Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)

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

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).

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.