NCT00172055已完成3 期
Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy.
研究概览
简要总结
The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All stages of prostate cancer without bone metastases
- •No evidence of severe osteoporosis
- •ECOG performance status 0, 1 or 2
排除标准
- •Surgery / fracture at the lumbosacral spine, bilateral hip implants
- •Evidence of metabolic bone diseases,
- •Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment
- •Abnormal kidney or liver function
- •Other cancers within the last 5 years
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
ZOL446 (zoledronic acid)
Experimental
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
If and to what extent rising levels of the bone resorption marker CTX can be used as an indicator for the development of bone metastases, diagnosed via bone scintigraphy.
时间窗: at 6 months
次要结局
- If and to what extent rising levels of PSA can be used as an indicator for the development of bone metastases(at 6 months)
研究者
研究点 (2)
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