At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIa Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate
In Brief
A Phase 2 clinical trial evaluating Odanacatib, Placebo, and 2 other interventions for Osteoporosis. Completed, enrolled 246 participants.
Detailed Summary
The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.
Study Details
Timeline
Interventions
Odanacatib 50 mg tablets once weekly for 24 months
Placebo to odanacatib 50 mg tablets once weekly for 24 months
Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months
Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.