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临床试验/NCT00765687
NCT00765687已完成4 期

A Multi-center Observational Clinical Study of Screening of Non-small-cell Lung Cancer With Bone Metastasis and Efficacy and Safety of Those Receiving Bisphosphonates

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 432 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
432
试验地点
1
主要终点
Skeleton-related event

研究概览

简要总结

A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Age >18, either sex
  • Histologically confirmed non-small cell cancer
  • One bone metastasis at least confirmed by image(X ray,CT or others)
  • Without receiving zoledronic acid
  • Life expectancy > 6 M

排除标准

  • Women who are pregnant or in lactation
  • Patients with hyperostosis
  • with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
  • Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
  • Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

研究组 & 干预措施

Observation

No Intervention

干预措施: bisphosphates (Drug)

结局指标

主要结局

Skeleton-related event

时间窗: 24 months

次要结局

  • overall survival(24 months)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Zhang

Profressor

Sun Yat-sen University

研究点 (1)

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