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Merck's odanacatib increased BMD over 2 years at key fracture sites in Phase IIB study
Date:9/16/2008

WHITEHOUSE STATION, N.J., Sept. 16, 2008 Two-year data from a Phase IIB study of odanacatib (formerly MK-0822), an investigational, selective cathepsin-K inhibitor in development for the treatment of osteoporosis by Merck & Co., Inc., demonstrated dose- dependent increases in bone mineral density (BMD) at the total hip, lumbar spine and femoral neck fracture sites and decreased indices of bone resorption compared to placebo in postmenopausal women with low BMD. The results were reported today at the 30th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).

"Significant BMD increases were seen in the second year of treatment with odanacatib and these 24-month results confirm the positive increases seen at earlier timepoints," said Dr. Michael McClung, study investigator and director of the Oregon Osteoporosis Center in Portland, Oregon. "These data reinforce the potential of odanacatib as a novel treatment option for osteoporosis."

Odanacatib selectively inhibits the cathepsin K enzyme believed to play a central role in osteoclastic bone resorption, particularly in the degradation of the protein component of bone. Inhibition of cathepsin K is a novel approach to the treatment of osteoporosis that differs from those of currently approved treatments.

About the study

The multi-center, double-blind, randomized, placebo-controlled study evaluated doses of 3, 10, 25 or 50 mg of odanacatib administered orally, once-weekly and without regard to the timing of meals or the patient's physical position in 399 postmenopausal women with low BMD (T-scores equal to or less than -2.0 but equal to or greater than -3.5) for 24 months. Participants were provided with 5600 IU weekly, supplemental vitamin D, and 500 mg daily calcium carbonate was given to women with average daily calcium intakes of less than 1000 mg from all sources. The primary study endpoint was the LS mean change in BMD from baseline at the l
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Contact: Ron Rogers
908-423-6449
Merck & Co., Inc.
Source:Eurekalert

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