A Simulation Tool to Evaluate Calcium-41 Experimental Study Designs

评估 Calcium-41 实验研究设计的模拟工具

• 批准号: 9332814
• 负责人: Courtney Henry
• 金额: $ 3.55万
• 依托单位: PURDUE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9332814
• 关键词: Address; Administrative Supplement; Affect; Alternative Therapies; Animal Model; Animals; Applications Grants; Berry; Biological; Bone Density; Bone Diseases; Bone Resorption; Calcium; Communication; Complementary therapies; Crossover Design; Data Set; Dietary Intervention; Disease; Effectiveness; Environment; Estrogens; Experimental Designs; Fracture; Future; Goals; Grant; Growth; Health; Hormone replacement therapy; Human; Incidence; Integrative Medicine; Intervention; Isotopes; Lifestyle Therapy; Measures; Mentorship; Metabolic Bone Diseases; Methodology; Modeling; Monitor; Nutritional Support; Oral; Osteoporosis; Output; Postmenopause; Production; Property; Public Health; Rattus; Reporting; Research; Research Design; Research Personnel; Research Training; Risk; Sample Size; Sampling; Science; Scientist; Strategic Planning; Structure; Study models; Targeted Research; Techniques; Time; Tracer; Training; Translational Research; Treatment Efficacy; United States National Institutes of Health; Woman; Workload; Writing; accelerator mass spectrometry; base; bone; bone health; bone loss; bone strength; calcium metabolism; career; cost; cost effective; design; dietary supplements; experimental study; improved; lifestyle intervention; method development; next generation; novel; older women; prevent; programs; public health relevance; research study; response; screening; simulation; skeletal; skills; skills training; tool; treatment effect; urinary

Project Summary/Abstract Osteoporosis is a progressive bone disease that reduces bone mineral density (BMD) leading to an increased risk of bone fracture. It largely affects women post-menopause who incur a sharp decline in estrogen production, which has a key role in the proper growth and maturation of bone. Alternative and integrative health approaches for preventing disease occurrence, primarily through use of natural dietary supplements, are currently being sought due to the adverse health risks associated with conventional hormone replacement therapies. To assess the effectiveness of these disease interventions, a well-established novel and sensitive screening technique incorporating a biological tracer, calcium-41 (41Ca), is used to rapidly and sensitively monitor bone resorption. Measured is the urinary 41Ca:Ca isotope ratio, monitored by Accelerator Mass Spectrometry (AMS) to detect changes in bone calcium metabolism. This study proposes to develop a 41Ca simulation study to serve as a tool to investigate how inputs of sample size, number of control periods, and number of control samples per period will affect the output: (1) the accuracy (standard error) of reported mean estimates of treatment effect (2) the power of the study to detect given effect sizes and (3) the cost of the experimental study. Ultimately, this tool will determine “optimal” 41Ca experimental designs, which are uniquely defined as the most efficient study designs that preserve the accuracy and reliability of the original experimental estimates but require a reduced number of experimental samples, which notably provides a cost reduction. In parallel, this study proposes to develop a 45Ca simulation tool using the ovariectomized (OVX) rat model to determine the optimal experimental design for treatment efficacy on bone calcium retention. Ultimately, these new designs will be implemented to further increase the practicality and utility of 41Ca and 45Ca methodology in future translational research studies, targeted to reduce the risk of osteoporosis. This proposal specifically addresses the 2016 NCCIH strategic plan Objective 1: Advance Fundamental Science and Method Development, by creating a novel research study tool for strengthening (statistical power) the experimental design of human and animal trials of alternative and complementary health approaches. In addition, this proposal will provide the necessary research training skills and mentorship opportunities for effective scientific communication through grant and proposal writing, oral presentations, and participation in collaborative research environments and science diversity mentorship programs. I anticipate that by acquiring these skills and opportunities, I will be successful in a professional career as independent research scientist.

项目概要/摘要 骨质疏松症是一种进行性骨病，会降低骨矿物质密度 (BMD)，导致骨密度增加 它主要影响雌激素急剧下降的绝经后女性。 生产，这对于骨骼的正常生长和成熟具有关键作用。 主要通过使用天然膳食补充剂来预防疾病发生的健康方法， 由于传统激素替代疗法存在不良健康风险，目前正在寻求解决方案 为了评估这些疾病干预措施的有效性，需要一种行之有效的新颖且敏感的疗法。 结合生物示踪剂钙 41 (41Ca) 的筛选技术可快速、灵敏地 监测骨吸收，测量尿 41Ca:Ca 同位素比，通过加速器质量监测。 光谱法（AMS）检测骨钙代谢的变化。 本研究建议开发 41Ca 模拟研究，作为研究样本输入如何进行的工具 大小、控制周期数以及每个周期的控制样本数将影响输出： (1) 报告的治疗效果平均估计的准确性（标准误差） (2) 研究检测的能力 给定效应大小和 (3) 实验研究的成本，该工具最终将确定“最佳”41Ca。 实验设计，被独特地定义为最有效的研究设计，可以保留 原始实验估计的准确性和可靠性，但需要减少实验次数 同时，本研究建议开发 45Ca 模拟。 使用卵巢切除 (OVX) 大鼠模型来确定最佳治疗实验设计的工具 最终，这些新设计将进一步提高骨钙保留的功效。 41Ca 和 45Ca 方法在未来转化研究中的实用性和实用性，旨在减少 骨质疏松症的风险。 该提案专门针对 2016 年 NCCIH 战略计划目标 1：推进基本面 科学和方法开发，通过创建一种新颖的研究工具来加强（统计能力） 替代和补充健康方法的人体和动物试验的实验设计。 此外，该提案将为以下人员提供必要的研究培训技能和指导机会： 通过资助和提案撰写、口头演讲以及参与 我预计通过获得合作研究环境和科学多样性指导计划。 这些技能和机会，我将在作为独立研究科学家的职业生涯中取得成功。