Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000403
Status:
COMPLETED
Last Update Posted:
2013-04-30
First Post:
1999-11-03
Brief Title:
Doxycycline and OA Progression
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Effect of Doxycycline on Osteoarthritis OA Progression
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 N216group 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-027 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR043348 |
| R01AR043348 | NIH | None | None |