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A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004)

NCT00112437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2018-01-24

Study results available
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Summary

This is a 1-year base study with a 1-year extension to examine the effects of a new experimental medication (odanacatib \[MK-0822\]) on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of odanacatib or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsies (at the end of 2 years).

Conditions

Interventions

DRUG

Odanacatib

Odanacatib 3 mg, once weekly for 24 months

DRUG

Odanacatib

Odanacatib 10 mg, once weekly for 24 months

DRUG

Odanacatib

Odanacatib 25 mg, once weekly for 24 months

DRUG

Odanacatib

Odanacatib 50 mg, once weekly for 24 months

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3, two 2800 IU weekly throughout the study

DIETARY_SUPPLEMENT

Calcium Carbonate

Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium.

DRUG

Placebo

Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

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
2005-06-24
Primary Completion
2007-12-26
Completion
2016-01-20
FDA Drug
Yes

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Entities

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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 NCT00112437 on ClinicalTrials.gov