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临床试验/NCT05203588
NCT05203588Unknown4 期

The Effects of Denosumab on Bone Fusion and Bone Metabolism in Osteoporotic Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion

Shanghai Changzheng Hospital1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年10月9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
116
试验地点
1
主要终点
lumbar fusion rate

研究概览

简要总结

Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a concomitant increase in prevalence of osteoporosis which is a detrimental factor for Lumbar fusion and instrumentation. Osteoporosis-related bone fragility is a primary reason for spinal fusion failure, implant fixation failure, and vertebral compression fractures above or below the fusion sites.

Denosumab is a human monoclonal antibody against RANKL, it inhibits osteoclast mediated bone destruction and has been found to be effective in treating osteoporosis, including reducing bone turnover markers, increasing bone mineral density (BMD), and reducing fractures. But few studies focus on the effects of Denosumab on lumbar fusion. In this study, we include osteoporotic patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. The patients were randomized to either treatment of Denosumab or no treatment. All these patients are followed at 3, 6, 9, 12 months postoperation. During these periods, we detect bone metabolism and bone fusion of these patients. Finally, we would report whether Denosumab can improve bone metabolism and promote bone fusion or not.

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
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of degenerative lumbar diseases with symptoms of low-back pain and/or leg pain for at least 3 months, which was not be adequately controlled by nonoperative treatments.
  • Diagnosis of osteoporosis, defined as a bone mineral density (BMD) at lumbar or femoral neck with 2.5 standard deviations or more below the mean peak bone mass (T scores <-2.5 SD) measured by dual-energy X-ray absorptiometry (DXA).
  • Patients will be underwent single-level or two-level lumbar interbody fusion.

排除标准

  • Paget disease of bone,
  • Low laboratory tests for calcium,
  • Previous radiation treatment or fusion surgery to lumbar spine,
  • Bone tumors,
  • Bone infection,
  • Acute vertebral fractures
  • Severe spinal deformities such as degenerative scoliosis,
  • Other metabolic bone disease,
  • History of a anti-osteoporosis medication
  • Combined with severe morbidities,
  • Uncorrected bleeding diatheses
  • Application of steroids.

研究组 & 干预措施

Experimental group

Experimental

Patients in this group are received denosumab (60 mg) subcutaneously at one week and 26 weeks after the lumbar fusion surgery, combined with receiving daily calcium (≥1·0 g) and vitamin D (≥400 IU).

干预措施: Denosumab 60 mg/ml Injectable Solution [Prolia] (Drug)

Experimental group

Experimental

Patients in this group are received denosumab (60 mg) subcutaneously at one week and 26 weeks after the lumbar fusion surgery, combined with receiving daily calcium (≥1·0 g) and vitamin D (≥400 IU).

干预措施: calcium and vitamin D (Drug)

Control group

Sham Comparator

Patients in this group are only received daily calcium (≥1·0 g) and vitamin D (≥400 IU) after the lumbar fusion surgery.

干预措施: calcium and vitamin D (Drug)

结局指标

主要结局

lumbar fusion rate

时间窗: 12-month post-operation

Fusion rate assessed by CT scan and dynamic radiograph

次要结局

  • Bone metabolic markers including serum carboxy terminal cross-linked telopeptide of type I collagen (β-CTX) and osteocalcin (OCN)(12-month post-operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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