NCT00000403

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 1996

Longer than P75 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1996

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

First QC Date

November 3, 1999

Last Update Submit

April 29, 2013

Conditions

Osteoarthritis

Keywords

Osteoarthritis (OA)KneeDoxycyclineSkeletal disorderPlaceboUrinalysisNSAIDsJoint space narrowing (JSN)WOMAC

Interventions

DoxycyclineDRUG

Eligibility Criteria

Age45 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Arizona Arthritis Center

Tucson, Arizona, 85724, United States

Location

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202-5100, United States

Location

Arthritis Research Center Foundation

Wichita, Kansas, 67214, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-3221, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Kenneth D. Brandt, M.D.

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

September 1, 1996

Study Completion

July 1, 2001

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

US(6)