Proposal To Plan A Randomized Trial Of Vertebroplasty

Dartmouth College, Hanover NH

Investigators

Abstract

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.