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Trial record 1 of 1 for:    NCT00080171
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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 Corp.
Novartis
Pfizer
Information provided by (Responsible Party):
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Tracking Information
First Submitted Date March 24, 2004
First Posted Date March 25, 2004
Last Update Posted Date September 29, 2020
Study Start Date February 2004
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Osteoarthritis Initiative (OAI): A Knee Health Study
Official Title Osteoarthritis Initiative (OAI): A Knee Health Study
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, urine
Sampling Method Non-Probability Sample
Study Population Participants who have knee OA or are at high risk for developing knee OA
Condition
  • Osteoarthritis
  • Knee Osteoarthritis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 25, 2020)
4796
Original Enrollment
 (submitted: June 23, 2005)
5000
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00080171
Other Study ID Numbers NIAMS-109
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study Sponsor National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators
  • GlaxoSmithKline
  • Merck Sharp & Dohme Corp.
  • Novartis
  • Pfizer
Investigators
Study Director: Gayle Lester, PhD National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
PRS Account National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Verification Date March 2009