OsteoarthritisPhase 3NCT00000403
Doxycycline and OA Progression
A Phase 3 study testing Doxycycline in people with Osteoarthritis, run by Indiana University at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 64 years, women only
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Doxycycline
- How many people
- 432 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 1996to Jul 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Northwestern University Medical Center
Chicago, Illinois, 60611
Indiana University Medical Center
Indianapolis, Indiana, 46202-5100
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213-3221
University of Arizona Arthritis Center
Tucson, Arizona, 85724
Arthritis Research Center Foundation
Wichita, Kansas, 67214
About this study
Official title: Effect of Doxycycline on Osteoarthritis (OA) Progression
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Doxycycline
- Keywords
- Osteoarthritis (OA), Knee, Doxycycline, Skeletal disorder, Placebo, Urinalysis, NSAIDs, Joint space narrowing (JSN), WOMAC
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startSep 1996
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 432 participants
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kenneth D. Brandt, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000403
- Sponsor's protocol ID
- R01AR043348
- Other IDs
- R01AR043348, NIAMS-027
- Status last verified
- Apr 2013
- First submitted
- 3 Nov 1999
- Last updated
- 30 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Doxycycline on Osteoarthritis (OA) Progression
- ClinicalTrials.gov ID
- NCT00000403
- Acronym / sponsor ID
- R01AR043348
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis (OA), Knee, Doxycycline, Skeletal disorder, Placebo, Urinalysis, NSAIDs, Joint space narrowing (JSN)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA)
- Study start
- Sep 1996
- Study completion
- Jul 2001
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxycycline | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth D. Brandt, M.D. principal investigator
Indiana University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxycycline in people with Osteoarthritis, run by Indiana University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.