Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000754741
Ethics application status
Approved
Date submitted
3/07/2013
Date registered
5/07/2013
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The ASPREE-Knee Sub-study: Does aspirin slow the progression of knee structural damage in adults over 70 years of age?
Scientific title
The ASPREE-Knee Sub-study: Does aspirin slow the progression of knee structural damage in adults over 70 years of age?
Secondary ID [1] 282758 0
Nil
Universal Trial Number (UTN)
Trial acronym
ASPREE-Knee Sub-study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 289498 0
Condition category
Condition code
Musculoskeletal 289830 289830 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study, the ASPREE Knee Sub-study, is a sub study of the Aspirin in Reducing Events in the Elderly study (ASPREE, ClinicalTrials.gov identifier NCT01038583, website www.aspree.org). ASPREE is a double blinded, randomised controlled trial of low dose daily aspirin, 100mg oral tablets versus placebo, taken daily for a mean of five years in healthy participants aged 70 and over, followed over a mean of 5 years for the primary outcomes of dementia-free survival and disability-free survival. It is a primary prevention study.

The ASPREE Knee Sub-study will involve a subset of newly enrolling participants in the parent ASPREE study.

Prior to enrollment in the ASPREE parent study, those considered likely to be suitable attend a screening visit where baseline examination and testing is organised and run-in medication (placebo) is prescribed. One month later, if entry testing and compliance with run-in medication has been satisfactory (and the GP has authorised participation) each participant is randomised and enters the ASPREE parent study.

All ASPREE participants are contacted three-monthly by phone in order to maintain compliance.
Intervention code [1] 287427 0
Prevention
Comparator / control treatment
The constituents of the placebo tablets are: calcium hydrogen phosphate dehydrate, cellulose (microcrystalline), citric acid anhydrous, lactose monohydrate, magnesium stearate, maize starch and silica (colloidal anhydrous).
Control group
Placebo

Outcomes
Primary outcome [1] 289896 0
Change in knee cartilage volume, measured from MR images.
Timepoint [1] 289896 0
3 years.
Secondary outcome [1] 303504 0
Knee symptoms (knee pain, stiffness and function and total) will be assessed using the WOMAC (the Western Ontario and McMaster Universities Osteoarthritis Index.
Timepoint [1] 303504 0
3 years,
Secondary outcome [2] 303505 0
Gait speed: time taken in seconds to walk 3 meters at their usual walking pace from a standing start
Timepoint [2] 303505 0
3 years
Secondary outcome [3] 303506 0
Steps per day: using a pedometer (G-Sensor GS 2025) worn for 7 days at the waist.
Timepoint [3] 303506 0
3 years
Secondary outcome [4] 303507 0
Physical Activity: using the Physical Activity Scale in the Elderly questionnaire.
Timepoint [4] 303507 0
3 years

Eligibility
Key inclusion criteria
Randomised ASPREE participants in Melbourne (Age >=70 years, free of previous cardiovascular disease or stroke, have preserved intellectual function and have no known life-limiting illness)
Aged 70 and over
Able and willing to provide informed consent
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) As for ASPREE (Cardiovascular disease, impaired intellectual function, life limiting illness);
2) People with planned or prior knee joint replacement surgery of the dominant knee; unable to walk independently (no stick or frame).
3) People with rheumatoid arthritis, other inflammatory arthritis, or significant knee injury;
4) People undergoing arthroscopy or open surgery in the index knee in the last 12 months;
5) People receiving intra-articular therapy in the index knee in the last 12 months;
6) Any contraindication to MRI scanning (e.g. implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, or claustrophobia).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment into the parent study ASPREE is through general practitioner co-investigators. Informed consent for participation in ASPREE is obtained by ASPREE research staff. Enrollment into the ASPREE-KNEE Sub-study takes place after the second baseline ASPREE visit, after randomisation to either aspirin or placebo in ASPREE.

Randomisation takes place through the parent ASPREE study. All staff remain blinded to treatment allocation through the randomisation procedure.

The randomisation list is generated by an independent statistician using the STATA "ralloc" procedure with randomisation stratified for site and age (<80 yrs and >80 yrs).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list is generated by an independent statistician using the STATA "ralloc" procedure with randomisation stratified for site and age (<80 yrs and >80 yrs).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
24/06/2013
Actual
24/06/2013
Date of last participant enrolment
Anticipated
Actual
25/11/2013
Date of last data collection
Anticipated
Actual
30/01/2017
Sample size
Target
630
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287529 0
University
Name [1] 287529 0
Monash University
Country [1] 287529 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton,
Victoria, 3800
Country
Australia
Secondary sponsor category [1] 286280 0
None
Name [1] 286280 0
Address [1] 286280 0
Country [1] 286280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289511 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 289511 0
Ethics committee country [1] 289511 0
Australia
Date submitted for ethics approval [1] 289511 0
Approval date [1] 289511 0
11/06/2013
Ethics approval number [1] 289511 0
CF13/1714 - 2013000889

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41118 0
A/Prof Anita Wluka
Address 41118 0
Department of Epidemiology & Preventive Medicine School of Public Health & Preventive Medicine,
Monash University
The Alfred Centre, Alfred Hospital,
Commercial Road
Melbourne VIC 3004
Country 41118 0
Australia
Phone 41118 0
+61 3 9903 0994
Fax 41118 0
Email 41118 0
[email protected]
Contact person for public queries
Name 41119 0
Anita Wluka
Address 41119 0
Department of Epidemiology & Preventive Medicine School of Public Health & Preventive Medicine,
Monash University
The Alfred Centre, Alfred Hospital,
Commercial Road
Melbourne VIC 3004
Country 41119 0
Australia
Phone 41119 0
+61 3 9903 0994
Fax 41119 0
Email 41119 0
[email protected]
Contact person for scientific queries
Name 41120 0
Anita Wluka
Address 41120 0
Department of Epidemiology & Preventive Medicine School of Public Health & Preventive Medicine,
Monash University
The Alfred Centre, Alfred Hospital,
Commercial Road
Melbourne VIC 3004
Country 41120 0
Australia
Phone 41120 0
+61 3 9903 0994
Fax 41120 0
Email 41120 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a substudy of a larger study. Participants did not consent to sharing of their data related to this study to anyone other than study personnel.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.