NCT00838201已完成3 期
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Overall Survival Through Month 24
研究概览
简要总结
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must be currently participating in the 20040138 Amgen study
- •Subjects must sign the informed consent before any study specific procedures are performed.
- •Exclusion Criteria
- •Subjects with any prior diagnosis of bone metastasis
- •Known hypocalcemia
- •Developed sensitivity to mammalian cell derived drug products during the 20040138 study
- •Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study
- •Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Experimental
干预措施: Denosumab (Drug)
结局指标
主要结局
Overall Survival Through Month 24
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
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