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In Brief: Metra Biosystems

This article was originally published in The Gray Sheet

Executive Summary

Metra Biosystems: Gains 510(k) clearance for the use of the Pyrilinks-D bone resorption immunoassay to monitor anti-resorptive therapies, including Merck's Fosamax (alendronate), in the treatment and prevention of osteoporosis. The clearance is based upon a randomized, placebo-controlled clinical trial conducted by Merck to demonstrate the efficacy of alendronate in postmenopausal women diagnosed with osteoporosis. First cleared by the FDA in December 1995 for measuring bone resorption, Pyrilinks-D was used in the Merck trial to compare Dpd levels in subjects who received either alendronate and a calcium supplement or a calcium supplement alone...
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