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

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ClinicalTrials.gov Identifier: NCT00907296
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : May 23, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Fracture Healing Drug: AMG 785 210mg Drug: AMG 785 70mg Drug: AMG 785 140 mg Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 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
Study Start Date : September 2009
Primary Completion Date : May 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AMG 785 dose group 5
Three doses of 140mg AMG 785
Drug: AMG 785 140 mg
140mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 3
Two doses of 70mg AMG 785
Drug: AMG 785 70mg
70mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 6
Two doses of 140mg AMG 785
Drug: AMG 785 140 mg
140mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 8
Three doses of 210mg AMG 785
Drug: AMG 785 210mg
210mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 7
Four doses of 210mg AMG 785
Drug: AMG 785 210mg
210mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 1
Four doses of 70mg AMG 785
Drug: AMG 785 70mg
70mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 2
Three doses of 70mg AMG 785
Drug: AMG 785 70mg
70mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 4
Four doses of 140mg AMG 785
Drug: AMG 785 140 mg
140mg AMG 785, subcutaneous (under the skin) injection
Experimental: AMG 785 dose group 9
Two doses of 210mg AMG 785
Drug: AMG 785 210mg
210mg AMG 785, subcutaneous (under the skin) injection
Placebo Comparator: Placebo arm
Four doses of placebo
Drug: Placebo
Placebo, subcutaneous (under the skin) injection


Outcome Measures

Primary Outcome Measures :
  1. Time to radiographic healing for the AMG 785 and placebo groups [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Physical functioning as measured by change from baseline in the SF-36 PF [ Time Frame: 52 weeks ]
  2. Subject incidence of revision surgery [ Time Frame: 52 weeks ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907296


  Show 103 Study Locations
Sponsors and Collaborators
Amgen
UCB Pharma
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00907296     History of Changes
Other Study ID Numbers: 20062017
2008-008392-34 ( EudraCT Number )
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by Amgen:
Fracture Healing
Tibial Diaphyseal Fracture

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries