Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000425
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
1999-11-03
Brief Title:
Toward Better Outcomes in Osteoarthritis
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Toward Better Outcomes in Osteoarthritis OA Finding the Appropriate Role for Nonsteroidal Anti-inflammatory Drugs NSAIDs
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine if there is a difference between commonly used nonsteroidal anti-inflammatory drugs NSAIDs and acetaminophen a pain-reliever that does not prevent inflammation for treating knee pain in osteoarthritis OA The two main results we will look at are disease progression according to x-rays and disability over 35 years Study participants with moderate knee OA and knee pain will continue taking their NSAID or stop taking their NSAID and start taking acetaminophen Every 6 months we will send the participants questionnaires that ask about pain medication use and disability We will take x-rays of the knees at the start of the study and again at the end of the study
Detailed Description:
Nonsteroidal anti-inflammatory drugs NSAIDs are the most popular agents used to treat the joint pain and inflammation associated with OA Although NSAIDs are useful for pain management recent studies have not found NSAIDs to be better than acetaminophen for the treatment of painful knee OA The relative lack of efficacy and possibility of accelerated disease progression coupled with the known gastrointestinal risks of these medications especially to the elderly have led us to reevaluate NSAIDs as the first-line medical therapy for osteoarthritis Our dominant NSAID-based approach to this disease may be resulting in unnecessary costs unnecessary toxicity and accelerated disability
These data allow us to hypothesize that NSAIDs by inhibiting pain and inflammation in osteoarthritic joints may cause or encourage people with OA to overuse damaged joints resulting in accelerated joint degeneration and joint replacements at an earlier time or alternatively that treatment with NSAIDs may accelerate joint damage by altering cartilage metabolism and inhibiting joint healing We further hypothesize that anti-inflammatory therapy with NSAIDs results in toxicities that lead to increased comorbidity and higher medical care use compared to analgesic therapy for OA
The specific aims of our study are to determine if 1 nonsteroidal anti-inflammatory drug therapy accelerates joint degeneration compared to analgesic medications and 2 nonsteroidal anti-inflammatory drug therapy results in greater comorbidity and higher medical care costs and use compared to simple analgesic medication To accomplish these aims we will randomize 200 people with knee OA and 200 people with hip OA defined by a Kellgren and Lawrence x-ray grade of 2 or 3 currently on NSAIDs to either NSAIDs at their current dose or acetaminophen up to 4000 mgday for 4 years
Primary outcome measures will be the rate of radiographic progression and pain and disability in the two groups Secondary outcome variables will include medical care use time to joint replacements and medication side-effect profiles We will separately identify and describe those clinical demographic and radiographic variables that predict accelerated progression in each group by multivariate analyses By these methods we will determine the long-term outcome of NSAID therapy versus analgesic therapy for the treatment of clinical OA of the knee and hip This information is critical to improving the outcome of a disease that is the principal cause of disability in the elderly
These data allow us to hypothesize that NSAIDs by inhibiting pain and inflammation in osteoarthritic joints may cause or encourage people with OA to overuse damaged joints resulting in accelerated joint degeneration and joint replacements at an earlier time or alternatively that treatment with NSAIDs may accelerate joint damage by altering cartilage metabolism and inhibiting joint healing We further hypothesize that anti-inflammatory therapy with NSAIDs results in toxicities that lead to increased comorbidity and higher medical care use compared to analgesic therapy for OA
The specific aims of our study are to determine if 1 nonsteroidal anti-inflammatory drug therapy accelerates joint degeneration compared to analgesic medications and 2 nonsteroidal anti-inflammatory drug therapy results in greater comorbidity and higher medical care costs and use compared to simple analgesic medication To accomplish these aims we will randomize 200 people with knee OA and 200 people with hip OA defined by a Kellgren and Lawrence x-ray grade of 2 or 3 currently on NSAIDs to either NSAIDs at their current dose or acetaminophen up to 4000 mgday for 4 years
Primary outcome measures will be the rate of radiographic progression and pain and disability in the two groups Secondary outcome variables will include medical care use time to joint replacements and medication side-effect profiles We will separately identify and describe those clinical demographic and radiographic variables that predict accelerated progression in each group by multivariate analyses By these methods we will determine the long-term outcome of NSAID therapy versus analgesic therapy for the treatment of clinical OA of the knee and hip This information is critical to improving the outcome of a disease that is the principal cause of disability in the elderly
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 |
|---|---|---|---|
| P01AR043584 | NIH | None | None |
| NIAMS-033 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01AR043584 |