Study of AMG 785 in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing


Tracking Information

Start Date  ICMJEJuly 2009
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: May 21, 2009)		Time to radiographic healing for the AMG 785 and placebo groups [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00907296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: May 21, 2009)
  • Physical functioning as measured by change from baseline in the SF-36 PF [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Subject incidence of revision surgery [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to clinical healing as determined by the ability to bear weight on the fractured limb and the absence of pain at the fracture site [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 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 quality [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy of AMG 785 in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
Official Title  ICMJEA Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail
Brief Summary

This is an international, multi-center, randomized, double blind, placebo controlled study of AMG 785 in skeletally mature adults with a fresh unilateral tibial diaphyseal fracture status post a definitive fracture fixation with an intramedullary (IM) nail. The primary hypothesis for this study is that AMG 785 compared with placebo is effective in reducing radiographic healing time of fresh tibial diaphyseal fractures.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEFracture Healing
Intervention  ICMJE
  • Drug: AMG 785 70mg
    70mg AMG 785, subcutaneous (under the skin) injection
  • Drug: AMG 785 210mg
    210mg AMG 785, subcutaneous (under the skin) injection
  • Drug: AMG 785 140 mg
    140mg AMG 785, subcutaneous (under the skin) injection
  • Drug: Placebo
    Placebo, subcutaneous (under the skin) injection
Study Arms / Comparison Groups
  • AMG 785 dose group 5: Experimental
    Three doses of 140mg AMG 785
    Intervention: Drug: AMG 785 140 mg
  • AMG 785 dose group 3: Experimental
    Two doses of 70mg AMG 785
    Intervention: Drug: AMG 785 70mg
  • AMG 785 dose group 6: Experimental
    Two doses of 140mg AMG 785
    Intervention: Drug: AMG 785 140 mg
  • AMG 785 dose group 8: Experimental
    Three doses of 210mg AMG 785
    Intervention: Drug: AMG 785 210mg
  • AMG 785 dose group 7: Experimental
    Four doses of 210mg AMG 785
    Intervention: Drug: AMG 785 210mg
  • AMG 785 dose group 1: Experimental
    Four doses of 70mg AMG 785
    Intervention: Drug: AMG 785 70mg
  • AMG 785 dose group 2: Experimental
    Three doses of 70mg AMG 785
    Intervention: Drug: AMG 785 70mg
  • AMG 785 dose group 4: Experimental
    Four doses of 140mg AMG 785
    Intervention: Drug: AMG 785 140 mg
  • AMG 785 dose group 9: Experimental
    Two doses of 210mg AMG 785
    Intervention: Drug: AMG 785 210mg
  • Placebo arm: Placebo Comparator
    Four doses of placebo
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE400
Estimated Completion DateNovember 2012
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 subject's 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 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, hypoalbuminemia
  • Use of agents affecting bone metabolism
  • Subject refuses to use appropriate methods of contraception
GenderBoth
Ages18 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Amgen Call Center866-572-6436
Location Countries  ICMJEUnited States,   Australia,   Canada,   Denmark,   France,   Greece,   Italy,   Latvia,   New Zealand,   Poland,   Russian Federation,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00907296
Responsible PartyGlobal Development Leader, Amgen Inc.
Study ID Numbers  ICMJE20062017
Study Sponsor  ICMJEAmgen
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:MDAmgen
Information Provided ByAmgen