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The Alliance for Better Bone Health Responds to Fosamax(R) Actonel(R) Comparison Trial Results.

Publication: PR Newswire

Publication Date: 28-SEP-04
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COPYRIGHT 2004 PR Newswire Association LLC

BRIDGEWATER, N.J. and CINCINNATI, Sept. 28 /PRNewswire/ -- The Alliance for Better Bone Health announced its response to the results of Merck's bone mineral density (BMD) study released today.

"Bone mineral density (BMD) is important for determining if a patient needs therapy, but when determining which therapy, fracture reduction is the clinically relevant endpoint," says Dr. Nora Zorich, M.D., Ph.D., Head of Drug Development, P&G Pharmaceuticals. "If Merck had intended to fully compare efficacy, they would have run a head-to-head fracture trial."

Merck's own vice president of clinical research was quoted to this effect in response to another comparative BMD trial, "People can't interpret this kind of data without looking at longer-term fracture trials." The Alliance for Better Bone Health believes that this BMD trial should not be used as a head-to-head comparison of efficacy of osteoporosis treatments. In fact, Merck's own data for different doses of Fosamax(R) have shown markedly different effects on BMD, but similar effects on fracture.

The National Institutes of Health (NIH) states, "Fracture prevention is the primary goal in the treatment of osteoporosis." Many studies have shown that increases in BMD correlate poorly to fracture risk reduction. Using differences in BMD increases to compare the efficacy of different therapies...

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