NCT00424983已完成1 期
A Stratified, Randomized, Open-label, Multi-center Comparative 2-arm Trial of PK, PD, and Safety of Zoledronic Acid Infusions Administered Monthly vs. Every 3-month, in Multiple Myeloma Patients With Malignant Bone Lesions, and Breast Cancer Patients With Bone Metastasis, Who Have Received 9-12* Doses of Zoledronic Acid Over the Prior Year. (*Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines, the Title Has Not Been Changed)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 7
- 主要终点
- Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
研究概览
简要总结
The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18-75 years of age
- •Multiple myeloma or breast cancer with bone involvement
- •Treatment with zoledronic acid for bone lesions between 10-15 months prior to entry into study with a total of 9-20 infusions received.
排除标准
- •Current active dental problems or recent (within 8 weeks) or planned dental or jaw surgery
- •Active or uncontrolled infection, liver, or renal disease
- •History of treatment with intravenous bisphosphonates
- •Diagnosis of metabolic bone disorders other than osteoporosis (e.g. Paget's disease)
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Zometa q 4 weeks
Experimental
干预措施: Zoledronic acid (Drug)
Zometa q 12 weeks
Active Comparator
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
时间窗: every four (4) weeks
Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13
时间窗: every four (4) weeks
次要结局
- Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits.(every four (4) weeks)
- Efficacy outcomes will be measured throughout the study by number and time to skeletal related events (determined by bone surveys and bone scans) as well as the measurement of pain and analgesic scores.(bone survey = every 12 weeks; bone scan = every 24 weeks; pain & analgesic scores = weekly prior to visit 8 (inclusive), every 4 weeks after visit 8)
研究者
研究点 (7)
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