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Trial registered on ANZCTR


Registration number
ACTRN12613000190707
Ethics application status
Approved
Date submitted
15/02/2013
Date registered
18/02/2013
Date last updated
18/01/2019
Date data sharing statement initially provided
18/01/2019
Date results information initially provided
18/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does statin use have a disease modifying effect in symptomatic knee osteoarthritis? A multicentre randomised, double-blind, placebo-controlled trial
Scientific title
Does statin use reduce the rate of knee cartilage volume loss in symptomatic knee osteoarthritis? A multicentre randomised, double-blind, placebo-controlled trial
Secondary ID [1] 281966 0
Nil
Universal Trial Number (UTN)
Trial acronym
OAKS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 288389 0
Condition category
Condition code
Musculoskeletal 288736 288736 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40 mg of atorvastatin (oral tablet) once daily over 2 years
Intervention code [1] 286531 0
Treatment: Drugs
Comparator / control treatment
40 mg of placebo (with no active ingredients) once daily over 2 years
Control group
Placebo

Outcomes
Primary outcome [1] 288878 0
Annual change in tibial cartilage volume, assessed from knee MRI
Timepoint [1] 288878 0
2 years after intervention commencement
Secondary outcome [1] 301223 0
Progression of cartilage defects, assessed from knee MRI
Timepoint [1] 301223 0
2 years after intervention commencement
Secondary outcome [2] 301224 0
Progression of bone marrow lesions, assessed from knee MRI
Timepoint [2] 301224 0
2 years after intervention commencement
Secondary outcome [3] 301225 0
Change in knee symptoms and function, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [3] 301225 0
2 years after intervention commencement

