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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 女性更年期与心血管疾病风险增加有关。传统的HRT(雌激素孕激素)与心血管事件的增加有关。单靠雌激素已被证明不会增加或减少事件。然而，中风的风险略有增加。由于最近的发现，有必要研究绝经后妇女预防的替代疗法。与雌激素不同，Evista或雷洛昔芬不刺激乳房或子宫组织，这使其成为治疗绝经后妇女特有疾病的潜在选择。本研究的目的是确定Evista对血流速度的影响，这可能对心血管疾病的风险有影响。血流速度用多普勒超声的搏动指数测量。在这项研究中，女性将通过病史和体检进行筛查，然后随机分为治疗组和安慰剂组。在治疗前、治疗中、治疗2ms和6ms后测量搏动指数，以确定两组之间的外周血流速度的差异。此外，生活质量将通过使用SF36问卷进行评估。本研究将探讨Evista对患者外周血流速度的影响及其对患者生活质量的影响。Evista的假说治疗将与搏动指数的降低相关，从而增加外周动脉的血流量。此外，通过这种疗法，患者将表现出由SF36问卷评估的改善的生活质量。目的比较Evista和安慰剂对绝经后妇女外周血管血流速度的影响。第二目的比较依维斯塔与安慰剂对患者生活质量的影响。 假设 Evista的治疗将与脉搏指数的降低相关，从而增加外周动脉的血流量。此外，通过这种疗法，患者将表现出由SF36问卷评估的改善的生活质量。 首要目标 目的：探讨Evista与安慰剂对绝经后妇女外周血管血流速度的影响。 次要目标 目的：比较依维斯塔与安慰剂对患者生活质量的影响。

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.