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Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Oral Bisphosphonate (MK-0822-076)

NCT01803607 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2019-09-04

Study results available
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Summary

The purpose of this study is to assess to what extent sequential treatment with odanacatib results in incremental gains in bone mineral density (BMD) over time in female participants who have received at least 3 years of bisphosphonate therapy. It was hypothesized that odanacatib treatment would increase femoral neck BMD relative to placebo after 24 months.

Conditions

Interventions

DRUG

odanacatib

odanacatib 50 mg oral tablet

OTHER

placebo to odanacatib

dose-matched placebo to odanacatib, oral tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-14
Primary Completion
2014-11-11
Completion
2014-11-11

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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 NCT01803607 on ClinicalTrials.gov