At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 332 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in 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.
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults With a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation
In Brief
A Phase 2 clinical trial evaluating Placebo and Romosozumab for Fracture Healing. Completed, enrolled 332 participants across 99 sites in 24 countries.
Detailed Summary
This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFracture Healing
CountriesArgentina, Australia, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Greece, Hong Kong, Hungary, India, Italy, Latvia, Lithuania, Netherlands, New Zealand, Poland, Slovenia, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartJun 2010
Primary CompletionJun 2012
Study CompletionMay 2013
TodayJul 2026
First PostedMar 5, 2010
Enrollment StartJun 20, 2010
Primary CompletionJun 30, 2012
Study CompletionMay 10, 2013
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 16.3 years ago
Interventions
Placebodrug
Administered by subcutaneous (under the skin) injection
Romosozumabdrug
Administered by subcutaneous injection