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.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 MAP.3B是NCIC CTG MAP.3核心研究项目的配套研究，项目35；11794-01。这项核心研究是评估芳香酶抑制剂依西美坦是否会降低绝经后女性的乳腺癌发病率。所有参加MAP.3核心研究的女性将在MAP.3核心研究的初始筛查访问中对MAP.3B同伴研究资格进行筛查，如果符合条件，将邀请他们参加。这项试验将在加拿大和美国进行，约480名女性将参加这项研究。 研究的目标是：1.评估随机对照核心方案后一年和五年脊柱和全髋骨密度的百分比变化；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人群上评估依西美坦和安慰剂对骨折发生率的影响。 MAP.3B受试者人群：MAP.3受试者可以参加MAP.3核心方案的随机化前8周内进行的MAP.3骨矿测量(使用DEXA；41；BMD T-Score；&&35；61；-1.9 SD)。 MAP.3B附加程序：参加MAP.3B研究，将在登记后两年和五年内使用DEXA和SPIN进行两次额外的骨密度测量。在注册后的一年和五年内，将额外采集两个血液样本进行骨生物标志物测试。 这是一项低风险的研究。目前尚无已知的DEXA扫描骨密度测量的风险或副作用。受试者将接受来自DEXA扫描的非常低剂量的辐射，而且这种扫描致癌的可能性非常小。抽血的影响可能会导致针头插入部位疼痛、出血或瘀伤。 要进行MAP.3B研究，将使用MAP.3B特别知情同意书和PHI表示同意，所有与MAP.3B相关的研究文件将保存在单独的研究法规活页夹中。根据NCIC CTG说明，MAP.3B配对研究不需要单独的FDA F1572、财务披露表格和研究人员研究确认表。我们可以使用与MAP.3核心研究相同的筛选和注册记录。