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A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)

NCT00529373 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16071

Last updated 2024-06-11

Study results available
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Summary

The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis. In a placebo-controlled extension of the base study, participants continued to receive the same blinded study medication for a total of up to 5 years of blinded study medication combined between the base study and the extension. After participants received 5 years of blinded study medication, they received open-label odanacatib through the end of the first extension. Participants were then invited to enroll in a second extension study in which they received open-label odanacatib for an additional 5 years. Two imaging substudies (PN032-Base/Extension and PN035) were conducted for participants in the MK-0822-018 Study. Additional safety information was collected for participants who discontinued from the base study or the blinded first extension in an observational follow-up study, MK-0822-083 (EudraCT number: 2007-002693-66) .

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

Odanacatib

50 mg tablet orally once weekly (OW)

DRUG

Placebo for Odanacatib

50 mg tablet orally OW

DIETARY_SUPPLEMENT

Vitamin D3

5600 IU orally OW

DIETARY_SUPPLEMENT

Calcium carbonate

If needed. Total daily calcium intake (from both dietary and supplemental sources) will be approximately 1200 mg but not to exceed 1600 mg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-13
Primary Completion
2012-11-14
Completion
2017-02-01
FDA Drug
Yes

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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 NCT00529373 on ClinicalTrials.gov