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A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

NCT00885170 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2018-08-28

Study results available
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Summary

The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.

Conditions

Interventions

DRUG

Odanacatib

Odanacatib 50 mg tablets once weekly for 24 months

DRUG

Placebo

Placebo to odanacatib 50 mg tablets once weekly for 24 months

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months

DIETARY_SUPPLEMENT

Calcium

Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · 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
2009-04-13
Primary Completion
2011-09-15
Completion
2011-09-15

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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 NCT00885170 on ClinicalTrials.gov