Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
NCT00161629
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures | ||||||
| Official Title ICMJE | 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 | ||||||
| Brief Summary | 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment | ||||||
| Condition ICMJE | Radius Fractures | ||||||
| Intervention ICMJE | Drug: rhBMP-2/CPM | ||||||
| Study Arms ICMJE | Not Provided | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Estimated Enrollment ICMJE | 40 | ||||||
| Original Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | January 2007 | ||||||
| Primary Completion Date | Not Provided | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Other inclusion applies. Exclusion Criteria:
Other exclusion applies. | ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 50 Years to 80 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Finland, France | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00161629 | ||||||
| Other Study ID Numbers ICMJE | 3100N7-114 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Not Provided | ||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
| Verification Date | December 2007 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||