Four clinical centers and a data coordinating center have been selected to conduct the Osteoarthritis Initiative (OAI), the public-private partnership that will bring together new resources and commitment to help find biological and structural markers (biomarkers) for development and progression of this joint disease. Osteoarthritis is the most common form of arthritis and the major cause of activity limitation and physical disability in older people.
The seven-year project will recruit 5,000 men and women aged 50 and above at high risk for developing symptomatic knee osteoarthritis. The OAI will rely on the following centers and their principal investigators:
University of Maryland School of Medicine, Baltimore; Marc Hochberg, M.D., M.P.H.
The Ohio State University, Columbus; Rebecca Jackson, M.D.
University of Pittsburgh; C. Kent Kwoh, M.D.
Memorial Hospital of Rhode Island, Pawtucket; Annlouise Assaf, Ph.D., F.A.H.A.
University of California, San Francisco (data coordinating center); Michael Nevitt, Ph.D.
The initiative should help speed OA drug development, which is hindered by the lack of objective and measurable standards for disease progression needed for drug evaluation.
The OAI consortium includes public funding from the National Institutes of Health (NIH) and private funding from several pharmaceutical companies: GlaxoSmithKline, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, and Pfizer. The consortium is being facilitated by the Foundation for the National Institutes of Health. The OAI will allow the centers to establish and maintain a natural history database for osteoarthritis that will include clinical evaluation data and radiological (x-ray and magnetic resonance) images, and a biospecimen repository. All data and images collected will be available to researchers worldwide to help quicken the pace of scientific studies and biomarker identification.
“Our challenge is to establish a carefully collected information archive that will drive development in OA biomarkers. With government and the private sector working together, we can accomplish what neither could do alone-and we’re now poised to begin,” said Dr. Stephen I. Katz, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), one of the principal OAI sponsors.
According to Dr. Richard J. Hodes, director of the National Institute on Aging (NIA), “The OAI study is a critical research resource that can enhance our ability to help large numbers of older women and men with osteoarthritis. I expect that the OAI Centers will provide the building blocks of data to accelerate progress in osteoarthritis research.” The NIA is the other principal federal sponsor of the OAI.
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 the fact that the disease manifests itself differently in each person.
When complete, the OAI should provide an unparalleled state-of-the-art database showing both the natural progression of the disease and information on biomarkers, x rays and outcome measures. This database should allow investigators to identify potential new disease targets and develop tools for understanding how to measure clinically meaningful improvements.
As the U.S. population swells with graying baby boomers, vast numbers of people will suffer from osteoarthritis. 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.
In addition to the NIA and NIAMS, other public partners in the Osteoarthritis Initiative at NIH include the Office of Research on Women’s Health, National Institute of Dental and Craniofacial Research, National Center on Minority Health and Health Disparities, and the National Center for Complementary and Alternative Medicine. The National Center for Research Resources, the Office of Technology Transfer, the Office of the General Counsel, and the Office of Science Policy have also played pivotal roles in the establishment of this initiative. Another Department of Health and Human Services component involved is the Center for Drug Evaluation and Research of the Food and Drug Administration. Private-sector funding for the OAI is being managed by the Foundation for the National Institutes of Health.