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Osteoarthritis Initiative (OAI): A Knee Health Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00080171
Recruitment Status : Completed
First Posted : March 25, 2004
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
GlaxoSmithKline
Merck Sharp & Dohme LLC
Novartis
Pfizer
Information provided by (Responsible Party):
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Description
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Brief Summary:
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 or disease
Osteoarthritis Knee Osteoarthritis

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 4796 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Osteoarthritis Initiative (OAI): A Knee Health Study
Study Start Date : February 2004
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
Blood, urine

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who have knee OA or are at high risk for developing knee OA
Criteria

Inclusion Criteria:

Must meet one of the following criteria:

  • Overweight
  • Previous knee injury or surgery
  • Knee pain during the past year. Participants do not need to have current knee pain to take part in the study.
  • Parent or sibling who had knee replacement

Exclusion Criteria:

  • Rheumatoid arthritis
  • Joint replacements in both knees
  • Unable to walk without assistance
  • Unable to undergo MRI of the knee
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080171


Locations
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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
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
GlaxoSmithKline
Merck Sharp & Dohme LLC
Novartis
Pfizer
Investigators
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Study Director: Gayle Lester, PhD National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00080171    
Other Study ID Numbers: NIAMS-109
First Posted: March 25, 2004    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: March 2009
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Osteoarthritis
Knee Pain
Knee Health
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases