At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2/3, Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Once-monthly Oral Administration of NE-58095DR Tablet (25 mg or 37.5 mg) Versus Once-daily Oral Administration of NE-58095IR Tablet (2.5 mg) for the Treatment of Involutional Osteoporosis
In Brief
A Phase 3 clinical trial evaluating NE-58095 IR, NE-58095 IR Placebo, and 2 other interventions for Involutional Osteoporosis. Completed, enrolled 871 participants across 25 sites.
Detailed Summary
The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5 mg tablets once daily for 12 months are set as the control group.
Study Details
Timeline
Interventions
NE-58095 IR tablets
NE-58095 IR placebo-matching tablets
NE-58095 DR tablets
NE-58095 DR placebo-matching tablets