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