Untreated postmenopausal women with osteoporosis

BOSTON (April 28, 2004) Results of a new analysis found that, without treatment, one out of 13 postmenopausal osteoporotic women who were initially fracture-free were likely to experience a spinal fracture within one year. This risk of fracture was present despite these patients taking supplemental calcium, and if necessary, Vitamin D. Data were presented today at the annual meeting of the American Association of Clinical Endocrinologists (AACE).

Additionally, a statistical model was presented that predicted the progression over time of subsequent spinal fractures in a population of osteoporotic women who were initially fracture-free. The model was based upon data from the placebo arms of Phase III fracture trials for Actonel (risedronate sodium tablets), and it included data for 2,326 patients whose fracture status (i.e. number of spinal fractures) was assessed at baseline and at yearly intervals. The model showed that the prevalence of spinal fractures rapidly increased over time if the population of osteoporotic women was not treated, and projected that therapy which reduced the risk of a first fracture within one year could substantially reduce the risk of future fracture.

"We previously established in another analysis that a postmenopausal osteoporotic woman who has already suffered a spinal fracture has a one in five risk of having another spinal fracture within one year; therefore, intervening before that first fracture occurs is important," said Dr. Robert Lindsay, Chief of Internal Medicine at Helen Hayes Hospital, West Haverstraw, NY and principal investigator on this study. "With one in 13 osteoporotic women at risk of that first spinal fracture within the year, choosing a therapy proven to act rapidly is important."

About the Analysis
Data for the analysis were from patients in the placebo arms of the Actonel fracture trials (VERT-MN, VERT-NA, HIP). The women had lumbar spine or femoral neck bone mineral de


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