Denosumab vs Zoledronate Efficacy in Osteopenic Patients With Lumbar Degenerative Disease After Lumbar Fusion Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) back
研究概览
简要总结
The aim of the study was to compare denosumab and zoledronate efficacy in bone mass, bone turnover markers (BTMs), Visual Analogue Scale (VAS) for leg and back, EuroQol Five-Dimension (EQ-5D) scores, Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31) scores, and Roland-Morris Disability Functioning Questionnaire (RMDQ) scores, secondary fracture, complications and adverse events after lumbar fusion.
详细描述
Lumbar degenerative disease including spinal stenosis and lumbar spondylolisthesis were the most common reason lead to older patients disability, which was the main indication for older patients to perform lumbar fusion surgery. For patients with lumbar degenerative disease older than 50 years old, a proportion of patients had osteoporosis. The trial aims to investigate whether denosumab versus zoledronate acid in osteopenic patients with lumbar fusion surgery.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 40 to 85 years
- •who diagnosed with lumbar spinal stenosis or lumbar spondylolisthesis
- •osteopenia with BMD T score between -1 and -2.5 via dual energy X-ray
- •low back pain or leg numbness or weakness
- •MRI demonstrated signs of nerve compression
- •patients with one or two level symptoms.
排除标准
- •cauda equina syndrome
- •progressive neurologic deficit
- •history of cancer
- •scoliosis greater than 15°
- •back open surgery history
- •have contraindications for surgery
- •who had anti-osteoporosis medication within 6 weeks
研究组 & 干预措施
Denosumab
denosumab (60 mg subcutaneously, per 6 month)
干预措施: Denosumab 60 mg/ml [Prolia] (Drug)
zoledronate
zoledronate (5mg, intravenous infusion once a year)
干预措施: Zoledronate (Drug)
结局指标
主要结局
Visual analog scale (VAS) back
时间窗: up to 12 months
The VAS score for back pain were determined at baseline, 6 and 12 month. Use a ruler about 10cm long, one side is marked with "0" and the other "10" respectively. A score of 0 indicates no pain, 10 indicates the most unbearable pain.
Procollagen type 1 n-terminal propeptide (P1NP)
时间窗: up to 12 months
Bone formation marker, P1NP were determined at baseline, 6 and 12 months after surgery
Total hip BMD
时间窗: up to 12 months
Total hip BMD were determined at baseline, 6 and 12 months via dual-energy X-ray
Femoral neck BMD
时间窗: up to 12 months
Femoral neck BMD were determined at baseline, 6 and 12 month via dual-energy X-ray
C-terminal cross-linked type 1 collagen terminal peptide (CTX)
时间窗: up to 12 months
Bone resorption marker, CTX were determined at baseline, 6 and 12 months after surgery
Lumbar bone mineral density(BMD)
时间窗: up to 12 months
Lumbar vertebral (L1 to L4, except the surgery segment) BMD were determined at baseline, 6 and 12 months via dual energy X-ray
次要结局
- Complications(up to 12 month)
- The Roland-Morris Disability Questionnaire(up to 12 month)
- New fracture rate(up to 12 month)
- The QUALEFFO-31 Questionnaire(up to 12 month)
- Adverse events(up to 12 month)
- The EQ-5D Questionnaire(up to 12 month)