None listed
Conditions
Brief summary
Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. During 2007, there were an average 262 fracture-related hospitalisations per day in Australia with the financial burden associated with direct treatment cost for fractures in Australia estimated at $1.9billion per year. A small number of low-quality observational studies examining the effect of aspirin on fracture risk in older people have demonstrated conflicting results. A large-scale controlled trial is required to provide more accurate information on this effect. The ASPREE-Fracture sub-study aims to investigate whether daily low-dose aspirin (100mg) is associated with decreased incidence of vertebral, hip and non-vert-non-hip fractures in healthy men and women aged 70 years and over; and whether the reduced fracture risk is explained, in part, by reducing risk of fall-related hospital presentations. The ASPREE-Fracture sub-study has the potential to change current fracture prevention practice and policies for older people by offering a population intervention. Even if small impacts are observed on fracture incidence, the net benefits of aspirin in terms of reduced fracture risk at a population level may be substantial.
Interventions
This study is a double-blind, randomised placebo-controlled trial and a sub-study of the ASPirin in Reducing Events in the Elderly trial (ASPREE, ClinicalTrials.gov identifier NCT01038583, website www.aspree.org).
ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial that is examining the benefits and risks of low-dose aspirin in 19,000 healthy people (16,500 aged 70 years and over from Australia and 2,500 people aged 65 years and over from the US) without overt card
This study is a double-blind, randomised placebo-controlled trial and a sub-study of the ASPirin in Reducing Events in the Elderly trial (ASPREE, ClinicalTrials.gov identifier NCT01038583, website www.aspree.org). ASPREE is a double-blind, randomised, placebo-controlled primary prevention trial that is examining the benefits and risks of low-dose aspirin in 19,000 healthy people (16,500 aged 70 years and over from Australia and 2,500 people aged 65 years and over from the US) without overt cardiovascular disease or dementia. The primary aim of ASPREE is to determine whether low-dose aspirin (100mg enteric coated, daily) will prolong disability and dementia free survival; and provides a net benefit for older people in a primary prevention setting. The ASPREE-Fracture sub-study will mirror the design of the ASPREE principal trial and extends current ASPREE data collection to include fracture events and fall-related hospital presentation events from all participants from the beginning of the study. The ASPREE-Fracture sub-study aims to determine the effect of daily low-dose aspirin on fracture risk (primary outcome) and falls resulting in a hospital presentation (secondary outcome) in the 16,500 ASPREE participants recruited in Australia. Participants in the ASPREE principal trial are allocated to one of two treatments (intervention and placebo). The intervention group participants will receive a once daily dose of 100mg enteric-coated aspirin for an average of 5 years post randomisation (range 3-7 years). Compliance and retention of the intervention is maintained through research staff direct phone contact every 3 months, interspersed with annual face-to-face visits.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants will be included in the ASPREE-Fracture sub-study if they are enrolled in the Australian arm of the ASPREE principal trial. The inclusion criteria for the ASPREE principal trial are: (1) aged 70 years and over; and (2) able and willing to provide informed consent.
Exclusion criteria
Participants will be excluded from the ASPREE trial, and therefore this sub-study, if they have: (1) a history of a diagnosed cardiovascular disease event or stroke; (2) a clinical diagnosis of arterial fibrillation; (3) a serious inter-current illness likely to cause death within the next 5 years; (4) a current or recurrent condition with a high risk of major bleeding; (5) anaemia; (6) current continuous use of aspirin or other anti-platelet drug or anticoagulant; (7) an absolute contraindication to or allergy to aspirin; (8) a systolic blood pressure greater than or equal to 180 mmHg or diastolic blood pressure greater than or equal to 105 mmHg; (9) a history of dementia or a Modified Mini-Mental State Examination score less than or equal to 77; (10) an inability to perform any one of the six Katz ADL’s [26]; (11) a pill-taking compliance outside the range of 80- 100% during placebo run-in phase; or (12) are currently participating in another clinical trial.
Outcome results
None listed