Phase 2 Study of the Efficacy of Zoledronic Acid in Low Back Pain Related to Vertebral Endplate Signal Changes, the So-called Modic Changes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Low back pain (VAS)
研究概览
简要总结
Modic changes are associated with low back pain (LBP) both in clinical and general population-based samples. Type I changes are regarded as more likely to be painful than type II changes. Several studies suggest that type I changes are inflammatory in nature.
详细描述
So far, no treatment exists for LBP due to Modic changes. Bisphosphonates could be effective in this specific low back disorder through two mechanisms: 1) they could consolidate vertebral bodies thereby improving the tolerance for mechanical load and 2) they could diminish inflammation as observed recently in case of ibandronate in an experimental model.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years old
- •low back pain for more than 3 months
- •Modic type I or II change in lumbar magnetic resonance imaging
- •Intensity of low back pain at least 6 on 10-cm VAS or Oswestry disability score at least 30%
排除标准
- •premenopausal female patients with possibility of pregnancy
- •patients with calculated creatinine clearance of less than 40 ml/min
- •patients with hypocalcemia
- •patients with known hypersensitivity to zoledronic acid or other bisphosphonates or ingredients of the infusional product
- •patients with red flags symptoms
- •patients with nerve root impingement
- •patients with willingness for early retirement
研究组 & 干预措施
Zoledronic acid
Single infusion of 5 mg zoledronic acid I.V.
干预措施: Zoledronic acid vs. placebo (Drug)
Placebo
Single infusion of 100 ml isotonic NaCl-solution I.V.
干预措施: Zoledronic acid vs. placebo (Drug)
结局指标
主要结局
Low back pain (VAS)
时间窗: 0, 1, 12 months
次要结局
- Sick leaves(0, 12 months)
- Health-related quality of life (RAND-36)(0, 1, 12 months)
- Radiologic phenotype(0, 12 months)
- Flexibility of the lumbar spine(0, 1, 12 months)
- Disability (Oswestry)(0, 1, 12 months)
研究者
Katri Koivisto
Specialist in Physical and Rehabilitation Medicine
University of Oulu