COMBINATION THERAPIES FOR OSTEOPOROSIS

Release Date:  February 4, 1999

RFP AVAILABLE:  NIH-NIAMS-BAA-99-01

P.T.

National Institute of Arthritis and Musculoskeletal and Skin Diseases 

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.

INQUIRIES

Inquiries may be directed to:

Eileen D. Webster-Cissel
Contracts Management Branch, EP
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS13A, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-2543
FAX:  (301) 480-5996
Email:  ew52c@nih.gov

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