Section XI. Osteoporosis Research Program
Osteoporosis Research Program Background
Congressional Appropriation and Funding Execution
ORP Vision and Mission
Program Accomplishments and Outcomes
Osteoporosis is a serious health concern both within and beyond the United States. Nearly 200 million people worldwide are afflicted with osteoporosis and this number may double in the next 25 years due to increased life expectancy. A complex, disabling disease that affects women and men of all ages, osteoporosis is characterized by reduced bone mass and a consequent increase in the risk of fracture. Fractures are typically observed in the hip, spine, and wrist. Although osteoporosis is a preventable, treatable disease, there are no cures, nor are all of its causes known.
The Department of Defense’s (DOD’s) Osteoporosis Research Program (ORP) was established in fiscal year 1995 (FY95) by a $5M Congressional appropriation to the U.S. Army Medical Research and Materiel Command (USAMRMC). The overall goal of the ORP is to support innovative basic and clinical research directed toward reducing the incidence and morbidity associated with the disease and improving the quality of life for patients with osteoporosis. The FY95 program was designed specifically to invigorate research in osteoporosis by fostering innovative studies that address prevention, early detection, and treatment.
In FY95, Congress appropriated $5M for peer-reviewed osteoporosis research. Table B-7 in Appendix B summarizes the directions from Congress for the ORP appropriation, the program’s withholds and management costs, and the investment strategy executed by the program. Prior to receipt of funds by the office of the Congressionally Directed Medical Research Programs (CDMRP), Congress and the DOD withheld funds for designated initiatives. The CDMRP set aside funds for the program development, scientific peer review, programmatic review, and the administration of grants/contracts through the entire period of performance up to 7 years (see Appendix B). The investment strategy executed is consistent with Congressional language and reflects the program’s vision.
The vision of the ORP is to conquer osteoporosis. The program’s mission is to prevent osteoporosis by promoting research directed toward reducing the incidence of, decreasing the morbidity of, and improving the quality of life for patients diagnosed with this disease. The ORP was designed specifically to invigorate research in osteoporosis by fostering innovative studies that addressed prevention, early detection, and treatment. Interdisciplinary research and communications were encouraged, as were military/civilian collaborations. Proposals addressing the needs of DOD personnel, minority, low-income, rural, and underrepresented populations were also encouraged, as were proposals that reduced the obstacles to widespread dissemination of proven detection, diagnostic, prevention, and therapeutic methods.
The programmatic strategy implemented in the FY95 ORP called for traditional research awards. The intent of these awards was to sponsor long-term, novel research that would result in substantial improvements in the prevention, diagnosis, and treatment of osteoporosis. The grants were intended to fund both new and established scientists across a broad spectrum of disciplines. The following five fundamental areas provided a strategic framework for the design of research projects:
- How can new techniques and opportunities for screening, diagnosis, and treatment of osteoporosis be developed?
- What are the risk factors in the development of osteoporosis? How can new risk factors be better identified?
- What is the role of lifestyle in the prevention and treatment of bone loss and stress fractures?
- What are the factors that regulate bone metabolism? Can noninvasive methods to measure bone strength and composition be improved?
- What are the effects of hormone replacement therapy on the prevention, etiology, or course of osteoporosis?
In response to the FY95 ORP Program Announcement, 105 proposals were received. Five 4-year traditional research awards were funded, encompassing a wide spectrum of bone disease. In accordance with the Congressional directive, one of the five awards was co-funded with the National Institute for Arthritis and Musculoskeletal and Skin Diseases, a leading institute for bone research. Award negotiations were completed by 30 September 1996.
——FY00 Program Plans
In FY96, the stewardship of the DOD ORP was transitioned to the Military Operational Medicine Research Program, USAMRMC. The CDMRP continues to be responsible for the management of funded FY95 ORP grants. Since these grants are entering their fourth year of funding, the CDMRP will close the files and solicit final reports from grantees during FY00.Program Initiatives
The CDMRP employed an "ultra-fast" timeline in the FY95 ORP in order to receive proposals, review them both scientifically and programmatically, and negotiate and obligate grants recommended for funding in the short time between the receipt of money and the end of the obligation period. Funds were released to the USAMRMC on 7 March 1996 and award negotiations were completed on 30 September 1996.
Preliminary research results for the ORP are promising. One study has shown that systemic FGF-1 can restore bone mass in an animal model of osteoporosis. A study examining the relationship between osteoporosis and oral bone loss, periodontal disease, and tooth loss has shown that bone loss in the hip or spine is associated with bone loss in the jaw. In a longitudinal study of bone turnover markers in women passing through menopause that builds on the Study of Women’s Health Across the Nation (funded by the National Institutes of Health), baseline bone mineral density measurements have been completed on over 2,000 women. Data are currently being collected that will elucidate the relationships between bone turnover and bone density and between bone turnover and ovarian aging, and will determine how lifestyle risk factors for osteoporosis modify these relationships.