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

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00907296
First received: May 21, 2009
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Fracture Healing
Drug: AMG 785 210mg
Drug: AMG 785 70mg
Drug: AMG 785 140 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Time to radiographic healing for the AMG 785 and placebo groups [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 402
Study Start Date: September 2009
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907296

  Show 103 Study Locations
Sponsors and Collaborators
Amgen
UCB, Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00907296     History of Changes
Other Study ID Numbers: 20062017, 2008-008392-34
Study First Received: May 21, 2009
Last Updated: May 22, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Denmark: Danish Medicines Agency
European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization for Medicines
India: Central Drugs Standard Control Organization
Italy: Ministry of Health
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Romanian National Drug Agency
Russia: Ministry of Health
Slovakia: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Fracture Healing
Tibial Diaphyseal Fracture

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014