Osteoporosis Postmenopausal Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK-0822 in the Treatment of Involutional Osteoporosis
The purpose of this study is to assess the dose-response on the percent change from baseline
in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when
odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52
weeks to Japanese involutional osteoporosis participants. The study will also assess safety
and tolerability of odanacatib (10, 25, and 50 mg) in these participants.
The study will enroll approximately 280 participants and randomly assign them to 3 different
doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium
carbonate. The primary efficacy hypothesis is that a dose-response relationship on the
percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50
mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis
participants. The primary safety hypothesis is that odanacatib will be safe and well
tolerated over 52 weeks to involutional osteoporosis participants.
n/a
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