USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-89-223

Project Title:

Black and White Races, Body Composition and Osteoporosis

Principle Investigator: Dr. Ruimei Ma

Project started in: 1989

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

Non-Federal: St. Luke's Roosevelt Hospital

Amount: $124,000 (Est.)
Comments:

Funding is a subcontract from St. Luke's Roosevelt Hospital, whose research is funded by National Institute of Diabetes and Digestive and Kidney Disease (NIDDK).

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: July 12, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 58
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For clinical research.

Internal administration of radioactive substances to human subjects.

• For clinical research.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

• Use of bodily materials collected from subjects specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

The long term objective of this study is to develop strategies for the prevention of osteoporosis in black women. Since osteoporosis has been a greater public health problem in white women, most studies have excluded racial minorities to limit extraneous variation. However, the number of black women over 65 years of age is increasing rapidly. Since hip fracture incidence rates increase exponentially after menopause, an increase in longevity of 5-6 years is expected to cause a doubling of incidence rates. Three hundred black and white women between the ages of 20 and 80 years will be studied. Each of these subjects will undergo total body calcium determination. Sixty subjects will have baseline measurements of total body nitrogen and total body water. These subjects will return on an annual basis for five years, but will only have total body calcium determination on each subsequent visit. Elemental body composition, including total body calcium, will be determined by whole body counting, in vivo neutron activation analysis and tritiated water dilution method. Subjects will be exposed to ionizing radiation including neutrons, gamma-rays and electrons. Subjects will be given tritiated water by mouth. A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses.