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

Phase 3

Completed

• Conditions: knee osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12613000190707
• Lead Sponsor: Yuanyuan Wang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-18
• Study Completion: 2018-05-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 308

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annual change in tibial cartilage volume, assessed from knee MRI[2 years after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Progression of cartilage defects, assessed from knee MRI[2 years after intervention commencement];Progression of bone marrow lesions, assessed from knee MRI[2 years after intervention commencement];Change in knee symptoms and function, assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)[2 years after intervention commencement]