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

• Status: Completed
• Trial end date: 2011-01-14
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

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.