Proposal To Plan A Randomized Trial Of Vertebroplasty

描述(由申请人提供)： 所提议的规划过程的总体目标是征求早期同行 回顾了随机、双盲、 经皮椎体成形术治疗颈椎病的安慰剂对照临床试验 骨质疏松性压缩骨折的治疗。这一政策的潜在影响 拟议的研究可能是实质性的，因为它涉及一项新的和很大程度上 治疗骨质疏松性压缩骨折的未研究方法 脊柱损伤，这是一个普遍、严重且代价高昂的健康问题。大的， 一般来说，多中心临床试验需要广泛的规划。建议数 临床试验将需要特别仔细的计划，因为它实际上 目前正在进行的经皮椎体成形术涉及到标签外使用 丙烯酸骨水泥和放射造影剂。出于这个原因， 拟议的试验涉及公众与公众之间复杂的业务关系 以及私营部门、科学和临床实践。具体目标是： 1.进一步完善研究设计和方案的具体方面 编写试验操作手册，包括：研究干预， 结果衡量标准、研究人群的规模、招聘地点的数量、 研究纳入和排除标准、统计数据和成本效益 分析计划，开发骨的标准化研究程序 矿物质密度测量、脊柱成像和骨折评估、医学 疼痛和骨质疏松症的管理、试验干预和发展 数据采集仪器。。 2.发展与相关联邦监管和保险部门的关系 机构(食品和药物管理局和卫生保健筹资 管理)和工业(适当的不透射线骨的制造商 水泥)以及学术和临床医学(达特茅斯和 参与临床站点)需要快速执行这方面的研究 推广调查性治疗。

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.