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Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)

NCT00729183 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2018-08-27

Study results available
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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.

Conditions

Interventions

DRUG

Odanacatib

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

DRUG

Placebo

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

DRUG

Vitamin D3

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

DRUG

Calcium supplement

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-02
Primary Completion
2010-03-23
Completion
2011-03-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729183 on ClinicalTrials.gov