National Institutes of Health, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Natcher Building, Room 5AS-13A, 45 Center Drive, MSC 6500, Bethesda, Maryland 20892-6500

A -- PTH AND ALENDRONATE IN COMBINATION IN THE TREATMENT OF OSTEOPOROSIS SOL NIH-NIAMS-00-005 DUE 081000 POC Eileen Webster-Cissel, 301-594-2543 E-MAIL: Eileen Webster-Cissel, ew52c@nih.gov. The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health, intends to negotiate on a sole source basis with the University of California, San Francisco, to expand the scope of their current contract. The University of California, San Francisco, was originally awarded a contract for a five year period in October 1999 for a project entitled "PTH and Alendronate in Combination in the Treatment of Osteoporosis." The purpose of this contract is to conduct a multi-center, placebo-controlled, double-masked clinical trial to test the efficacy of combining parathyroid hormone (PTH) and alendronate in the treatment of osteoporosis. The proposed expansion in scope is to add quantitative computed tomography (QCT) measurements to the study protocol. QCT will allow the contractor to examine the effect of PTH, both alone and in combination with alendronate, on structural and biomechanical properties of bone, and on trabecular and cortical (volumetric) BMD at boththe spine and hip. A determination for the use of other than full and open competition has been made in accordance with 42 U.S.C. 253(c)(1) as set forth in FAR 6.302-1. The University of California, San Francisco, has the prerequisite knowledge and experience because of their preliminary and current work. Inherent duplication of cost to the Government and unacceptable delays in performance make competition for this additional work unfeasible. All responsible sources may submit a proposal which will be considered by the NIAMS. A determination not to compete the proposed work based upon responses to this notice is solely within the discretion of the Contracting Officer. This notice of intent is not an announcement of the availability of a Request for Proposals (RFP), nor is a RFP available. See Numbered Note 22. Posted 06/23/00 (W-SN468041). (0175)

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