NCT00242554已完成4 期
Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
研究概览
简要总结
To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Histological confirmed diagnosis of carcinoma of the prostate
- •Current or previous evidence of metastatic disease to the bone
- •Receiving currently or not, hormonal therapy
- •ECOG performance status of 0, 1, or 2
排除标准
- •Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less.
- •Corrected serum calcium concentration, adjusted for serum albumin < 8.0 mg/dl (2.00 mmol/L).
- •WBC<3.0x10^9, ANC < 1500/mm3, Hb < 8.0 g/dL, platelets < 75 x 10^9/L.
- •Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
- •Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol.
- •Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula.
- •Other protocol-related inclusion / exclusion criteria may apply
结局指标
主要结局
To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
次要结局
- No secondary outcomes/objectives planned
研究者
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