Search / Trial NCT00000403

Doxycycline and OA Progression

Launched by INDIANA UNIVERSITY · Nov 3, 1999

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Osteoarthritis (Oa) Knee Doxycycline Skeletal Disorder Placebo Urinalysis Nsai Ds Joint Space Narrowing (Jsn) Womac

Description

This study is a double-blind, multicenter randomized controlled trial of doxycycline on osteoarthritis (OA) progression. Our previous research suggests that doxycycline might help prevent or slow OA development by reducing breakdown of cartilage in joints. The target population is one that is at high risk for the development of bilateral knee OA: overweight middle-aged women with unilateral knee OA at baseline. We hypothesize that doxycycline will decrease the severity or rate of progression of OA. We are recruiting 432 study participants across six clinical centers and randomizing them to ...

Gender

Female

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.

Attachments

readout_NCT00000403_2024-03-02.pdf

4.5 MB

NCT00000403_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Indianapolis, Indiana, United States

Birmingham, Alabama, United States

Tucson, Arizona, United States

Chicago, Illinois, United States

Wichita, Kansas, United States

Pittsburgh, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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