Clinical trial: A Longitudinal Study of Osteoarthritis (OA) Disease Progression Measured by MRI, dGEMRIC, and Radiography (NCT00505297)

Eligibility criteria:
Inclusion Criteria:

          -  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:

          -  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
Female
Accepts Healthy Volunteers
Subject must be at least 40 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment