Study Overview and Objectives

The Osteoarthritis Initiative (OAI) is a multi-center, longitudinal, prospective observational study of knee osteoarthritis (OA). The overall aim of the OAI is to develop a public domain research resource to facilitate the scientific evaluation of biomarkers for osteoarthritis as potential surrogate endpoints for disease onset and progression.

Osteoarthritis (OA) is the most common form of arthritis and the major cause of activity limitation and physical disability in older people. Today, 35 million people (13 percent 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, 20 percent of Americans (about 70 million people) will have passed their 65th birthday and will be at risk for OA.

At present, therapies available to treat osteoarthritis are limited. Most current treatments are designed only to relieve pain and reduce or prevent the disability caused by bone and cartilage degeneration. Drug therapies target the symptoms but not the cause of this disease; no treatment inhibits the degenerative structural changes that are responsible for its progression. Furthermore, clinical testing of new therapies is complicated by highly variable way that OA is manifested in individual patients.

Four clinical centers and a data coordinating center will conduct the Osteoarthritis Initiative (OAI), a public-private partnership that will bring together new resources and commitment to help find biochemical, genetic and imaging biomarkers for development and progression of OA. The OAI will establish and maintain a natural history database for osteoarthritis that will include clinical evaluation data, radiological (x-ray and magnetic resonance) images, and a biospecimen repository from 4796 men and women ages 45-79 enrolled between February 2004 and May 2006. Four 3.0 Tesla MRI scanners, one at each clinical center, are dedicated to imaging the knees of OAI participants annually over four years. The seven-year project will recruit participants who have, and those who are at high risk for developing, symptomatic knee osteoarthritis. All data and images collected will be available to researchers worldwide to help quicken the pace of biomarker identification, scientific investigation and OA drug development. Access to biospecimens will be by application to the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS).

The OAI consortium includes public funding from the National Institutes of Health (NIH) and private funding from several pharmaceutical company partners managed by the Foundation for the National Institutes of Health.

When complete, the OAI should provide an unparalleled state-of-the-art database showing both the natural progression of the disease and information on imaging and biochemical biomarkers and outcome measures.

See the Study design protocol (0.65 mb) Acrobat Icon and Appendices (2.5 mb) Acrobat Icon for a comprehensive description of the study plan.

See funding for a complete list of the public and private sponsors and collaboration worldwide for a complete list of collaborators.