Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)
Status:
Completed
Trial end date:
2009-05-29
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Calcium Calcium Carbonate Calcium, Dietary Cholecalciferol Vitamin D