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临床试验/NCT00219271
NCT00219271已完成4 期

Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2003年9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
入组人数
60
试验地点
1
主要终点
To assess the activity of one year treatment with zoledronic acid

研究概览

简要总结

The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Zoledronic acid

Experimental

4 mg IV infused over 15 minutes every 3 months

干预措施: Zoledronic acid (Drug)

结局指标

主要结局

To assess the activity of one year treatment with zoledronic acid

时间窗: 12 mos

次要结局

  • Three-year disease free survival(3 years)
  • Change in bone mineral density at 12, 24 and 36 months versus baseline(12, 24 and 36 months)
  • Changes in bone resorption markers at 12, 24 and 36 months versus baseline(12, 24 and 36 months)
  • Safety and tolerability through abnormal values and AE reporting(upto 36 mos)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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