The Osteoarthritis Initiative (OAI), a public-private partnership between the National Institutes of Health (NIH) and private industry that seeks to improve diagnosis and monitoring of osteoarthritis (OA) and foster development of new treatments, has released its first set of data.
Making this information available to researchers worldwide will expedite the pace of scientific studies and identification of biological and structural markers (biomarkers) for OA. Researchers can analyze the data to form new hypotheses for further study of OA, which is the major cause of activity limitation and disability in older people. Images, including x rays and magnetic resonance imaging scans, will also be available to researchers upon request. All data are stored with an anonymous identification number to protect the confidentiality of the participants' information.
"Since its inception, the OAI has been a premier example of how industry, government, and academic sectors might work together to add value to biomedical research," says NIH Director Elias A. Zerhouni, M.D. "This first data release is proof positive that with cooperation, we can achieve results that neither the government nor its private partners is able to reach alone."
Over the next five years, the OAI will provide an unparalleled, state-of-the-art longitudinal database of images and clinical outcome information to facilitate the discovery of biomarkers for development and progression of OA. In this case, a biomarker would be a physical sign or biological substance that indicates changes in bone or cartilage.
Nearly 5,000 people at risk of developing knee OA, in the early stage of the disease or with more advanced knee OA are participating in the OAI at four centres around the United States. Participants in the research study provide biological specimens (blood, urine, and DNA); images (X rays and magnetic resonance scans); and clinical data such as dietaryintake, medication use and pain, function, and general health assessments.
Data gathered from participants are available to researchers at http://www.oai.ucsf.edu. The data include symptoms; pain severity; a measure of pain, stiffness, and function known as the WOMAC OA index; walking ability; endurance; balance and strength; nutrition; and prescription medicines and alternative therapies used by the participants.
A second set of data will be released later in 2006, and a third release will take place early in 2007. Subsequent data will be released at approximately six-month intervals.
The four centres taking part in the study and their principal investigators include: The University of Maryland School of Medicine, Baltimore; Marc Hochberg, M.D., M.P.H., in conjunction with Johns Hopkins Bayview
Medical Center; Joan Bathon, M.D; The Ohio State University, Columbus; Rebecca Jackson, M.D.; The University of Pittsburgh; C. Kent Kwoh, M.D.; Memorial Hospital of Rhode Island , Pawtucket; Charles Eaton, M.D.
The study is coordinated and the data from the study and the Web site are managed by the University of California, San Francisco. The principal investigator for the Data Coordinating Center is Michael Nevitt, Ph.D.
Today, 35 million people -- 13 per cent of the U.S. population -- are 65 and older, and more than half of them have radiological evidence of osteoarthritis in at least one joint. By 2030, an estimated 20 per cent of Americans -- about 70 million people - will have passed their 65th birthday and will be at increased risk for OA.
The OAI is a public-private partnership comprised of five contracts funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA), Office of Research on Women's Health (ORWH), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Center on Minority Health and Health Disparities (NCMHD) and National Center for Complementary and Alternative Medicine (NCCAM), all part of the Department of Health and Human Services' National Institutes of Health. Private funding partners include Merck Research Laboratories, Novartis Pharmaceuticals Corporation, GlaxoSmithKline, and Pfizer Inc. Private-sector funding for the OAI is managed by the Foundation for the National Institutes of Health.
The mission of the NIAMS is to support research into the causes, treatment and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases.