The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Medial tibio-femoral joint space narrowing (mm)
研究概览
简要总结
The primary aim of this study is to determine if the dietary supplements, glucosamine sulphate and/or chondroitin can limit or reduce structural disease progression whilst providing symptomatic benefit in people with osteoarthritis (OA) of the knee.
The specific hypotheses to be tested in the proposed double blind, placebo-controlled, randomised clinical trial are that, compared to participants allocated to placebo, participants allocated to either or both of these dietary supplements will demonstrate:
- reduced medial tibio-femoral joint space narrowing at 2 years AND;
- reduced knee pain over 1 year
These benefits will be achieved by participants allocated to glucosamine sulphate and/or chondroitin (the study treatments) without concomitant:
- increased use of analgesics
- reduced health-related quality of life
- reduced participation in leisure-time physical activity
详细描述
The LEGS study is a double blind, placebo-controlled randomised clinical trial using a 2 x 2 factorial design. Participant will be randomly allocated to one of the four possible treatment combinations:
- Glucosamine and Chondroitin (double active)
- Placebo Glucosamine and Chondroitin
- Glucosamine and Placebo Chondroitin
- Placebo Glucosamine and Placebo Chondroitin (double placebo)
Each allocation involves taking 4 study treatment capsules once a day for two years.
A total of 600 participants with symptomatic knee OA will be recruited by general media advertising and by General Practitioners through the New South Wales Divisions of general practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Knee pain, or taking NSAIDs/ analgesia for knee pain on most days past month
- •Knee pain 4-10 on 10cm VAS
- •Medial tibio-femoral compartment joint space narrowing in symptomatic knee
排除标准
- •Unstable diabetes
- •<2mm medial tibio-femoral compartment joint space width
研究组 & 干预措施
1
Glucosamine sulfate 1500mg and chondroitin sulfate 800mg (low molecular weight, bovine)
干预措施: Glucosamine sulphate and chondroitin (Dietary Supplement)
4
Matching glucosamine/chondroitin placebo capsules
干预措施: Placebo capsules for glucosamine and chondroitin (Dietary Supplement)
3
Chondroitin sulfate 800mg
干预措施: Chondroitin sulphate (Dietary Supplement)
2
Glucosamine sulfate 1500mg
干预措施: Glucosamine sulphate (Dietary Supplement)
结局指标
主要结局
Medial tibio-femoral joint space narrowing (mm)
时间窗: MRI (1 year) Radiographs (2 years)
Knee pain (11 point Likert scale)
时间窗: Bimonthly for 1 year
次要结局
- WOMAC(1 year, 2 years)
- Patients global assessment(Bimonthly for 1 year)
- Total NSAIDs use(Bimonthly for 1 year)
- General health status (SF-12v2)(1 year, 2 years)
- Cost-effectiveness (cost per OMERACT-OARSI responder)(2 years)
- Leisure time physical activity(1 year, 2 years)