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| Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) GlaxoSmithKline Merck Novartis Pfizer |
|---|---|
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00080171 |
Purpose
Knee osteoarthritis (OA) is the most common cause of disability in adults. The "Osteoarthritis Initiative (OAI): A Knee Health Study" is a nationwide research study that will help researchers gather more information about the physical changes that occur prior to the onset of arthritis symptoms or before OA gets worse. The purpose of this study is to examine people who have knee OA or are at high risk for knee OA; information will be used to better understand how to prevent and treat knee OA.
| Condition |
|---|
|
Osteoarthritis Knee Osteoarthritis |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Osteoarthritis Initiative (OAI): A Knee Health Study |
Blood, urine
| Estimated Enrollment: | 5000 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
Knee OA causes more health problems and medical expenses that any other form of arthritis. Symptoms of OA can range from stiffness and mild pain to severe joint pain and even disability. Previous research has shown that certain factors, such as knee pain, prior knee injury or knee surgery, OA of the hand, or obesity, may lead to knee OA. The OAI is a multicenter, observational study of knee OA that will collect information on potential biomarkers for OA and trends in OA onset and progression.
The OAI will recruit and follow participants who have knee OA or are at high risk for developing knee OA for an eight-year period at one of four clinical centers. Blood and urine collection, magnetic resonance imaging (MRI), and X-rays will be completed at each of four annual follow-up visits. A questionnaire and physical examination at screening will assess for risk factors for the development and progression of knee OA. Levels of knee pain and physical disability will be assessed at study start and at each of the follow-up visits by questionnaire and examination.
Eligibility| Ages Eligible for Study: | 45 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Participants who have knee OA or are at high risk for developing knee OA
Inclusion Criteria:
Must meet one of the following criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Memorial Hospital of Rhode Island / Brown University | |
| Pawtucket, Rhode Island, United States, 02860 | |
| Study Director: | Gayle Lester, PhD | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
More Information
| Responsible Party: | NIAMS ( Gayle Lester, PhD ) |
| Study ID Numbers: | NIAMS-109 |
| Study First Received: | March 24, 2004 |
| Last Updated: | March 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00080171 History of Changes |
| Health Authority: | United States: Federal Government |
|
Osteoarthritis Knee Pain Knee Health |
|
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases |
|
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
