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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Cholecalciferol; Vitamin D

Criteria

Inclusion Criteria:

• Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85

• Participant who has low bone mineral density

• Participant has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumber spine and hip

• Participant is ambulatory (can walk)

Exclusion Criteria:

• Participant has secondary osteoporosis or has a metabolic bone disorder other than osteoporosis or osteopenia

• Participant has received osteoporosis medications or other medications that affect bone

• Participant is already participating in another drug study