Study Complete
Sponsor ID
20080394

Study To Assess FRacTure Healing with SclerosTin Antibody - HipSTARTT-Hip

Sponsor ID
20080394
Clinicaltrials.gov ID
NCT01081678
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 2
Product
AMG 785
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
332
Additional Study Details

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
Status
Contact Us
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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