A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography

NCT00505297

Last updated date
Study Location
University of California - San Frnacisco
San Francisco, California, 94107, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Pfizer Clinical Trials Contact Center

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[email protected]

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