CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 294 enrolled
Drug / intervention
Romosozumab 90 mg/mL +3 moredrug
Likely dose
Romosozumab 90 mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02016716
NCT02016716Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With Osteoporosis

Amgen·interventional·Posted Dec 20, 2013·Updated Nov 8, 2018

In Brief

A Phase 3 clinical trial evaluating Romosozumab 90 mg/mL, Placebo 90 mg/mL, and 2 other interventions for Postmenopausal Osteoporosis. Completed, enrolled 294 participants across 12 sites in 3 countries.

Detailed Summary

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesCzechia, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 20, 2013
Enrollment StartDec 3, 2013
Primary CompletionSep 8, 2014
Study CompletionDec 8, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.5 years ago

Interventions

Romosozumab 90 mg/mLdrug

Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).

Placebo 90 mg/mLdrug

Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.

Romosozumab 70 mg/mLdrug

Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.

Placebo 70 mg/mLdrug

Placebo administered as 3 SC injections with the 1.0 mL glass PFS.