Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- PJK
研究概览
简要总结
Medical therapy that can lower PJK rates are also being sought. Teriparatide (TP), a recombinant human parathyroid hormone (PTH 1-34), is a bone forming agent mainly used to treat osteoporotic patients with high risk of osteoporotic fracture. There has been reports suggesting protective effect of prophylactic TP to osteoporotic patients receiving ASD surgery concerning PJK.6 Although it had limitations of small sample size and surgical selection bias owing to study design being retrospective. We hypothesized prophylactic TP would act as to reduce the incidence of PJK and therefore reduce PJF and necessity of revision surgeries in patients after ASD correction surgery. Our study can consolidate the beneficial effect of prophylactic TP to patients receiving ASD surgery by reducing the incidence of PJK.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients between 50 years to 80 years of age with ASD
- •Multilevel instrumented fusion
- •Cobb angle above 25̊ in coronal plane deformities, Lumbar lordosis below 20̊ in sagittal plane deformities
- •Minimum follow-up of 1 years
排除标准
- •Diagnosis being tumor or infectious condition like Tb spondylitis were excluded
- •Patients with adverse reactions or contraindications to TP were excluded; side effects to TP or bone cancer or metastasis
研究组 & 干预措施
Control group
干预措施: Denosumab Prefilled Syringe [Prolia] (Drug)
TP group
干预措施: Forsteo (Drug)
结局指标
主要结局
PJK
时间窗: 15months
PJK prevalance
次要结局
未报告次要终点
研究者
Ho-Joong Kim
professor
Seoul National University Bundang Hospital
