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Sponsors and Collaborators: |
University of California, San Francisco Pfizer |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00505297 |
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.
Condition |
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Osteoarthritis |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Case Control, Retrospective/Prospective Study |
Official Title: | A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography |
Enrollment: | 18 |
Study Start Date: | August 2004 |
Study Completion Date: | July 2007 |
Groups/Cohorts |
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A: Case
Subjects with potentiall rapidl progressing OA
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B: Control
Age-matched healthy subjects with no knee pain
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The objective of the study are:
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Additional inclusion criteria for OA patients:
Additional inclusion criteria for age-matched controls:
Exclusion Criteria:
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 |
Study ID Numbers: | A9001140, H6513-25393 |
Study First Received: | July 20, 2007 |
Last Updated: | July 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00505297 History of Changes |
Health Authority: | United States: Institutional Review Board |
Osteoarthritis (OA) Magnetic Resonance Imaging (MRI) delayed Gadolinium Enhanced MRI of cartilage (dGEMRIC) |
disease modifying osteoarthritis drug (DMOAD) Potentially rapidly progressing osteoarthritis MRI measurement of cartilage |
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Disease Progression Rheumatic Diseases |
Disease Attributes Pathologic Processes Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Disease Progression Rheumatic Diseases |