Does statin use have a disease modifying effect in symptomatic knee osteoarthritis? A multicentre randomised, double-blind, placebo-controlled trial

Does statin use reduce the rate of knee cartilage volume loss in symptomatic knee osteoarthritis? A multicentre randomised, double-blind, placebo-controlled trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000190707

Acronym

OAKS Study

Enrollment

308

Registered

2013-02-18

Start date

2013-08-26

Completion date

2016-02-04

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

40 mg of atorvastatin (oral tablet) once daily over 2 years

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Healthy volunteers

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.

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).

Outcome results