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Doxycycline and OA Progression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000403
First Posted: November 4, 1999
Last Update Posted: April 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Indiana University
  Purpose

This study will determine whether doxycycline decreases the severity or rate of progression of osteoarthritis (OA) in the knee. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most popular agents used to treat OA, but elderly women, in whom OA is especially common, are at greatest risk of developing serious side effects from NSAIDs.

Our study targets overweight middle-aged women who have OA in one knee. Half of the 432 study participants will receive the treatment (doxycycline) and half will receive a placebo (inactive pill). Treatment with doxycycline (or placebo) will last 30 months, and participants and researchers will not know who is receiving doxycycline and who is receiving placebo until the end of the study. We will look for narrowing of the joint space in the knee that was not affected by OA at the start of the study. Joint space narrowing is a sign of OA. We will also use questionnaires to evaluate participants' symptoms and functioning.


Condition Intervention Phase
Osteoarthritis Drug: Doxycycline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Doxycycline on Osteoarthritis (OA) Progression

Resource links provided by NLM:


Further study details as provided by Indiana University:

Estimated Enrollment: 432
Study Start Date: September 1996
Estimated Study Completion Date: July 2001
Detailed 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 treatment or placebo groups (N=216/group). Participants will receive either doxycycline (treatment) or placebo for 30 months.

We will use several strategies to maximize compliance with the study medications and retention of participants in the study, including a "faintness-of-heart" test, which will be used at the outset to eliminate people unlikely to comply, and use of a computerized medicine cap to provide information on compliance with the prescribed dosing regimen between visits. These strategies will permit study personnel to aim their efforts to enhance compliance at those participants who can best benefit from these efforts.

The primary outcome variable is minimum joint space width (or joint space narrowing, JSN) in the medial tibiofemoral compartment of the knee that is normal at baseline. In addition, we will examine changes in an algofunctional index (WOMAC), global arthritis activity, general health status (SF-36), and use of health services in the two treatment groups.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000403


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
University of Arizona Arthritis Center
Tucson, Arizona, United States, 85724
United States, Illinois
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202-5100
United States, Kansas
Arthritis Research Center Foundation
Wichita, Kansas, United States, 67214
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-3221
Sponsors and Collaborators
Indiana University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Aging (NIA)
Investigators
Principal Investigator: Kenneth D. Brandt, M.D. Indiana University School of Medicine
  More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00000403     History of Changes
Other Study ID Numbers: R01AR043348 ( U.S. NIH Grant/Contract )
NIAMS-027
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: April 30, 2013
Last Verified: April 2013

Keywords provided by Indiana University:
Osteoarthritis (OA)
Knee
Doxycycline
Skeletal disorder
Placebo
Urinalysis
NSAIDs
Joint space narrowing (JSN)
WOMAC

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents