NCT00171964已完成4 期
Evaluation of the Efficacy and Tolerability of Zoledronic Acid in Combination With Radiotherapy in Patients With Advanced Osteolytic Bone Lesions
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
- 75
- 试验地点
- 1
- 主要终点
- Pain reduction
研究概览
简要总结
It is the aim of this multicentric clinical study to assess the efficacy and tolerability of zoledronic acid in combination with radiotherapy in patients with advanced osteolytic bone lesions in terms of the reduction of pain and analgesic consumption.
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
- •Diagnosis of at least one cancer-related bone lesion in cancer patients, confirmed by X-ray, MRT or computer tomography
- •Severity of pain ≥ 5 on item 3 of the BPI which is caused by the bone lesion(s) and requires radiotherapy
- •Adequate liver function - serum total bilirubin concentration less than 1.5 x the upper limit of normal value
- •Expected survival time ≥ 6 months
- •If the patient is of child-bearing potential: negative pregnancy test at screening
- •ECOG performance status of 0, 1 or
- •Written informed consent
排除标准
- •Prior treatment with an oral bisphosphonate for more than 3 months or more than 3 intravenous (i.v.) bisphosphonate applications
- •Bisphosphonate treatment within 6 months before study start
- •Previous radiotherapy of the painful areas to be irradiated. An initiation of radiotherapy for the target area(s) up to 3 days at maximum prior to the first infusion is allowed.
- •Skeleton-related complications (e.g., pathological fractures, orthopedic intervention to treat or stabilize an osteolytic defect, spinal cord compression) during the last 3 weeks prior to the first infusion of trial medication.
- •Initiation of a new chemotherapeutic treatment regimen during the last 2 weeks prior to the first infusion of trial medication
- •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
- •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)
- •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/exclusion criteria may apply.
研究组 & 干预措施
zoledronic acid + radiotherapy
Experimental
zoledronic acid every 4 weeks in combination with radiotherapy
干预措施: Zoledronic acid in combination with therapy (Drug)
结局指标
主要结局
Pain reduction
时间窗: weekly assessments during 48 weeks
次要结局
- Quality of life(weeks 0, 12, 24, 36, 48 and 60)
- Duration of pain reduction(weeks 0, 12, 24, 36, 48 and 60)
- Changes in parameters of bone turnover(weeks 0, 12, 24, 36, 48 and 60)
- Time to pain reduction(weeks 0, 12, 24, 36, 48 and 60)
研究者
研究点 (1)
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