Clinical research in OA--the NIH Osteoarthritis Initiative.

tify and characterize the disease from onset to joint replacement. There are currently data and images available for the baseline, 12and 24-month visits of the cohort. Data from the 36-month visit will be available in the coming year. The cohort is 58% female with 21% minority enrollment. There are three sub-groups: progression (29%), incidence (68%), and non-exposed (3%). The ages ranged from 45-79 at baseline and the distribution of ages ranges from 12% in the youngest to 23% in the oldest with 30% in the middle years. Biospecimens (blood and urine) are obtained at every visit and DNA has been extracted from all the baseline specimens. These specimens are available by application. The OAI clinics began the fourth and final year (in the existing contract) of follow-up visits for the cohort in 2008. The NIH and other consortium members have determined that widespread availability of validated biomarkers and other research tools arising from use of the OAI resource by third parties is necessary to maximize the public health benefit of the Initiative. Thus, renewable resources from the OAI, such as clinical data and X-ray information, are made freely available to qualified scientists everywhere. These clinical and imaging data have been released to the OAI public web site (http://www.oai.ucsf.edu) at regular intervals since June 2006. Currently there are over 850 registered users of this public web site in 47 countries. Over 1,500 clinical data sets have been downloaded and 87 image data sets have been distributed to national and international users. For OAI resources that are limited, such as the biospecimens, priority will be given to the validation of biomarkers that, in addition to demonstrating scientific merit, will be made widely available for use in accordance with the NIH Principles and Guidelines on Obtaining and Disseminating Biomedical Research Resources. The OAI relies on the following clinical 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 J Musculoskelet Neuronal Interact 2008; 8(4):313-314