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UC researcher utilizes historical control group for new osteoporatic fracture analysis

Cincinnati, Ohio, June 19, 2002 In a new analysis of a study funded by Procter & Gamble Pharmaceuticals, Nelson Watts, MD, professor of medicine at the University of Cincinnati (UC) and director of the UC Bone Health and Osteoporosis Center, has applied an innovative new method for analyzing fracture efficacy for an osteoporosis therapy in a study that was conducted without a placebo control group. The original study was intended to compare two different dose forms of Actonel (risedronate sodium tablets), a new 35 mg a new once a week dose to the 5 mg daily dose, for the treatment and prevention of osteoporosis in postmenopausal women, and thus did not have a placebo control group. Dr. Watts constructed a historical placebo control group from patients in previous Actonel trials to evaluate fracture reduction efficacy of Actonel 35 mg once-a-week. The use of a historical placebo control helps address ethical concerns associated with giving a placebo to clinical trial participants when proven treatments are available in a therapeutic area.

The data, which was presented at the 84th Annual Meeting of the Endocrine Society in San Francisco, represents the first published analysis of fracture reduction using historical placebo control with an osteoporosis therapy. The novel analysis suggests that once a week treatment with Actonel reduced the risk of new vertebral fractures at one year by 77 percent in postmenopausal women. As previously reported, once-a-week treatment with Actonel 35 mg has been found to increase bone mineral density similarly to Actonel 5 mg at one year. Actonel 35 mg once a week was recently approved by the FDA for the treatment and prevention of osteoporosis in postmenopausal women.

"Historical controls have been used in therapeutic areas such as oncology and surgery; however, we are only beginning to make use of this approach in osteoporosis studies," said Dr. Watts. Using statistical methodology, Dr. Watts and his colleagu
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Contact: Brian Devenny
bdevenny@hillandknowlton.com
212-885-0315
Hill and Knowlton
21-Jun-2002


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