NCT00375648已完成3 期
Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With 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
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief)
研究概览
简要总结
This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven adenocarcinoma of the prostate
- •Bone-scan documented metastases
- •Age > 18 years
- •Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion
- •Life expectancy > 3 months
- •Written informed consent
排除标准
- •New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks
- •Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry
- •Bisphosphonate therapy within 8 weeks before study entry
- •Abnormal renal function (serum creatinine > 2 x the upper normal limit or creatinine clearance < 30 ml/min)
- •Corrected serum calcium > 3 mmol/L or < 2 mmol/L
- •Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug
- •Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain
- •Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.)
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
zoledronate
Experimental
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief)
时间窗: at 12 weeks or at 16 weeks (end of treatment)
次要结局
- To measure the intensity of the pain relief of the patients with the PAR at each visit(every 3 or 4 weeks during 12 to 16 weeks)
- To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal(at 12 weeks or at 16 weeks (end of treatment))
- To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5.(every 3 or 4 weeks during 12 to 16 weeks)
- To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale)(every 3 or 4 weeks during 12 to 16 weeks)
- To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5(every 3 or 4 weeks during 12 to 16 weeks)
- To evaluate the duration of responses(at 12 weeks or at 16 weeks (end of treatment))
- To evaluate the number of skeletal related events by patient(every 3 or 4 weeks during 12 to 16 weeks)
- To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5(every 3 or 4 weeks during 12 to 16 weeks)
研究者
研究点 (1)
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