CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 214 enrolled
Drug / intervention
Odanacatib +3 moredrug
Likely dose
Odanacatib 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00729183
NCT00729183Phase 3Completed
CompareCT.gov

A Phase III Randomized, Placebo-Controlled Study to Evaluate the Effect of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety, and to Estimate the Effect of Odanacatib (MK-0822) on Bone Micro-architecture in Postmenopausal Women Treated With Vitamin D

Merck Sharp & Dohme LLC·interventional·Posted Aug 7, 2008·Updated Aug 27, 2018

In Brief

A Phase 3 clinical trial evaluating Odanacatib, Placebo, and 2 other interventions for Osteoporosis. Completed, enrolled 214 participants.

Detailed Summary

This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine compared to placebo at 12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2008
Enrollment StartOct 2, 2008
Primary CompletionMar 23, 2010
Study CompletionMar 21, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.9 years ago

Interventions

Odanacatibdrug

Odanacatib 50 mg tablets, taken orally once weekly for 24 months.

Placebodrug

Matching placebo tablets to odanacatib taken orally once weekly for 24 months.

Vitamin D3drug

Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months.

Calcium supplementdrug

Calcium supplement 500 mg tablet taken orally once daily (up to \~1200 mg total) for 24 months.