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MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)

NCT00996801 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2016-01-22

Study results available
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Summary

This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be achieved by switching to MK-5442 from an oral bisphosphonate in participants who have been receiving oral bisphosphonate therapy for at least 3 years.

Conditions

Interventions

DRUG

MK-5442

MK-5442 tablets (randomized to a dose of 5, 7.5, 10 or 15 mg) taken orally, once-daily, for 12 months

DRUG

Placebo to MK-5442

Matching placebo to MK-5442 taken orally, once-daily, for 12 months

DRUG

Alendronate Sodium

Alendronate tablets 70 mg, taken orally, once-weekly, for 12 months

DRUG

Vitamin D3

Vitamin D3 (cholecalciferol) administered orally, at a dose of 5600 IU (two tablets, 2800 IU each), once-weekly for 12 months

DRUG

Calcium carbonate

Participants who qualify (those who have a calcium intake of less than 1200 mg/day) will receive oral supplemental calcium carbonate, at a dose of either 400 mg or 500 mg, once-daily, for 12 months

DRUG

Placebo to Alendronate

Placebo to alendronate once-weekly for 12 months

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
2009-11-30
Primary Completion
2011-06-30
Completion
2011-06-30

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Diseases
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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 NCT00996801 on ClinicalTrials.gov