The Effect of Alendronate Sodium Vitamin D3 Tablets on Knee Joint Structure and Knee Osteoarthritis Pain: A Multi-center, Randomized, Double-blind, Controlled Study.
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- WORMS score of knee joint MRI
研究概览
简要总结
The purpose of this study is to evaluate the effect of alendronate sodium vitamin D3 tablets compared with placebo on the improvement of joint structure and joint pain in participants with knee osteoarthritis. The treatment period of this study is one year and followed-up period is 2 years. The results of knee joint MRI will be evaluated by using the WORMS score.
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled study This study is planned to commence after obtaining Ethics Committee approval. participants will be randomised to a one-year course of alendronate sodium vitamin D3 tablets or placebo. 1:1 double blinded randomisation will be undertaken. This study plans to enroll 60 participants and will be carried out in three domestic centers (Peking Union Medical College Hospital, Zhongshan Hospital and The Third Affiliated Hospital of Southern Medical University) with a follow-up period of 2 years.
As the main goal of this exploratory study is to evaluate the effect of alendronate sodium vitamin D3 tablets compared with placebo on the improvement of joint structure and joint pain in participants with knee osteoarthritis. The primary outcome measure is WORMS score of knee joint MRI at 6 months and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with significant knee pain (pain score≥40mm on the 100mmVAS scale);
- •Male or female patients, between 50-75 years old;
- •MRI suggests bone marrow edema-like lesions;
- •Knee osteoarthritis (in accordance with the diagnostic criteria of American College of Rheumatology (ACR) and Chinese Orthopaedic Association);
- •Kellgren-Lawrence gradingⅠorⅡin X-ray;
排除标准
- •Other forms of active arthritis (such as rheumatoid arthritis or other inflammatory arthritis);
- •Taken non-steroidal anti-inflammatory drugs and central analgesics (such as opioids) within two weeks；
- •Liver function ALT or AST is 1.5 times the upper limit of normal； creatinine clearance <35ml/min；
- •Pregnancy or suckling;
- •Serious heart disease, endocrine, digestive, mental, nervous system diseases or cancer;
- •Active ulcers and a history of upper gastrointestinal bleeding;
- •Esophageal motility disorders, such as esophageal tardiness or stenosis;
- •Renal dysfunction or osteomalacia;
- •Tobacco addiction (mean 10 cigarettes per day or more) or/and alcohol addiction (mean 50ml per day or more);
- •Fresh fracture in the last six months;
- •Serious illnesses and life expectancy<2 years;
- •Allergic to study drugs;
- •Used any study drug or device within 30 days before randomization or within the drug half-life (whichever is longer);
- •Failure to take medication as required;
- •Replacement surgery in the near future;
- •Contraindications to MRI scans (e.g. implanted pacemakers, metal sutures, shrapnel or iron filings in the eyes, claustrophobia, knees too large to use coils);
- •Sensitive to or unsuitable for X-ray exposure (e.g. aplastic anemia, etc);
- •Poor dental health or dental surgery in the near future.
研究组 & 干预措施
alendronate sodium vitamin D3 tablets
participants will receive alendronate sodium vitamin D3 tablets once per week for one year.
干预措施: alendronate sodium vitamin D3 tablets (Drug)
placebo
participants will receive a placebo tablet once per week for one year.
干预措施: Placebo (Drug)
结局指标
主要结局
WORMS score of knee joint MRI
时间窗: The 12th month
WORM score of participants at the 12th month after enrollment
次要结局
- bone density (lumbar spine, hip joint and knee joint)(The 24th month)
- WORMS score of knee joint MRI(The 24th month)
- Quality of life (the MOS item short from health survey,SF-36 )(The 12th month)
- Pain intensity and symptom record(The 12th week)
- Risk of knee replacement(The 24th month)
- Kellgren & Lawrence(KL) grading Score(The 24th month)
- Serum IL-6, TNF-a, erythrocyte sedimentation rate, C-reactive protein(The 12th month)