At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 402 enrolled
Drug / intervention
Romosozumab +1 morebiological
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 of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail
In Brief
A Phase 2 clinical trial evaluating Romosozumab and Placebo for Fracture Healing. Completed, enrolled 402 participants across 103 sites in 23 countries.
Detailed Summary
The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFracture Healing
CountriesAustralia, Bulgaria, Canada, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Latvia, Lithuania, Mexico, New Zealand, Norway, Poland, Romania, Russia, Slovakia, United Kingdom, United States
CollaboratorsUCB Pharma
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartSep 2009
Primary CompletionMar 2012
Study CompletionMay 2013
TodayJul 2026
First PostedMay 22, 2009
Enrollment StartSep 2, 2009
Primary CompletionMar 6, 2012
Study CompletionMay 10, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.1 years ago
Interventions
Romosozumabbiological
Administered by subcutaneous injection
Placebodrug
Administered by subcutaneous injection