Osteoarthritis Initiative

Principal Investigators:

     Kevin Hackshaw, MD
     Ronald L. Whisler, MD
     Rebecca D. Jackson, MD

The Ohio State University Department of Internal Medicine is one of four U.S. clinical sites chosen to conduct the Osteoarthritis Initiative (OAI), a public-private partnership aimed at finding biological and structural markers (biomarkers) for the development and progression of this joint disease.

The seven-year project will recruit 5,000 men and women aged 50 and above at high risk for developing symptomatic knee osteoarthritis. Investigators expect the initiative to help speed OA drug development, which is impeded by the lack of objective and measurable standards for disease progression needed for drug evaluation.

Research in this arena is critical, considering that as the number of graying baby boomers in the United State continues to grow, many 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.

The OAI centers will 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.

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.

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 Foundation for the National Institutes of Health is facilitating the consortium. Other OAI public partners 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.

For more information on the OAI, visit http://www.niams.nih.gov/ne/oi/index.htm.

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