A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)

NCT01120600 ↗

Phase 3 Completed 294 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2010-06-09
Primary completion: 2013-07-22
Completion: 2013-07-22

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Odanacatib 50 mg Once Weekly: 6.86 (6.08 to 7.64) Percentage change NCT01120600 ↗

registry analysis (superiority or other test); Odanacatib 50 mg Once Weekly vs Placebo Once Weekly; p < 0.001 NCT01120600 ↗

Publications

Binkley N, Orwoll E, Chapurlat R, Langdahl BL, Scott BB, Giezek H, Santora AC. Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis. Osteoporos Int. 2021 Jan;32(1):173-184. doi: 10.1007/s00198-020-05701-9. Epub 2020 Nov 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Odanacatib	Small molecule	50 mg	Oral