None listed
Conditions
Brief summary
Knee osteoarthritis (OA) is a major public health problem. It develops over many years, with progressive loss of articular cartilage. In people over 70, even without radiographic OA, most will have cartilage damage. Loss of cartilage is associated with pain and reduced function. Thus in an older population, it is important to reduce knee cartilage loss, and prevent structural progression. Low dose aspirin, used in the prevention of cardiovascular disease, may also affect cartilage by a variety of mechanisms. We have pilot data in 2 independent studies suggesting that low dose aspirin may reduce cartilage loss by more than 50%. The ASPirin in Reducing Events in the Elderly (ASPREE, ClinicalTrials.gov identifier NCT01038583, website www.aspree.org) study is a current 5 year randomised placebo controlled trial testing whether low dose aspirin in healthy adults > 70 years prevents cardiovascular disease, cancer and functional decline. Within this larger study (ASPREE parent study) we will examine in the ASPREE Knee Sub-study whether the use of low dose aspirin reduces change in knee cartilage volume in older adults.
Interventions
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 i
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.
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
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
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).
Outcome results
None listed