At a glance
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A Phase IIb, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate
In Brief
A Phase 2 clinical trial evaluating MK-5442, Placebo to MK-5442, and 4 other interventions for Osteoporosis and Postmenopausal Osteoporosis. Completed, enrolled 526 participants.
Detailed 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.
Study Details
Timeline
Interventions
MK-5442 tablets (randomized to a dose of 5, 7.5, 10 or 15 mg) taken orally, once-daily, for 12 months
Matching placebo to MK-5442 taken orally, once-daily, for 12 months
Alendronate tablets 70 mg, taken orally, once-weekly, for 12 months
Vitamin D3 (cholecalciferol) administered orally, at a dose of 5600 IU (two tablets, 2800 IU each), once-weekly for 12 months
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
Placebo to alendronate once-weekly for 12 months