A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: the ASPREE-Fracture sub-study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000347561
• Date of registration: 16/04/2015
• Prospective Registration: No
• Primary sponsor: Monash University
• Public title: A randomised controlled trial of low-dose aspirin for the prevention of fractures in healthy older people: the ASPREE-Fracture sub-study
• Scientific title: A double-blind, randomised, placebo-controlled trial to determine the effects of daily low-dose aspirin (100mg) versus placebo on the risk of fractures and fall-related hospital presentations in healthy older adults aged 70 years and over
• Date of first enrolment: 04/01/2010
• Target sample size: 16500
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12615000347561.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: A/Prof Anna Barker

• Name: Mr Jason Talevski

Key inclusion & exclusion criteria

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.

Age minimum: 70 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Fractures;Fall-related hospital presentations;
Fractures
Fall-related hospital presentations

Injuries and Accidents - Other injuries and accidents

Injuries and Accidents - Fractures

Intervention(s)

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.

Primary Outcome(s)

Occurrence of any fracture in the average of 5 years post randomisation (range 3-7 years).

A fracture event will be defined as any type of vertebral, hip and non-vert-non-hip fracture (including traumatic and pathological) confirmed by medical imaging (e.g. x-ray). Data on fracture events will be collected via annual face-to-face visits with study participants; 6-monthly interviewer administered questionnaires (designed specifically for this study) through telephone contact; and audit of hospital, general practice and specialist medical records—including hospital admission notes, hospital discharge summaries, medical imaging reports (x-rays, MRI, CT and bone scan reports), ED progress notes and death certificates.[5 years post randomisation]

Secondary Outcome(s)

Fall-related hospital presentations in the average of 5 years post randomisation (range 3-7 years).

A fall-related hospital presentation event will be defined as ‘any event which results in a person coming to rest inadvertently on the ground or floor or lower level’ that results in a hospital presentation (including emergency department presentations and hospital admissions). Data on fall-related hospital presentation events will be collected via annual face-to-face visits with study participants; 6-monthly interviewer administered questionnaires (designed specifically for this study) through telephone contact; and audit of hospital, general practice and specialist medical records—including hospital admission notes, hospital discharge summaries, ED progress notes and death certificates. [5 years post randomisation]

Secondary ID(s)

Nil

Source(s) of Monetary Support

National Health and Medical Research Council (NHMRC)

Ethics review

Status: Approved
Approval date:
Contact:

Monash University Human Research Ethics Committee