NCT00774020已完成4 期
A 6 Months, Open-Label Phase IV Study to Confirm the Safety and Efficacy of Single Intravenous Dose of 5 mg Zoledronic Acid for the Patients of Paget's Disease of Bone (PDB) in China
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
- 9
- 试验地点
- 2
- 主要终点
- The proportion of patients who achieve therapeutic response (a reduction of at least 75% from baseline in total Serum Alkaline Phosphatase (SAP) excess or normalization of SAP.
研究概览
简要总结
The purpose of this study is to document the efficacy and safety profiles of single intravenous dose of 5 mg zoledronic acid for the Chinese patients of Paget's Disease of Bone (PDB).
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of PDB by radiological reports
- •Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)
排除标准
- •History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates;
- •History of malignancy of any organ system
- •Severe liver or bladder disease;
- •Calculated creatinine clearance < 35 mL/min at baseline;
- •Hypocalcaemia;
- •Patients with pre-existing dental diseases or who predict to have dental surgeries during the study;
- •Evidence of vitamin D deficiency.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
The proportion of patients who achieve therapeutic response (a reduction of at least 75% from baseline in total Serum Alkaline Phosphatase (SAP) excess or normalization of SAP.
时间窗: at the end of 3 months and 6 months
次要结局
- The percent change from baseline in total Serum Alkaline Phosphatase (SAP).(at the end of 3 months and 6 months)
- The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX).(at the end of 3 months and 6 months)
研究者
研究点 (2)
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