osteoporosis."

The analysis assessed the risk of the first vertebral fracture in 640 postmenopausal women enrolled in four previously reported studies. The women had low lumbar spine BMD (T score <-2.5) and no vertebral fractures at baseline. The Actonel 5 mg daily, placebo-controlled studies ranged in duration from 1.5 to 3 years.

First vertebral fractures were observed in only 2.6 percent of the women who received Actonel 5 mg daily compared to 9.4 percent in the control group (which translates to a 75 percent risk fracture r
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20-Jun-2002


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