Clinical trial NCT00387686: A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Fractures
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: efficacy will be demonstrated if there is a greater than or equal to 4 week reduction in time to fra
Secondary outcomes:
measure: Demonstrate safety of rhBMP-2/CPM administration; demonstrate earlier return to function; assess feasibility of rhBMP-2CPM administration. Subject enrollment 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Pinellas Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Wayne
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Portage
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Elmhurst
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Liverpool
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: New Lambton
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Cerequeira Cesar
country: Brazil
facility: Pfizer Investigational Site
state: Sao Paolo
city: Vila Clemetino
country: Brazil
facility: Pfizer Investigational Site
state: Sao Paulo
city: Ajax
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Angers
country: France
facility: Pfizer Investigational Site
city: Créteil
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Mangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Col. Los Morales
country: Mexico
facility: Pfizer Investigational Site
state: Del Miguel, Hidalgo
city: Col. el Retiro
country: Mexico
facility: Pfizer Investigational Site
state: Guadalajara, Jal.
city: Mexico City
country: Mexico
facility: Pfizer Investigational Site
state: Mexico D.F.
city: Chihuahua
country: Mexico
facility: Pfizer Investigational Site
city: Guadalajara, Jal
country: Mexico
facility: Pfizer Investigational Site
city: Bielsk Podlaski
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
state: Cluj
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Iasi
country: Romania
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Nis
country: Serbia
facility: Pfizer Investigational Site
city: Ljubljana
country: Slovenia
facility: Pfizer Investigational Site
city: Alcala de Henares
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Alcala
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: Norwich
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: