Study To Assess FRacTure Healing With SclerosTin Antibody - Hip (NCT01081678) | Clinical Trial Compass
CompletedPhase 2
Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
United States332 participantsStarted 2010-06-20
Plain-language 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.
Who can participate
Age range55 Years – 95 Years
SexALL
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Inclusion Criteria:
* Males and females, age 55 to 95 years
* fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury, confirmed by X-ray and in the opinion of the treating surgeon amenable to repair by internal fixation
* internal fixation of the fracture with devices approved by local regulatory agency, performed no later than 7 days after injury for intertrochanteric or undisplaced femoral neck fractures and no later than 2 days after injury for displaced femoral neck fractures
* intertrochanteric fracture: sliding hip screw or IM nail
* femoral neck fracture: sliding hip screw or at least 3 cancellous screws
Exclusion Criteria:
* severe symptomatic osteoarthritis of the lower extremity
* inability to independently rise from armchair or walk 200 meters before hip fracture
* presence of concomitant injuries such as rib fractures, wrist fractures, or acute symptomatic vertebral fractures which severely impair the ability to rise from a chair
* associated extremity injuries including ipsilateral or contralateral fractures of the foot, tibia or fibula, wrist, humerus, femoral shaft, femoral head or hip dislocation, that may delay weight-bearing beyond one week after surgery
* head-injury, as defined by Glasgow Coma Scale \< 13 prior to randomization
* use of bone grafts or bone substitutes at the time of fracture fixation
* major polytrauma or significant axial trauma, with Injury Severity Score \> 16
* pathological fracture or hist…