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Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
This study has been completed.
Study NCT00161629   Information provided by Wyeth
First Received: September 1, 2005   Last Updated: December 3, 2007   History of Changes

September 1, 2005
December 3, 2007
September 2005
 
Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
Same as current
Complete list of historical versions of study NCT00161629 on ClinicalTrials.gov Archive Site
Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.
Same as current
 
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
A Phase 1 Dose-Escalating, Double-Blind, Placebo-Controlled, Multicenter, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy for Closed Distal Radius Fractures

To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.

 
Phase I
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Radius Fractures
Drug: rhBMP-2/CPM
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
January 2007
 

Inclusion Criteria:

  • Adults aged 50 to 80 years of age; alert and oriented to person, place, and time.
  • Acute, closed distal radius fractures (within 4 cm of the tip of the radial styloid process), classified according to AO/ASIF as either A2 or A3 (extra-articular) or C1 or C2 (intra-articular) fractures.
  • Closed fracture reduction and definitive fracture fixation performed within 7 days after injury by means of external skeletal and/or percutaneous pin fixation. Note: fractures that are initially treated by closed reduction and casting, then converted to external or percutaneous pin fixation for definitive fracture fixation within 7 days after injury are eligible for the study.

Other inclusion applies.

Exclusion Criteria:

  • Other fractures of the ipsilateral upper extremity (except for ulnar styloid fractures) or the contralateral upper extremity (except for previously healed fractures without residual functional deficit).
  • Fracture fixation by other means (eg, plate and screw fixation).
  • Planned treatment for the fracture includes any procedure to promote fracture healing (eg, open reduction internal fixation, bone grafting, non-invasive modalities such as ultrasound, electrical stimulation, etc). Note: After 12 weeks have elapsed since administration of the treatment assignment, unanticipated procedures to promote fracture healing are permitted as clinically indicated.

Other exclusion applies.

Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland,   France
 
NCT00161629
 
3100N7-114
Wyeth
 
Study Director: Medical Monitor Wyeth
Principal Investigator: Trial Manager For Finland, MedInfoNord@wyeth.com
Wyeth
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP