This page provides study documentation for BA7. For description of the specimen results, see Specimen Results Description (open to public). Data sets of the specimen results are included in the existing WHI datasets located on the WHI Data on this site (sign in and a completed Data Distribution Agreement are required; see details on the Data site).
Investigator Names and Contact Information
Steven R Cummings, M.D, California Pacific Medical Center, San Francisco
The investigators will study how baseline levels of the estrogen molecule, estradiol, and of sex hormone binding globulin (SHBG), a protein that binds to testosterone and estradiol, relate to treatment effects of hormone therapy on coronary heart disease (CHD), stroke, blood clots, fractures, breast cancer, dementia, and mild cognitive impairment. The team will test for interaction of baseline hormone levels with treatment effects of hormone therapy.
Postmenopausal women with extremely low endogenous estradiol (E2) levels have different risks of major diseases (breast cancer, fracture, stroke, cognitive impairment) than women with high levels. Estrogen therapy (estrogen alone (E-alone) and estrogen plus progestin (E+P)) is likely to have different effects on these conditions in those with extremely low levels than those with relatively high E2 levels. For example, estrogen therapy may substantially increase the risk of stroke in women with low E2 levels and low risk of stroke but may not increase the risk of stroke in women who have high E2 levels and relatively high stroke risk at the start. Therefore, we will test the hypothesis that the effects of estrogen therapies depend on baseline E2 levels.
1 - Fink HA, Ensrud KE, Nelson DB, et al.: Disability after clinical fracture in postmenopausal women with low bone density: the fracture intervention trial (FIT). Osteoporos Int 2003; 14(1): 69-76.