A Phase 2/3 Multicenter, Controlled Trial of rhBMP-2/CPM in Tibial Fractures - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00387686

Purpose

The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.

Condition	Intervention	Phase
Fractures	Drug: rhBMP-2/CPM	Phase II Phase III

MedlinePlus related topics: Fractures

Drug Information available for: Calcium gluconate Calcium phosphate Dibotermin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Official Title:	A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) in Closed Diaphyseal Tibial Fracture

Further study details as provided by Wyeth:

Primary Outcome Measures:

The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered in combination with the SOC accelerates fracture union and return to normal function as indicated on radiographs and functional evaluations. [ Time Frame: efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fracture union and time to FWB without pain between either of the active treatment groups and the SOC control group ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 1.0 mg/mL rhBMP-2/CPM + surgical fixation	Drug: rhBMP-2/CPM
B: Experimental 2.0 mg/mL rhBMP-2/CPM + surgical fixation	Drug: rhBMP-2/CPM
C: Active Comparator Buffer/CPM + surgical fixation Intervention	Drug: rhBMP-2/CPM
D Standard of Care: Surgical fixation intervention	Drug: rhBMP-2/CPM

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Skeletally mature, male and female subjects who are at least 18 years old.
Closed diaphyseal tibial fracture.
Closed reduction and definitive internal fixation by means of a reamed, locked intramedullary nail within 72 hours after injury.

Exclusion Criteria:

Concurrent fractures of the ipsilateral or contralateral lower extremity other than the ipsilateral fibula, that would impede performance on the functional assessment of weight bearing.
Planned procedure(s) to stimulate fracture healing after intramedullary nailing.
Neurovascular impairment of the fractured limb, deep vein thrombosis, or (impending) compartment syndrome.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387686

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 64 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Brazil, xavierl@wyeth.com
Principal Investigator:	Trial Manager	For Mexico, gomezzlj@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3100N7-210
Study First Received:	October 11, 2006
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00387686
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Leg Injuries
Tibial Fractures

ClinicalTrials.gov processed this record on January 16, 2009