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Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

NCT01552122 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-08-27

No results posted yet for this study

Summary

This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.

Conditions

Interventions

DRUG

Odanacatib

Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months

DRUG

Alendronate

Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.

OTHER

Placebo (odanacatib)

One compressed tablet administered orally, once-a-week, for 24 months.

DIETARY_SUPPLEMENT

Cholecalciferol (Vitamin D3)

Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.

DIETARY_SUPPLEMENT

Calcium carbonate

Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.

OTHER

Placebo (alendronate)

One compressed tablet administered orally, once-a-week, for 24 months.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

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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 NCT01552122 on ClinicalTrials.gov