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临床试验/NCT01310465
NCT01310465Unknown4 期

The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion

Fudan University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
50
试验地点
1

研究概览

简要总结

Many patients who have lumbar degenerative disease suffer from osteoporosis or reduced bone mass or low bone mineral density. Among patients with lumbar degenerative disease, some need fusion surgery. But conditions of osteoporosis or low bone mineral density slow down the rate of bone fusion, reduce the success of bone fusion, and ultimately affect the overall effectiveness of surgery. Zoledronic acid is an effective anti-osteoporotic. Many researchers dispute if zoledronic acid can promote the healing of long bone fractures. But few researchers focus on the effect of zoledronic acid to lumbar fusion. In this study, we select patients with lumbar degenerative disease who have had lumbar interbody fusion surgery. Three days postoperatively, the patients were randomized to either one infusion of zoledronic acid or sodium chloride intravenously. We follow all these patients for 6 months. During this time, we detect bone metabolism and bone fusion of these patients. At last, we can tell if zoledronic acid can modify bone metabolism and promote bone fusion.

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
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with lumbar degenerative disease who have had lumbar interbody fusion surgery
  • Age 50-70 years old
  • Willing to sign informed consent

排除标准

  • Application of strontium ranelate, sodium fluoride or parathyroid hormone
  • Application of bisphosphonates more than 8 weeks during 2 years preoperatively
  • Suffering from bone fracture during 3 months preoperatively
  • Urinary creatinine clearance rate less than 35mL/min
  • Serum calcium concentrations greater than 2.75mmol/L or less than 2.00mmol/L
  • Pregnancy or breast-feeding women
  • Suffering from cancer or other diseases that may be expected to live less than a year

研究组 & 干预措施

Experimental group

Experimental

Three days postoperatively, patients in this group are given one infusion of zoledronic acid intravenously.

干预措施: zoledronic acid (Drug)

Placebo Comparator

Placebo Comparator

Three days postoperatively, patients in this group are given one infusion of sodium chloride intravenously.

干预措施: sodium chloride (Drug)

研究者

申办方类型
Other

研究点 (1)

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