EFFECT OF IDOXIFENE ON BONE HISTOMORPHOMETRY IN POSTMENOPAUSAL WOMEN

这是一项开放标签、双中心试验，其中每天给予绝经后妇女10 mg艾多昔芬，持续两年。 每名女性将作为自己的对照，并将在基线和治疗期间进行骨活检的组织形态计量学参数之间的比较。 将在基线时和每年间隔进行髂嵴细针骨活检。 每次活检前，患者将在规定的时间间隔接受短期四环素治疗，以提供骨标记，用于测定动态组织形态计量学值。 将对所有活检进行处理和切片，以提供组织质量的初步评估。 该分析将确定活检是否将产生足够的信息来计算激活频率。 在研究结束时，将由不了解活检时间顺序的盲态审查员对活检进行全面评价。正在检验的假设是，艾多昔芬将对高骨转换的绝经后妇女的骨组织形态计量学产生雌激素效应，而不会对骨质量产生不良影响。

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.