Anna L Barker1, John J McNeil1, Ego Seeman2, Stephanie A Ward3, Kerrie M Sanders4, Sundeep Khosla5, Robert G Cumming6, Julie A Pasco7, Megan A Bohensky8, Peter R Ebeling9, Robyn L Woods1, Jessica E Lockery1, Rory Wolfe1, Jason Talevski1. 1. Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. 2. Department of Endocrinology and Medicine, Austin Health, University of Melbourne, Melbourne, Australia. 3. 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. 4. Department of Medicine, NorthWest Academic Centre, University of Melbourne, Melbourne, Australia Institute for Health and Ageing, Australian Catholic University, Melbourne, Australia. 5. Endocrine Research Unit, College of Medicine, Mayo Clinic, Rochester, USA. 6. School of Public Health, University of Sydney, Sydney, Australia. 7. Department of Medicine, NorthWest Academic Centre, University of Melbourne, Melbourne, Australia Epi-Centre for Healthy Ageing, School of Medicine, Deakin University, Geelong, Australia. 8. Department of Medicine, Melbourne EpiCentre, University of Melbourne, Melbourne, Australia. 9. Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Australia.
Abstract
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). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
RCT Entities:
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 ASPREEparticipants 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). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Authors: Julie A Pasco; Mark A Kotowicz; Margaret J Henry; Geoffrey C Nicholson; Heather J Spilsbury; Jeffrey D Box; Hans G Schneider Journal: JAMA Date: 2006-09-20 Impact factor: 56.272
Authors: Russel Burge; Bess Dawson-Hughes; Daniel H Solomon; John B Wong; Alison King; Anna Tosteson Journal: J Bone Miner Res Date: 2007-03 Impact factor: 6.741
Authors: Jane A Cauley; John Robbins; Zhao Chen; Steven R Cummings; Rebecca D Jackson; Andrea Z LaCroix; Meryl LeBoff; Cora E Lewis; Joan McGowan; Joan Neuner; Mary Pettinger; Marcia L Stefanick; Jean Wactawski-Wende; Nelson B Watts Journal: JAMA Date: 2003-10-01 Impact factor: 56.272
Authors: L Sànchez-Riera; E Carnahan; T Vos; L Veerman; R Norman; S S Lim; D Hoy; E Smith; N Wilson; J M Nolla; J S Chen; M Macara; N Kamalaraj; Y Li; C Kok; C Santos-Hernández; L March Journal: Ann Rheum Dis Date: 2014-04-01 Impact factor: 19.103
Authors: Sultana Monira Hussain; Michael E Ernst; Anna L Barker; Karen L Margolis; Christopher M Reid; Johannes T Neumann; Andrew M Tonkin; Thao Le Thi Phuong; Lawrence J Beilin; Thao Pham; Enayet K Chowdhury; Flavia M Cicuttini; Julia F M Gilmartin-Thomas; Prudence R Carr; John J McNeil Journal: Hypertension Date: 2022-06-20 Impact factor: 9.897