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临床试验/NCT04241211
NCT04241211Unknown4 期

Comparative Study for Incidence of Proximal Junctional Kyphosis Between Parathyroid Hormone and Denosumab Following Adult Spinal Deformity Surgery : A Prospective, Randomized Controlled Trial

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Denosumab Prefilled Syringe [Prolia] (Drug)

TP group

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ho-Joong Kim

professor

Seoul National University Bundang Hospital

研究点 (1)

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