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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。女性更年期与心血管疾病的风险增加有关。传统的HRT（雌激素+黄体酮）与CVD事件的增加有关。单独雌激素已被证明不会增加或减少事件。然而，有一个小的增加中风的风险。由于最近的发现，有必要研究预防绝经后妇女的替代疗法。与雌激素相比，Evista或雷洛昔芬不会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，血流速度可能对心血管疾病的风险有影响。血流速度用多普勒超声心动图测量脉搏指数。在这项研究中，女性将通过病史和体格检查进行筛选，然后随机分为治疗组和安慰剂组。将在基线、治疗期间和治疗后2和6 ms测量脉搏指数，以确定两组之间外周血血流速度的差异。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对外周血血流速度的影响及其对患者生活质量的影响。假设使用Evista治疗会降低脉搏指数，从而增加外周动脉的血流量。此外，通过SF36问卷评估，患者将表现出生活质量的改善。主要目的探讨Evista与安慰剂对绝经后妇女外周血管血流速度的影响。次要目的：比较Evista与安慰剂对患者质量的影响

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 quali