An Open Label, Reclast®/Aclasta®, Re-treatment of Relapsed Patients With Paget's Disease of Bone Who Participated in the CZOL446K2304 and CZOL446K2305 Core Registration Studies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF)
研究概览
简要总结
The purpose of this study was to demonstrate that participants with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zoledronic acid.
详细描述
Uncontrolled study
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent
- •Participants with Paget's disease randomized to the zoledronic acid arm from the CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months
- •Confirmed relapse of Paget's disease of bone (i.e., serum alkaline phosphatase (SAP) above upper limit of normal (ULN), bone scan, worsening clinical symptoms)
排除标准
- •A participant previously treated with zoledronic acid who relapsed and was retreated with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months
- •Bisphosphonate Hypersensitivity
- •Participants with suspected/proven metastases at re-treatment
- •Calculated creatinine clearance <35 milliliter/minute (mL/min) at screening
- •Serum calcium level <2.07 millimole/liter (mmol/L) at screening
- •Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or hypothyroidism
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Zoledronic Acid 5 mg
Participants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion.
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF)
时间窗: Month 6
Normalization of serum alkaline phosphatase (SAP) occurred if the SAP measurement fell within the normal ranges. The lower and upper limits of normal ranges were 31 and 110 Units/Liter (U/L) for participants with age ≤ 58 years old and 35 and 115 U/L for participants with age \> 58 years old, respectively. Last observation carried forward (LOCF) was defined as the last post-baseline SAP value prior to month 6 for a participant who did not have an SAP value at month 6.
次要结局
- Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels(Baseline, Months 3 and 6)
- Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs)(6 months)
- Percentage of Participants With SAP Within the Normal Range(Months 3 and 6)