NCT00237146已完成4 期
Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Evaluate the effects of Zometa® (Zoledronic Acid) i.v in doses of 4mg for measure the following parameters of efficacy: Quality of Life, Incidence of Events related to the skeleton
研究概览
简要总结
An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.
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
- •histologically confirmed adenocarcinoma of the prostate.
- •Orchidectomy within the four previous weeks to enter the study.
- •bone metastasis evidenced by bone scan.
- •A hip DEXA study with a DS <
- •No hormonal therapy previous to enter the study.
- •ECOG performance score of 0-
- •Signed written informed consent.
排除标准
- •Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.
- •Any kind of hormonal therapy for prostate cancer previous to enter the study.
- •Serum calcium corrected for albumin level < 8.0 mg/dl.
- •WBC < 3.0x10^3, ANC < 1500/mm3, Hemoglobin < 8.0 g/dl, platelets < 75 x 10^3/l.
- •Abnormal hepatic function evidenced by ALT and AST value >2.5 UNL
- •Subjects with any other malignant disease that can affect the bone.
- •Subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations.
- •Known hypersensibility to zoledronic acid or other bisphosphonates.
- •Subjects that in the investigator's opinion can not cooperate with the protocol.
- •Other protocol inclusion/exclusion criteria may apply.
研究组 & 干预措施
Zoledronic Acid
Experimental
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Evaluate the effects of Zometa® (Zoledronic Acid) i.v in doses of 4mg for measure the following parameters of efficacy: Quality of Life, Incidence of Events related to the skeleton
次要结局
未报告次要终点
研究者
研究点 (1)
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