JPRN-UMIN000015202招募中未知
Clinical investigation to examine the effect of bone formation of PTH on multilevel spinal implant surgery for vertebral degenerative disease associated with osteoporosis
1.University of Yamanashi2.Hamamatsu University School of Medicine3.Shinshu University, School of Medicine1-3Department of Orthopaedic Surgery0 个研究点目标入组 160 人开始时间: 2014年9月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 50years-old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients who are eligilble for multilevel spinal fusion surgery for having lumbar degenerative disease (lumbar degenerative spondylolisthesis, adult spinal deformity, spinal stenosis, spondylolytic
- •spondylolisthesis)
- •2. Patients 50 years of age or older at the time of signing consent form
- •3. Patients with osteoporosis at a high risk of fracture
排除标准
- •1.The following patients are considered to be at high risk of developing osteosarcoma
- •(1)Patients with Paget's disease in the bone
- •(2)Patients with high alkaline phosphatase of unknown cause
- •(3)Patients with a history of radiotherapy which is likely to have affected the bone
- •2.Patients with hypercalcaemia(adjusted serum calcium level>=10.5mg/dL)
- •3.Patients with primary malignant osteosarcoma or metastatic bone tumor
- •4.Patients with metabolic bone diseases other than osteoporosis (hyperparathyroidism etc.).
- •5.Patients with a history of hypersensitivity to the constituents of teriparatide from subcutaneous injection.
- •6. Females who are pregnant or may be pregnant.
- •7.Patients with contraindication to bisphosphonate treatments.
- •8.Patients with a history of administration of denosumab or Forteo use.
- •9. Any other patients whom the attending physician investigator has determined to be unsuitable for the conduct of the study.
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