Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00243295

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 I

MedlinePlus related topics: Osteoarthritis

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
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

Further study details as provided by Wyeth:

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

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

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

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

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

Keywords provided by Wyeth:

osteoarthritis
deformity of knee

Study placed in the following topic categories:

Calcium, Dietary
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Rheumatic Diseases
Congenital Abnormalities

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009