PROSP, RNDOM, PLACEBO-CNTR STUDY OF EFFECT OF EVISTA ON PBF VEL IN PM WOMEN

这个子项目是众多研究子项目之一

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Menopause in women has been associated with an increased risk of cardiovascular disease. Conventional HRT (Estrogen + Progestin) has been associated with an increase in CVD events. Estrogen alone has been shown to not increase or decrease events. However there is a small increased risk of stroke. Because of recent findings there is a need to study alternative therapies for prevention in postmenopausal women. Evista, or Raloxifene, in contrast to estrogen, does not stimulate breast or uterine tissues, which makes it a potential option for treatment of conditions characteristic of postmenopausal women. The purpose of this study is to determine the effect of Evista on blood flow velocity, which may have an effect on the risk of cardiovascular disease. Blood flow velocity is measured by pulsatility index with the use of the Doppler ultrasound. In this study, women will be screened by medical history and physical examination, and then randomized to either the treatment or placebo arm. Pulsatility indices will be measured at baseline, during, and after 2 and 6 ms of treatment, to determine differences in peripheral blood flow velocity between the two groups. Also, quality of life will be assessed by the use of the SF36 questionnaire. This study will investigate the effect of Evista on peripheral blood flow velocity as well as its effect on patient quality of life. Hypothesis Treatment with Evista will be associated with a reduction of the pulsatility indices and therefore an increase in blood flow in the peripheral arteries. Also, with this therapy, patients will exhibit an improved quality of life as assessed by the SF36 questionnaire. Primary Objective To investigate the effect of Evista compared to placebo on peripheral vascular blood flow velocity in postmenopausal women. Secondary Objective To investigate the effect of Evista compared to placebo on patient quality of life. Hypothesis Treatment with Evista will be associated with a reduction of the pulsatility indices and therefore an increase in blood flow in the peripheral arteries. Also, with this therapy, patients will exhibit an improved quality of life as assessed by the SF36 questionnaire. Primary Objective To investigate the effect of Evista compared to placebo on peripheral vascular blood flow velocity in postmenopausal women. Secondary Objective To investigate the effect of Evista compared to placebo on patient quality of life.