title: Study design considerations for a large simple trial of bisphosphonates.
abstract: OBJECTIVE
  To evaluate design considerations for an osteoporosis large simple trial (LST).
  
  
  RESULTS
  There is a growing need for more comparative effectiveness studies in osteoporosis. However, the design of such studies is challenged by issues surrounding study design, choosing comparator therapies, participant and outcome selection, data acquisition and data analysis.
  
  
  CONCLUSIONS
  LSTs are real-world studies that can have high levels of generalizability, if designed properly. We propose novel approaches to LSTs focusing on some of the challenges associated with comparative effectiveness research in osteoporosis. In this review, we discuss these considerations in the context of bisphosphonate active comparator initiation and discontinuation trials, while presenting advantages and disadvantages of the various design aspects for such studies.
authors: Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama 35294, USA. ncwright@uab.edu
authors: Nicole C
authors: NC
authors: Wright
authors: Amy H
authors: AH
authors: Warriner
authors: Kenneth G
authors: KG
authors: Saag
mesh_terms: D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D057186:Comparative Effectiveness Research / Q000379:methods*; D004164:Diphosphonates / Q000627:therapeutic use*; D006801:Humans; D010024:Osteoporosis / Q000188:drug therapy*; D018579:Patient Selection; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates