Study Complete
Sponsor ID
20080394
Study To Assess FRacTure Healing with SclerosTin Antibody - HipSTARTT-Hip
Study Details
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.
Protocol Summary
Primary Outcome Measures
Functional healing as measured by the mean value for the timed-up-and-go test over weeks 6 to 20 for the AMG 785 and placebo groups
Timeframe: 20 weeks
Secondary Outcome Measures
Mean value for timed-up-and-go test by visit
Timeframe: 52 weeks
Time to radiographic healing
Timeframe: 52 weeks
Mean Harris Hip Score by visit
Timeframe: 52 weeks
Mean pain score as measured by the visual analog scale by visit
Timeframe: 52 weeks
Radiographic Union Scale for Hip score by visit
Timeframe: 52 weeks
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Liverpool, NSW, Australia, 2170
Status
Recruiting
Location
Research Site
Footscray, VIC, Australia, 3011
Status
Completed
Location
Research Site
Genk, Belgium, 3600
Status
Recruiting
Location
Research Site
Brugge, Belgium, 8000
Status
Recruiting
Location
Research Site
Liege, Belgium, 4000
Status
Completed
Location
Research Site
Leuven, Belgium, 3000
Status
Recruiting
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