This proposal is a second submission requesting support for the investigators in the Clinical Centers in the Study of Osteoporotic Fractures (SOF) to analyze data, publish results, and continue scientific participation in SOF during the 4th and 5th years of our competitively renewed and (partially) funded 5-year study. We are NOT requesting support for collecting data or assaying samples and we have NOT changed any aspect of the funded 5-year study. SOF was renewed in August 2006 to study why some women achieve excellent lower extremity and cognitive function in the 9th and 10th decades of life and why some women have maintained healthy trajectories of lower extremity and cognitive function over 10 years of follow-up. We are specifically testing whether renal function, inflammation, and vitamin D are important to maintaining and achieving high levels of function and lower risks of falls, and hip fractures. Each SOF Clinical Center PI took the lead in developing one of the SOF Aims. NIH funded our Year 20 Exam in which we measured cognitive and lower extremity function. We completed the visits at the end of September, 2008 and will select and pull samples in November 2008 in order to begin biomarker assays by the end of the year. The bulk of the data will be analyzed and papers produced in the 4th and 5th years of the renewal. Investigators at the Clinical Centers - including young investigators - would do most of that work. The Coordinating Center was funded for 5 years. However, Clinical Centers were funded for only 3 years (8/1/06-7/31/09) just to complete the Exam. The 3-year limit on Clinical Center funding would - inadvertently - prevent the Clinical Center investigators from analyzing and publishing results from the aims they developed. Therefore, we request support for the SOF Clinical Center investigators to analyze and publish results from this funded competitive renewal during the 4th and 5th years of our renewal and continue their essential participation in the scientific activities of SOF. In addition, NIA requested that we include a plan for public data sharing for SOF in this proposal. Our plan builds on our successful public access web portal, SOF Online, and proposes to add downloadable and documented public release data sets to the website to allow external investigators direct access to de-identified SOF data. In our revised proposal, we address issues raised by the reviewers regarding innovation, dual trajectory studies, selection and scoring of cognitive tests and data sharing plan.
The Study of Osteoporotic Fractures (SOF) was competitively renewed to study why some women achieve and maintain high cognitive and physical function, and low risk of falls and fractures in the 9th and 10th decade of life. The SOF Coordinating Center was funded for 5 years;SOF clinical centers for 3 years. In order to meet these aims, two years of support is requested for the SOF clinical centers.
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