Study of AMG 785 in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing - Full Text View

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:

MedlinePlus related topics: Fractures

Drug Information available for: Sodium polystyrene sulfonate

U.S. FDA Resources

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

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:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

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:	March 11, 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 May 16, 2013