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Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

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NCT00161629

Last updated on November 16, 2019
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Study Location
Kuopio, , 70211 Finland
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Radius Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00161629
Pfizer
Completed
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

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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 SummaryTo 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 DescriptionNot 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
 (submitted: September 7, 2005)		40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Finland, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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