Osteoarthritis Initiative (OAI): A Knee Health Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
GlaxoSmithKline
Merck Sharp & Dohme Corp.
Novartis
Pfizer
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00080171
First received: March 24, 2004
Last updated: March 31, 2009
Last verified: March 2009
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Osteoarthritis Initiative (OAI): A Knee Health Study

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Biospecimen Retention:   Samples With DNA

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)
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.

  Eligibility

Ages Eligible for Study:   45 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080171

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

Additional Information:
No publications provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gayle Lester, PhD, NIAMS
ClinicalTrials.gov Identifier: NCT00080171     History of Changes
Other Study ID Numbers: NIAMS-109
Study First Received: March 24, 2004
Last Updated: March 31, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Osteoarthritis
Knee Pain
Knee Health

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014