A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography
In order to design future disease modifying osteoarthritis drug (DMOAD) proof of concept studies, this study is being conducted to assess magnetic resonance imaging (MRI) measurements of cartilage morphology and glycosaminoglycan (GAG) content as it relates to the progression of disease in subjects with potentially rapidly progressing OA. The subject population is selected to have higher likelihood of having rapidly progressing OA (i.e., a more rapid joint space narrowing (JSN) compared to general knee OA population and thus, may be more likely to have changes in GAG content and/or cartilage volume. The results of this study may provide a reasonable means to assess DMOAD activity of drugs in development. The non-OA controls are included to determine the rate of change for subjects of similar age. Ideally, results of this study will identify reliable methods for delayed Gadolinium Enhanced MRI of cartilage (dGEMRIC) and MRI cartilage assessment that correlate with OA disease progression as compared to x-ray changes.
|Study Design:||Observational Model: Case Control
Time Perspective: Longitudinal
|Official Title:||A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography|
|Study Start Date:||August 2004|
|Study Completion Date:||July 2007|
Subjects with potentiall rapidl progressing OA
Age-matched healthy subjects with no knee pain
The objective of the study are:
- Evaluate OA progression by evaluating cartilage morphology, cartilage glycosaminoglycan (GAG) content, and joint space changes measured by MRI (3.0T), dGEMRIC index, and radiography, respectively using age-matched control subjects to identify disease related changes.
- Identify subject characteristics associated with more rapidly progressing OA.
- Identify most sensitive efficacy endpoints for future DMOAD proof of concept (POC) studies.
- Establish time interval for future studies based on MRI endpoints.
- Evaluate the effect of contrast agent on MRI cartilage morphology and T2 measurements
- Define criteria for classifying cartilage legions/deficits using dGEMRIC and T2 measurements.
- Collect biofluid samples for future validation of disease specific biomarkers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505297
|United States, California|
|University of California - San Frnacisco|
|San Francisco, California, United States, 94107|
|Principal Investigator:||Sharmila Majumdar, PhD||University of California, San Francisco|
|Principal Investigator:||Thomas M. Link, M.D.||University of California, San Francisco|