NCT00620113

Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK-0822 in the Treatment of Involutional Osteoporosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis Postmenopausal

Interventions

Type	Name	Description
DRUG	Odanacatib	Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
DIETARY_SUPPLEMENT	Vitamin D3	Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
DIETARY_SUPPLEMENT	Calcium carbonate	Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
DRUG	Placebo	Dose-matched placebo tablets to odanacatib, taken orally once weekly for 52 weeks.

Timeline

• Start date: 2007-12-03
• Primary completion: 2009-05-29
• Completion: 2009-05-29
• First posted: 2008-02-21
• Last updated: 2018-08-27
• Results posted: 2017-03-13