NCT00172003已完成4 期
Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of skeletal complications
研究概览
简要总结
It is the aim of this clinical study to evaluate the skeletal-related event rate under therapy with zoledronic acid in patients with renal cell cancer having at least one cancer-related bone lesion.
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
- All
- 接受健康志愿者
- 否
入选标准
- •A histologically confirmed diagnosis of renal cell carcinoma with none, one or, at maximum, 2 of the following risk factors:
- •Karnofsky performance status less than 80%
- •Lactate dehydrogenase greater than 1.5 times upper limit of normal
- •Hemoglobin less than lower limit of normal
- •Absence of nephrectomy
- •Patients must have evidence of at least one cancer-related bone lesion. If diagnosis of bone metastases in bone scan or magnetic resonance imaging (MRI)-QuickScan is unclear radiographic (X-ray, computed tomography [CT] or MRI) confirmation of at least one focus is required.
- •ECOG performance status of 0, 1 or
- •Life expectancy of ≥ 6 months
- •Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
- •Patient has given written informed consent prior to any study-specific procedures
排除标准
- •Only patients who received 3 or less applications of an i.v. Bisphosphonate in the past are eligible
- •Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) is allowed. However, other loci of bone metastasis must be present, which were not treated with radiation therapy and thus can be assessed for primary and secondary endpoints.
- •Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula: CrCl = [140-age (years)] x weight (kg) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)]
- •Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L)
- •Patients with clinically symptomatic brain metastases
- •History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
- •Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG.
- •Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
- •Pregnancy and lactation
- •Women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, intrauterine device [IUD], vaginal diaphragm or sponge, or condom with spermicide)
- •Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion
- •Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion
- •Participation in another trial
- •Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
- •Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
- •Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
- •Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Zoledronic acid
Experimental
Zoledronic acid, dosage according to calculated creatinine clearance, administered as a 15 minute infusion every 3 weeks for 12 months. Study infusion visits should occur not earlier than the scheduled visit and no later than 3 days after the scheduled visit. The dose of zoledronic acid in patients with baseline creatinine clearance > 60 mL/min was recommended to be 4 mg infused over no less than 15 minutes.
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Rate of skeletal complications
时间窗: continuous
次要结局
- Overall survival(continuous)
- Bone pain(every 9 weeks)
- Time to first skeletal complication(from first application of Zometa until confirmed skeletal related event (SRE))
- Time to overall progression of disease(continuous)
- Bone turnover parameters(every 9 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone MetastasisProstate Cancer Patients With Bone MetastasisNCT00237159Novartis Pharmaceuticals284
已完成
4 期
Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone MetastasesProstate CancerNCT00219219Novartis
进行中（未招募）
4 期
The effect of zolendronic acid on the clinical resolution of acute midfoot Charcot footCharcot neuroarthropathy in patients with diabetes mellitusMusculoskeletal - Other muscular and skeletal disordersMetabolic and Endocrine - DiabetesACTRN12611000065998Pirkanmaa Hospital District40
尚未招募
不适用
Effect of Zoledronic Acid Treatment on Bone-related Events in Breast Cancer Patients With Bone Metastases: a Prospective, Multicenter, Real-world StudyHistologically Confirmed Breast Cancer ,Diagnosis of Bone MetastasisNCT05480189Zhejiang Cancer Hospital1,000
已完成
不适用
Efficacy of Zoledronic Acid in Osteoporosis of Children With Multiple DisabilitiesMultiple DisabilityOsteoporosisNCT03301285Central Hospital, Nancy, France60