Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00243295
First received: October 19, 2005
Last updated: October 5, 2006
Last verified: October 2006
  Purpose

To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:

  • Injecting the desired volume of rhBMP-2/CPM within the defect
  • Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.

Condition Intervention Phase
Osteoarthritis
Drug: rhBMP-2/CPM
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) in Subjects With Open Wedge Osteotomies

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies
  • Feasibility measures include
  • Injection of desired volume of rhBMP-2/CPM within the osteotomy defect
  • Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.

Secondary Outcome Measures:
  • Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial.

Estimated Enrollment: 6
Study Start Date: November 2003
Estimated Study Completion Date: March 2005
  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects 45 to 70 years of age
  • Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee.
  • Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study.

Other inclusion applies.

Exclusion Criteria:

  • Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
  • Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
  • Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.

Other exclusion applies.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243295

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00243295     History of Changes
Other Study ID Numbers: 3100N7-110
Study First Received: October 19, 2005
Last Updated: October 5, 2006
Health Authority: France: Ministry of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
osteoarthritis
deformity of knee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014