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UC researcher uses historical control group for new osteoporotic fracture analysis.(Actonel clinical trials conducted without a placebo control group)
2002 AUG 15 - (NewsRx.com & NewsRx.net) -- 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) for the treatment and prevention of osteoporosis in postmenopausal women, and thus did not have a placebo control group.
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 ...
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