THE INFLUENCE OF FIVE YEARS OF EXEMESTANE ON BONE MINERAL DENSITY

五年依西美坦对骨密度的影响

• 批准号: 7952272
• 负责人: ROWAN A CHLEBOWSKI
• 金额: $ 5.12万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952272
• 关键词: Adverse effects; Aromatase Inhibitors; Biological Markers; Blood; Blood specimen; Bone Density; Canada; Cancer Etiology; Clinical; Clinical Research; Companions; Computer Retrieval of Information on Scientific Projects Database; Consent; Consent Forms; Contusions; DEXA; Disclosure; Eligibility Determination; Enrollment; Exemestane; Fracture; Funding; Grant; Hemorrhage; Hip region structure; Incidence; Institution; Instruction; Low Dose Radiation; Measurement; Minerals; National Cancer Institute of Canada Clinical Trials Group; Needles; Osteoporosis; Pain; Placebos; Population; Postmenopause; Procedures; Protocols documentation; Randomized; Research; Research Personnel; Resources; Risk; Safety; Scanning; Screening procedure; Source; Testing; United States; United States National Institutes of Health; Vertebral column; Visit; Woman; base; bone; malignant breast neoplasm

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 (project#11794-01). 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. MAP.3B subject population: MAP.3 subjects who have a Bone Mineral measurement (using DEXA) with a BMD T-score >= -1.9 SD, done within 8 weeks prior to randomization to the MAP.3 core protocol, may participate in the MAP.3B companion protocol. MAP.3B additional procedures: Taking part in MAP.3B study, two additional BMD measurements (using DEXA) of hip and spin will be performed at two and five years following enrollment. Two additional blood samples will be collected for bone biomarker tests at one and five years following enrollment. 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. To conduct MAP.3B study, a MAP.3B special informed consent form and PHI will be used for consenting and all MAP.3B related study documents will be kept in a separate study regulatory binder. Based on NCIC CTG instruction, MAP.3B companion study does not need a separate FDA F1572, Finacial disclosure form and investigator study acknowledgement form. We may use the same screening and enrollment log as MAP.3 core study use.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 MAP.3B 是 NCIC CTG MAP.3 核心研究“项目”11794-01”的配套研究。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女性乳腺癌的发病率。所有参加 MAP.3 核心研究的女性都将在 MAP.3 核心研究初次筛查访视时接受 MAP.3B 伴随研究资格筛查，如果符合资格，将受邀参加。该试验将在加拿大和加拿大进行。美国约有480名女性将参加这项研究。 研究目标是： 1. 评估骨矿物质密度“BMD”的百分比变化；随机分配至核心方案后距基线一年和五年时的脊柱和全髋关节情况； 2. 比较治疗组中脊柱或全髋骨 BMD 低于骨质疏松症绝对阈值的女性比例； 3. 比较依西美坦治疗骨质疏松症的长期临床安全性。作为核心方案的一部分，将在整个 MAP.3 人群中评估依西美坦和安慰剂对骨折发生率的影响。 MAP.3B 受试者群体：“使用 DEXA”进行骨矿物质测量的 MAP.3 受试者； BMD T 分数 >= -1.9 SD，在随机分配到 MAP.3 核心方案之前 8 周内完成，可以参与 MAP.3B 配套方案。 MAP.3B 附加程序：参加 MAP.3B 研究，“使用 DEXA”进行两次附加 BMD 测量。髋关节和旋转训练将在入组后两年和五年进行。将在入组后一年和五年收集另外两份血液样本用于骨生物标志物测试。 这是一项低风险研究。使用 DEXA 扫描进行 BMD 测量没有已知的风险或副作用。受试者将接受 DEXA 扫描的非常低剂量的辐射，并且这种扫描导致癌症的机会非常小。抽血可能会导致针插入处疼痛、出血或瘀伤。 为了进行 MAP.3B 研究，将使用 MAP.3B 特殊知情同意书和 PHI 进行同意，所有 MAP.3B 相关研究文件将保存在单独的研究监管活页夹中。根据 NCIC CTG 指令，MAP.3B 伴随研究不需要单独的 FDA F1572、财务披露表和研究者研究确认表。我们可以使用与 MAP.3 核心研究相同的筛选和登记日志。