Proposal To Plan A Randomized Trial Of Vertebroplasty

描述（由申请人提供）： 拟议规划过程的总体目标是争取早期同行 回顾随机、双盲、 经皮椎体成形术治疗腰椎间盘突出症的安慰剂对照临床试验 治疗腰椎压缩性骨折。的潜在影响 拟议的研究可能是实质性的，因为它涉及一个新的， 一种未经研究的治疗腰椎压缩性骨折的方法 脊柱的脊椎，这是一个普遍的，严重的，和昂贵的健康问题。很大， 多中心临床试验通常需要广泛的计划。拟议 临床试验将需要特别仔细的规划，因为， 目前进行的经皮椎体成形术涉及标签外使用 丙烯酸骨水泥和放射造影剂。为此该 拟议的审判涉及公众之间复杂的业务关系 私营部门、科学和临床实践。具体目标是： 1.为了进一步完善研究设计和方案的具体方面， 制定试验操作手册，包括：研究干预， 结果指标、研究人群的规模、招募中心的数量、 研究入选和排除标准、统计数据和成本效益 分析计划，制定骨标准化研究程序 矿物质密度测量，脊柱成像和骨折评估，医疗 疼痛和骨质疏松症的管理，试验干预措施， 数据收集工具。. 2.发展与相关联邦监管和保险部门的关系 美国食品药品监督管理局（FDA）和卫生保健融资（Health Care Financing） 管理）和行业（适当的不透射线骨的制造商 以及学术和临床医学（达特茅斯和 参与的临床研究中心）要求快速进行该研究 传播研究性治疗

DESCRIPTION (provided by applicant): The broad objective of the proposed planning process is to solicit early peer review of the rationale and design for a randomized, double-blind, placebo-controlled clinical trial of percutaneous vertebroplasty for the treatment of osteoporotic compression fractures. The potential impact of the proposed study might be substantial because it involves a new and largely uninvestigated approach to the treatment of osteoporotic compression fractures of the spine, which are a prevalent, serious, and costly health problem. Large, multicenter clinical trials in general require extensive planning. The proposed clinical trial will require especially careful planning because, as it is currently performed, percutaneous vertebroplasty involves the off-label use of acrylic bone cement and radiographic contrast materials. For this reason, the proposed trial involves complex operational relationships between the public and private sectors, science, and clinical practice. The specific aims are: 1. To further refine specific aspects of the study design and protocol for the development of the trial operations manual including: study interventions, outcome measures, size of the study population, number of recruiting sites, the study inclusion and exclusion criteria, statistical data and cost-effectiveness analysis plans, the development of standardized study procedures for bone mineral density measurement, spine imaging and fracture assessment, medical management of pain and osteoporosis, trial interventions, and the development of data collection instruments. . 2. To develop relationships with the relevant Federal regulatory and insurance agencies (Food and Drug Administration and Health Care Financing Administration) and industry (manufacturer of an appropriate radiopaque bone cement) as well as academic and clinical medicine (Dartmouth and the participating clinical sites) required to perform a study of this rapidly spreading investigational treatment.