The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Change in Bone Mass index
研究概览
简要总结
This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.
详细描述
Periprosthetic bone resorption after Total Knee Arthroplasty occurs as a consequence of prosthetic implant on the bone. Some of this patients (up to 13%) develop an aseptic failure of the prosthesis needing revision surgery.
2 groups of patients are treated with Placebo and Denosumab in a double blind prospective trial. Densitometry, Knee society score (KSS), Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) were done in both groups at 0,3,6 and 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty
排除标准
- •Patients allergies to Denosumab
- •Patients with previous Osteoporosis treatment
- •Patients with renal failure
- •Patients with previous Bisphosphonate treatment for more than 5 years
研究组 & 干预措施
Denosumab
Patients treated with Denosumab
干预措施: Denosumab (Drug)
Placebo
Patients treated with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Bone Mass index
时间窗: Change in densitometry before surgery (0) and at twelve (12) months after surgery
Bone Mass index in gr/cm3
次要结局
- Quality of life (SF-36)(SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery)
- Liver function(Before surgery and at three, six and twelve months after surgery)
- Quality of Life (WOMAC)(WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery)
- Kidney function(Before surgery and at three, six and twelve months after surgery)
- Bone turnover markers(At three, six and twelve months after surgery)