CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 294 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/NCT01120600
NCT01120600Phase 3Completed
CompareCT.gov

A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium

Merck Sharp & Dohme LLC·interventional·Posted May 11, 2010·Updated Aug 28, 2018

In Brief

A Phase 3 clinical trial evaluating Odanacatib, Placebo for Odanacatib, and 2 other interventions for Osteoporosis. Completed, enrolled 294 participants.

Detailed Summary

The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2010
Enrollment StartJun 9, 2010
Primary CompletionJul 22, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.1 years ago

Interventions

Odanacatibdrug

One 50 mg tablet once weekly

Placebo for Odanacatibdrug

One 50 mg tablet once weekly

Vitamin D3dietary

5600 IU of open-label Vitamin D3 once weekly

Calcium carbonatedietary

Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg