THE INFLUENCE OF FIVE YEARS OF EXEMESTANE ON BONE MINERAL DENSITY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 MAP.3B是NCIC CTG MAP.3核心研究的伴随研究。核心研究正在评估芳香酶抑制剂依西美坦是否会降低绝经后妇女的乳腺癌发病率。入组MAP.3核心研究的所有女性将在其MAP.3核心研究初始筛选访视时接受MAP.3B伴随研究合格性筛选，如果合格，则邀请其参加。这项试验将在加拿大和美国进行，大约480名妇女将参加这项研究。 本研究的目的是：1.评估随机分配至核心方案后1年和5年时脊柱和全髋关节骨矿物质密度（BMD）相对于基线的百分比变化; 2.比较治疗组中脊柱或全髋骨密度低于骨质疏松症绝对阈值的女性比例; 3.比较西美坦在骨质疏松症方面的长期临床安全性。作为核心方案的一部分，将在整个MAP.3人群中评价乌司美坦和安慰剂对骨折发生率的影响。 这是一项低风险研究。DEXA扫描的BMD测量没有已知的风险或副作用。受试者将从DEXA扫描中接受非常低剂量的辐射，这种扫描导致癌症的机会非常小。抽血的影响可能会导致疼痛、出血或针头插入处的瘀伤。

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. MAP.3B is a companion study to the NCIC CTG MAP.3 core study. The core study is evaluating whether an aromatase inhibitor, exemestane, will reduce breast cancer incidence in postmenopausal women. All women who enroll in the MAP.3 core study will be screened for MAP.3B companion study eligibility at their MAP.3 core study initial screening visit and, if eligible, invited to participate. This trial will be conducted in Canada and the United States and about 480 women will take part in this study. The study objectives are: 1. to assess the percentage change of Bone Mineral Density (BMD) of the spine and total hip at one and five years from baseline after randomization to the core protocol; 2. to compare the proportion of women who develop BMD of the spine or total hip below the absolute threshold value for osteoporosis in the treatment groups and 3. to compare the long term clinical safety of exemestane with respect to osteoporosis. The effect on fracture incidence between exemestane and placebo will be evaluated on the entire MAP.3 population as part of the core protocol. This is a low risk study. There are no known described risks or side effects to the BMD measurements with DEXA scan. The subject will receive a very low dose of radiation from DEXA scan and the chance of this scan causing cancer is very small. The effects of drawing blood may cause pain, bleeding or bruise where the needle is inserted.