NCT00489905已完成不适用
Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2005年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Bone mineral density of femoral neck
研究概览
简要总结
The purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline BMD in between -2 standard deviation (SD) and mean of that among young adults.
排除标准
- •Patients with renal or liver problems, on calcium or other bisphosphonate therapy within six months before enrolling into the study.
- •Patients who have:
- •Serum creatinine levels >212 µmol/L (2.4 mg/dL).
- •Creatinine clearance <50 ml/min.
- •WBC <4.0x109/L, Hgb <10 g/dL, platelets <140x109/L. Patients with known hypersensitivity to bisphosphonates. Patients with history of diseases with influence on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or osteoporosis.
结局指标
主要结局
Bone mineral density of femoral neck
时间窗: 12 months after administration of zolderonic acid
Bone mineral density of lumber spine
时间窗: 12 months after administration of zolderonic acid
次要结局
- Change in creatinine clearance(From time of enrollment to 3 months after the last intervention)
- Change in serum creatinine, calcium, phosphate and alkaline phosphatase(From time of enrollment to 3 months after the last intervention)
研究者
研究点 (1)
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