Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
- Registration Number
- NCT00774020
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Confirmed diagnosis of PDB by radiological reports
- Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Zoledronic acid -
- Primary Outcome Measures
Name Time Method 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. at the end of 3 months and 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Novartis Investigative Site
🇨🇳Beijing, China
Novartis Investigative site
🇨🇳Shanghai, China