A phase 2 clincial study to evaluate safety and efficacy of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail
- Conditions
- Health Condition 1: null- Fracture HealingHealth Condition 2: M844- Pathological fracture, not elsewhere classified
- Registration Number
- CTRI/2009/091/001044
- Lead Sponsor
- Amgen Technology Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria:
Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates
Fresh unilateral closed or Gustilo type I or type II open tibial fracture
Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing
Exclusion Criteria:
Major polytrauma or significant axial trauma
Associated lower extremity fracture that will delay subjects ability to bear weight beyond the normal time expected for a tibial shaft fracture
Use of bone grafts at the time of fracture fixation
Pathological fracture or metabolic or bone disease
History of symptomatic spinal stenosis or facial nerve paralysis
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
Use of agents affecting bone metabolism
Subject refuses to use appropriate methods of contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to radiographic healing for the AMG 785 and placebo groupsTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]<br>
- Secondary Outcome Measures
Name Time Method - Physical functioning as measured by change from baseline in the SF-36 PFTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]<br>;-Adverse events, vital signs, laboratory data, ECG parameters, formation of anti-AMG 785 antibodies, change in lumbar spine bone mineral density, long-term effect on radiographic healing and callus size and qualityTimepoint: [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]<br>;-Subject incidence of revision surgeryTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]<br>;-Time to clinical healing as determined by the ability to bear weight on the fractured limb and the absence of pain at the fracture siteTimepoint: [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]<br>