Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00000403
Eligibility Criteria:
Inclusion Criteria:
* Women 45-64 years of age.
* Upper tertile of sex-, age- and race-adjusted norms for body mass index.
* Unilateral knee OA at baseline.
* Postmenopausal status or otherwise incapable of childbearing.
* Ability to ambulate (move about) independently without assistive devices.
* Ability to read and write in English or Spanish and give informed consent.
Exclusion Criteria:
* Premenopausal status (unless subject has had a hysterectomy).
* Current use of any investigational drug.
* Significant hematologic, renal, hepatic or cardiovascular disease (but not including mild/moderate hypertension) or any other serious medical condition that might preclude the subject's ability to participate fully in the project, keep clinic appointments, etc.
* Prior surgery (including arthroscopy) of the contralateral knee.
* Significantly abnormal laboratory values at the time of enrollment.
* Pigmented villonodular synovitis of the knee.
* Synovial chondromatosis.
* Charcot arthropathy.
* A known "secondary" cause of OA, including acute or chronic infectious OA; crystal-induced arthritis; systemic inflammatory connective tissue disease (e.g., rheumatoid arthritis, systemic lupus erythematosus); osteonecrosis; Paget's disease; or metabolic diseases, such as hemochromatosis, Wilson's disease, or ochronosis. Chondrocalcinosis, however, will not be an exclusion criterion.
* Conditions other than knee OA which limit lower extremity function and mobility and/or would confound the evaluation of knee pain and function (e.g., clinically significant spinal or hip arthritis, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, stroke, etc.).
* Steroid injection into either knee within past 3 months.
* A history of photosensitivity (sensitivity to light) or any other adverse reaction to a tetracycline.
* Failure to pass a "faintness-of-heart" test (pre-randomization compliance test).
* Prior chronic use of tetracycline (e.g., for severe acne).
* Severe OA (Kellgren and Lawrence Grade IV) of the index knee.
* Salicylate use, with a mean dose \>2g/d.
* Institutionalization.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
64 Years
Study:
NCT00000403
Study Brief:
Protocol Section:
NCT00000403