Eligibility
Key inclusion criteria
1. Males and females with symptomatic knee osteoarthritis for at least 6 months with a pain score at least 20 mm on a 100 mm visual analogue scale;
2. Age 40-70 years old;
3. Meet the America College of Rheumatology criteria for symptomatic knee osteoarthritis.
Minimum age
40 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability to give informed consent;
2) Patients with severe radiographic knee osteoarthritis (grade 3 according to Altman’s atlas) or severe knee pain (on standing > 80 mm on a 100 mm visual analogue scale);
3) Patients with rheumatoid arthritis, other inflammatory arthritis, or significant knee injury;
4) Patients in whom statins are indicated for familial hypercholesterolaemia, cardiovascular disease, diabetes, taking current lipid-lowering therapy, or with previous adverse reaction to statins;
5) Patients with absolute cardiovascular risk assessed using the Framingham Risk Equation of more than 15% within the next 5 years (National Heart Foundation of Australia, 2005);
6) Patients with clinically significant renal disease or aspartate aminotransferase, alanine aminotransferase, or creatine kinase more than twice the upper limit of laboratory normal range;
7) Patients undergoing arthroscopy or open surgery in the index knee in the last 12 months;
8) Patients receiving intra-articular therapy in the index knee in the last 12 months;
9) Concomitant use of potent analgesics including opiates;
10) Co-morbidity that may limit participation (e.g. planned index knee joint replacement, medical conditions e.g. malignancy in the past 5 years other than non-melanoma skin cancer) or relocation;
11) 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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation is done based on computer generated random numbers prepared by a statistician with no involvement in the trial. Block randomisation is performed, stratified according to the study sites.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 286741 0
Government body
Name [1] 286741 0
National Health and Medical Research Council (NHMRC)
Address [1] 286741 0
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 286741 0
Australia
Primary sponsor type
Individual
Name
Yuanyuan Wang
Address
Department of Epidemiology & Preventive Medicine
Monash University
Level 1, 553 St Kilda Road
Melbourne VIC 3004
Australia
Country
Australia
Secondary sponsor category [1] 285519 0
Individual
Name [1] 285519 0
Flavia Cicuttini
Address [1] 285519 0
Department of Epidemiology & Preventive Medicine
Monash University
Level 1, 553 St Kilda Road
Melbourne VIC 3004
Australia
Country [1] 285519 0
Australia
Secondary sponsor category [2] 285520 0
Individual
Name [2] 285520 0
Andrew Tonkin
Address [2] 285520 0
Department of Epidemiology & Preventive Medicine
Monash University
553 St Kilda Road
Melbourne VIC 3004
Australia
Country [2] 285520 0
Australia
Secondary sponsor category [3] 285521 0
Individual
Name [3] 285521 0
Graeme Jones
Address [3] 285521 0
Private Bag 23, Menzies Research Institute
Hobart TAS 7000
Australia
Country [3] 285521 0
Australia
Secondary sponsor category [4] 285522 0
Individual
Name [4] 285522 0
Catherine Hill
Address [4] 285522 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Australia
Country [4] 285522 0
Australia
Secondary sponsor category [5] 285523 0
Individual
Name [5] 285523 0
Changhai Ding
Address [5] 285523 0
Private Bag 23, Menzies Research Institute
Hobart TAS 7000
Australia
Country [5] 285523 0
Australia
Secondary sponsor category [6] 285524 0
Individual
Name [6] 285524 0
Anita Wluka
Address [6] 285524 0
Department of Epidemiology & Preventive Medicine
Monash University
Level 1, 553 St Kilda Road
Melbourne VIC 3004
Australia
Country [6] 285524 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288815 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 288815 0
Ethics & Research Governance
Level 5, 553 St Kilda Road
Melbourne, VIC 3004
Australia
Ethics committee country [1] 288815 0
Australia
Date submitted for ethics approval [1] 288815 0
19/11/2012
Approval date [1] 288815 0
05/02/2013
Ethics approval number [1] 288815 0
521/12
Ethics committee name [2] 292619 0
Tasmania Health & Medical Human Research Ethics Committee
Ethics committee address [2] 292619 0
Building 1
301 Sandy Bay Road, Sandy Bay
Hobart, TAS 7001
Ethics committee country [2] 292619 0
Australia
Date submitted for ethics approval [2] 292619 0
Approval date [2] 292619 0
07/02/2013
Ethics approval number [2] 292619 0
H0012971
Ethics committee name [3] 292620 0
Human Research Ethics Committtee (TQEH/LMH/MH)
Ethics committee address [3] 292620 0
Basil Hetzel Institute DX465101
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [3] 292620 0
Australia
Date submitted for ethics approval [3] 292620 0
Approval date [3] 292620 0
22/01/2014
Ethics approval number [3] 292620 0
HREC/13/TQEHLMH/20

Summary
Brief summary
The aim of this randomised controlled trial is to determine whether statins slow the progression of knee osteoarthritis. The hypothesis is that atorvastatin use will reduce the rate of knee cartilage volume loss over 2 years compared with placebo in people with symptomatic knee osteoarthritis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37902 0
Dr Yuanyuan Wang
Address 37902 0
Department of Epidemiology & Preventive Medicine
Monash University
Level 1, 553 St Kilda Road
Melbourne VIC 3004
Australia
Country 37902 0
Australia
Phone 37902 0
+61 3 99030353
Fax 37902 0
Email 37902 0
yuanyuan.wang@monash.edu
Contact person for public queries
Name 37903 0
Prof Flavia Cicuttini
Address 37903 0
Department of Epidemiology & Preventive Medicine
Monash University
Level 1, 553 St Kilda Road
Melbourne VIC 3004
Australia
Country 37903 0
Australia
Phone 37903 0
+61 3 99030158
Fax 37903 0
Email 37903 0
flavia.cicuttini@monash.edu
Contact person for scientific queries
Name 37904 0
Prof Flavia Cicuttini
Address 37904 0
Department of Epidemiology & Preventive Medicine
Monash University
Level 1, 553 St Kilda Road
Melbourne VIC 3004
Australia
Country 37904 0
Australia
Phone 37904 0
+61 3 99030158
Fax 37904 0
Email 37904 0
flavia.cicuttini@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary