RT Journal Article
SR Electronic
T1 A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: protocol for the ASPREE-Fracture substudy
JF Injury Prevention
JO Inj Prev
FD BMJ Publishing Group Ltd
SP 297
OP 301
DO 10.1136/injuryprev-2015-041655
VO 22
IS 4
A1 Anna L Barker
A1 John J McNeil
A1 Ego Seeman
A1 Stephanie A Ward
A1 Kerrie M Sanders
A1 Sundeep Khosla
A1 Robert G Cumming
A1 Julie A Pasco
A1 Megan A Bohensky
A1 Peter R Ebeling
A1 Robyn L Woods
A1 Jessica E Lockery
A1 Rory Wolfe
A1 Jason Talevski
YR 2016
UL http://injuryprevention.bmj.com/content/22/4/297.abstract
AB Background 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.Methods 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.Discussion 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.Trial registration number The protocol for this substudy is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000347561).