A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography
NCT00505297
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- Female patients evaluated to be relatively in good health
- 40 years old and above
- Negative pregnancy test
Additional inclusion criteria for OA patients:
- Frequent knee symptoms in the past year, defined as:
- pain, aching, or stiffness on most days of a month during the past year
- use od medication (all types) for treatment of knee pain on most days of a month during the past year
- Kellgren & Lawrence Grades 2 or 3 of the study knee (with either the same or less severe OA , or no OA in the contralateral knee)
- Body mass index (BMI) of 30 and above
- Medial joint space width of 2 mm and above
Additional inclusion criteria for age-matched controls:
- BMI of 28 and above
- No evidence of knee OA in either knee (i.e., Kellgren & Lawrence Grade 0 diagnosed by x-ray on AP view; infrequent knee pain, aching, stiffness during the past year; infrequent use of medication (all types) for treatment of knee pain during the past year.
- Anticipated need for knee surgery in the next 2 years
- OA predominantly in the lateral tibiofemoral compartment measured by PA x-ray view of
the study knee
- Intra-articular steroids to study joint (3 month washout), intra-articular hyaluronic
acid to the study joint (3 month-washout), doxycycline (3 month washout), or
arthroscopy within the last 6 months
- Medial joint space width less than 2 mm measured by PA view of knee x-ray
- History of joint replacement, intra-articular fracture, osteotomy, arthroplasty, or
meniscectomy of the study knee
- History of other diseases that may involve the study joint including inflammatory
joint diseases, crystalline disease, endocrinopathies, metabolic, diseases, knee
infection of the study knee, neuropathic disorders, avascular necrosis, Paget's
disease, or tumors (chondrocalcinosis is acceptable; treated thyroid disease is
acceptable)
- Systemic inflammatory diseases (e.g., Rheumatoid arthritis)
- Other pain that the principal investigator feels can not be distinguished from knee
pain (e.g., lumbar pain, hip pain, trochanteric bursitis)
- Musculoskeletal pain that may preclude the subject from remaining motionless for the
MRI acquisitions
- Unable to undergo an MRI exam of the knee because of contraindications
- Unable to receive gadopentate contrast agent injection because of contraindications. A
study subject who displays any sign of an allergic reaction to the contrast agent will
be withdrawn from the dGEMRIC part of the protocol and will not receive any subsequent
contrast agent injection. The subject may continue to complete the remainder fo the
study, which includes MR morphometry scan, collection of blood and urine sample for
biomarker assays, and completion of study questionnaires.
- Clinical chemistry laboratory values more than 2 times the upper limit of normal
- Participation in clinical trial with a study during in the past 14 days
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or may
interfere with the interpretation of trial results and, in the judgment of the
investigator, would make the subject inappropriate for entry in the this trial
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Descriptive Information | |||||||
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Brief Title | A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography | ||||||
Official Title | A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography | ||||||
Brief Summary | 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. | ||||||
Detailed Description | The objective of the study are:
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Study Type | Observational | ||||||
Study Design | Observational Model: Case-Control Time Perspective: Other | ||||||
Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Not Provided | ||||||
Study Population | Not Provided | ||||||
Condition | Osteoarthritis | ||||||
Intervention | Not Provided | ||||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment | 18 | ||||||
Original Actual Enrollment | Same as current | ||||||
Actual Study Completion Date | July 2007 | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria | Inclusion Criteria:
Additional inclusion criteria for OA patients:
Additional inclusion criteria for age-matched controls:
Exclusion Criteria:
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Sex/Gender |
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Ages | 40 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT00505297 | ||||||
Other Study ID Numbers | A9001140 H6513-25393 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor | University of California, San Francisco | ||||||
Collaborators | Pfizer | ||||||
Investigators |
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PRS Account | University of California, San Francisco | ||||||
Verification Date | October 2006 |