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A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)

NCT00960934 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2015-02-18

Study results available
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Summary

The purpose of this study was to identify an appropriate dose of

MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.

Conditions

Interventions

DRUG

MK-5442

MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.

DRUG

Placebo

Dose-matched oral placebo to MK-5442

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3, two 400 IU tablets daily throughout the study.

DIETARY_SUPPLEMENT

Calcium carbonate

Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

Sponsors & Collaborators

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
2009-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

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Entities

Drugs
Diseases
Companies

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 NCT00960934 on ClinicalTrials.gov