drugset / Trial / NCT03432533

A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for Osteoporosis

NCT03432533

Phase 3 Completed 283 enrolled Amgen
RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start
2018-02-06
Primary completion
2019-04-11
Completion
2020-01-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Romosozumab Monoclonal antibody 210 mg Subcutaneous