At a glance
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A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab Via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab Via Prefilled Syringe
In Brief
A Phase 3 clinical trial evaluating romosozumab HCP administration with PFS and romosozumab self-administration with AI/Pen for Post-Menopausal Osteoporosis. Completed, enrolled 283 participants across 46 sites in 3 countries.
Detailed Summary
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)
Study Details
Timeline
Interventions
210 mg romosozumab SC QM by HCP administration with 2 PFS
210 mg romosozumab SC QM by self-administration with 2 AI/Pens