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 -- COMBINATION THERAPIES FOR OSTEOPOROSIS SOL NIH-NAIMS-BAA-99-01 POC Eileen D. Webster-Cissel, Chief, Contracts Management Branch, NIAMS, 301/594-2543 The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) hereby announces the availability of a Broad Agency Announcement (BAA) which describes in general terms a research topic and outlines proposal preparation requirements. The purpose of this BAA is to solicit proposals for research which will increase clinical application of knowledge gained from basic research on bone diseases. The goal of this initiative is to uncover which combination therapies for osteoporosis optimize improvements in bone mass and bone strength while minimizing deleterious side effects. To achieve the main goal of this BAA, the NIAMS seeks to support randomized trials of combinations of therapeutic agents for osteoporosis. Trials can be either a pilot or Phase I/II trial to assess safety and determine if an intervention shows promising effects which warrant further evaluation. These trials can include evaluation of either biochemical, radiologic, or other surrogate markers in order to study the mechanisms underlying the intervention and mechanisms of disease pathogenesis. Because there are studies currently underway to test the anti-fracture efficacy of estrogen, this solicitation has restricted its use to low doses in combinations. Similarly, calcium and exercise, while important in maintaining bone mass and preventing fractures, are not acceptable interventions for the purpose of this solicitation. In addition, in the context of the clinical trials, NIAMS is also seeking mechanistic substudies which utilize the patients and patient materials from the trial for the evaluation of the mechanisms of disease pathogenesis, surrogate markers of disease activity, and therapeutic effect. The NIAMS is particularly interested in the application of new technologies and approaches in these studies. It is anticipated that one to three cost reimbursement contract awards will be made for a maximum period of five years beginning on or about September 30, 1999. The solicitation NIH-NIAMS-BAA-99-01 will be available electronically on or about February 12, 1999 and may be accessed through the Internet at the following address: http://www.nih.gov/niams/grants/rfp/rfplist.htm. Proposals will be due on or about April 13, 1999. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet site for any possible solicitation amendments that may be issued by the Government. All responsible sources may submit proposals which will be considered by the Government. This advertisement does not commit the Government to award a contract.***** Posted 01/27/99 (W-SN292082). (0027)

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