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Completed

NCT Number: NCT00243295

Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rhBMP-2/CPM

Drug

Primary outcomes

  1. Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies

  2. Feasibility measures include

  3. Injection of desired volume of rhBMP-2/CPM within the osteotomy defect

  4. Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Oct 21, 2005
Registry last updated
Oct 6, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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