NCT05559268尚未招募4 期
Single Dose Subcutaneous Injections of Denosumab for Patients Underwent Cemented Total Knee Arthroplasty. A Randomized Controlled Study on the Effects on Bone Microarchitecture, Skeletal Muscle, Cartilage and Synovium
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Bone turnover markers
研究概览
简要总结
This study evaluates single dose of Denosumab in decreasing systemic and periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within 2 months after surgery. This study also evaluates the anti-RANKL effect of single dose of Denosumab in serum, skeletal muscle, synovium, fat, and cartilage.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Bilateral Knee Osteoarthritis treated with Staged Bilateral Total Knee Arthroplasty, with an Interval of 8 weeks
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 Patients failed to finish contralateral Total Knee Arthroplasty at 8 weeks
研究组 & 干预措施
Denosumab
Experimental
干预措施: Denosumab 60 MG/ML Injectable Solution [Prolia] (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Bone turnover markers
时间窗: 8 weeks
βCTXI, NTXI, 25(OH)VD3, CT, BGP, PINP
Bone Microarchitecture
时间窗: 8 weeks
Bone Microarchitecture on microCT
次要结局
- intermuscular and intramuscular adipose(8 weeks)
- Mankin Histological-Histochemical Grading of Cartilage(8 weeks)
- Histopathological grading of synovium(8 weeks)
研究者
Xiang Shuai, MD
Dr.
The Affiliated Hospital of Qingdao University
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