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

Phase 4

Active, not recruiting

• Conditions: Fractures; Fall-related hospital presentations; Injuries and Accidents - Fractures; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12615000347561
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 16500

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of any fracture in the average of 5 years post randomisation (range 3-7 years). <br><br>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 Measures

Name	Time	Method
Fall-related hospital presentations in the average of 5 years post randomisation (range 3-7 years).<br><br>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]