Health Condition 1: null- Acceleration of fracture healing Health Condition 2: M844- Pathological fracture, not elsewhere classified
Conditions
Interventions
Intervention1: Drug: AMG 785 140 mg: AMG 785 dose group 2: Experimental
Four doses of 140mg AMG 785
All subjects received three SC injections per visit of double-blind AMG 785 or placebo
administer
Sponsors
Amgen
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Males and females, age 55 to 95 years Fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury Intertrochanteric fractures eligible for this study must have at least two displaced fragments Internal fixation of the intertrochanteric fracture with sliding hip screw or intramedullary nail Internal fixation of femoral neck fracture with either a sliding hip screw or at least three cancellous screws
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Major polytrauma or significant axial trauma 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 Inability to independently rise from armchair or walk 200 meters before hip fracture (use of unilateral assistive device or rolling walker is acceptable) Severe symptomatic osteoarthritis of the lower extremity Cognitive deficit or symptomatic neurological conditions such as Parkinsons disease or persistent gross motor or sensory deficits such as hemiparesis or hemiplegia Use of bone grafts at the time of fracture fixation Pathological fracture or metabolic or bone disease History of facial nerve paralysis or symptomatic spinal stenosis that has not been surgically corrected. If surgically corrected, the subject must be asymptomatic to be eligible for the study Malignancy within the last 5 years Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia, hypoalbuminemia Use of agents affecting bone metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. [ Designated as safety issue: No ]Timepoint: [ Time Frame: 20 weeks ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, vital signs, laboratory data, ECG parameters, formation of anti-AMG 785 antibodies [ Designated as safety issue: Yes ]Timepoint: [ Time Frame: 104 weeks ];Mean Harris Hip Score by visit [ Designated as safety issue: No ]Timepoint: [ Time Frame: 52 weeks ];Mean pain score as measured by the visual analog scale by visit [ Designated as safety issue: No ]Timepoint: [ Time Frame: 52 weeks ];Mean value for timed-up-and-go test by visit [ Designated as safety issue: No ]Timepoint: [ Time Frame: 52 weeks ];Time to radiographic healing [ Designated as safety issue: No ]Timepoint: [ Time Frame: 52 weeks ] | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Greece, Hungary, India, Italy, Latvia, Lithuania, Netherlands, New Zealand, Poland, Slovenia, Sweden, Switzerland, United Kingdom, United States of America
Contacts
Public ContactDr Veena Jaguste
Amgen Technology Pvt Ltd
Outcome results
None listed