EFFECT OF IDOXIFENE ON BONE HISTOMORPHOMETRY IN POSTMENOPAUSAL WOMEN

艾多昔芬对绝经后女性骨组织形态学的影响

• 批准号: 6309843
• 负责人: KAREN M PRESTWOOD
• 金额: $ 1.91万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6309843
• 关键词: biopsy; bone density; bone metabolism; clinical research; drug adverse effect; estrogen inhibitor; female; histology; human subject; human therapy evaluation; postmenopause; tamoxifen; tetracyclines

This is an open label, two-center trial in which 10 mg of idoxifene will be administered daily for two years to postmenopausal women. Each woman will act as her own control and comparisons will be made between the histomorphometric parameters of the bone biopsy at baseline and during treatment. Thin needle bone biopsies of the iliac crest will be performed at baseline and at yearly intervals. Before each biopsy the patient will take a short course of tetracycline at defined intervals to provide bone labeling for determination of dynamic histomorphometry values. All biopsies will be processed and sectioned to provide a preliminary assessment of the quality of the tissue. This analysis will determine whether or not the biopsy will yield sufficient information to calculate the activation frequency. The biopsies will be fully evaluated by a blinded reviewer, who is not aware of the chronological order of the biopsies, at the end of the study. The hypothesis being tested is that idoxifene will have estrogenic effects on bone histomorphometry in postmenopausal women with high bone turnover without having adverse effects on bone quality.

这是一项开放标签的双中心试验，绝经后妇女每天服用10mg伊多昔芬，持续两年。每位妇女将作为自己的对照，并比较基线和治疗期间骨活检的组织形态学参数。将在基线和每年间隔进行髂嵴细针骨活检。在每次活检之前，患者将在规定的时间间隔内接受短期四环素治疗，以提供骨标记，以确定动态组织形态学值。所有活组织检查将被处理和切片，以提供组织质量的初步评估。这种分析将决定活检是否会产生足够的信息来计算激活频率。在研究结束时，活检将由一位不知道活检时间顺序的盲法审稿人进行全面评估。正在测试的假设是，伊多昔芬将对绝经后高骨转换妇女的骨组织形态测量产生雌激素效应，而不会对骨质量产生不良影响。