title: A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: protocol for the ASPREE-Fracture substudy.
abstract: Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. Observational studies suggest that aspirin may reduce fracture risk. While these studies provide room for optimism, randomised controlled trials are needed. This paper describes the rationale and design of the ASPirin in Reducing Events in the Elderly (ASPREE)-Fracture substudy, which aims to determine whether daily low-dose aspirin decreases fracture risk in healthy older people.
  
  
  
  ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial designed to assess whether daily active treatment using low-dose aspirin extends the duration of disability-free and dementia-free life in 19 000 healthy older people recruited from Australian and US community settings. This substudy extends the ASPREE trial data collection to determine the effect of daily low-dose aspirin on fracture and fall-related hospital presentation risk in the 16 500 ASPREE participants aged ≥70 years recruited in Australia. The intervention is a once daily dose of enteric-coated aspirin (100 mg) versus a matching placebo, randomised on a 1:1 basis. The primary outcome for this substudy is the occurrence of any fracture-vertebral, hip and non-vert-non-hip-occurring post randomisation. Fall-related hospital presentations are a secondary outcome.
  
  
  
  This substudy will determine whether a widely available, simple and inexpensive health intervention-aspirin-reduces the risk of fractures in older Australians. If it is demonstrated to safely reduce the risk of fractures and serious falls, it is possible that aspirin might provide a means of fracture prevention.
  
  
  
  The protocol for this substudy is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000347561).
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
authors.forename: Anna L
authors.initials: AL
authors.lastname: Barker
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
authors.forename: John J
authors.initials: JJ
authors.lastname: McNeil
authors.affiliation: Department of Endocrinology and Medicine, Austin Health, University of Melbourne, Melbourne, Australia.
authors.forename: Ego
authors.initials: E
authors.lastname: Seeman
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia Monash Ageing Research Centre (MONARC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
authors.forename: Stephanie A
authors.initials: SA
authors.lastname: Ward
authors.affiliation: Department of Medicine, NorthWest Academic Centre, University of Melbourne, Melbourne, Australia Institute for Health and Ageing, Australian Catholic University, Melbourne, Australia.
authors.forename: Kerrie M
authors.identifier: 0000-0002-2718-6592
authors.initials: KM
authors.lastname: Sanders
authors.affiliation: Endocrine Research Unit, College of Medicine, Mayo Clinic, Rochester, USA.
authors.forename: Sundeep
authors.initials: S
authors.lastname: Khosla
authors.affiliation: School of Public Health, University of Sydney, Sydney, Australia.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Cumming
authors.affiliation: Department of Medicine, NorthWest Academic Centre, University of Melbourne, Melbourne, Australia Epi-Centre for Healthy Ageing, School of Medicine, Deakin University, Geelong, Australia.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Pasco
authors.affiliation: Department of Medicine, Melbourne EpiCentre, University of Melbourne, Melbourne, Australia.
authors.forename: Megan A
authors.initials: MA
authors.lastname: Bohensky
authors.affiliation: Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Australia.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Ebeling
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
authors.forename: Robyn L
authors.initials: RL
authors.lastname: Woods
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
authors.forename: Jessica E
authors.initials: JE
authors.lastname: Lockery
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
authors.forename: Rory
authors.initials: R
authors.lastname: Wolfe
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
authors.forename: Jason
authors.initials: J
authors.lastname: Talevski
mesh_terms: D000058:Accidental Falls / Q000706:statistics & numerical data*; D000203:Activities of Daily Living; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000494:pharmacology*; D001315:Australia / Q000453:epidemiology; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage* / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control*; D006801:Humans; D008297:Male; D064887:Observational Studies as Topic; D011322:Primary Prevention / Q000379:methods; D012648:Self Care; D014481:United States / Q000453:epidemiology
chemical_list: D016861:Cyclooxygenase Inhibitors; D001241:Aspirin