Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
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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. [ Time Frame: at the end of 3 months and 6 months ]
Secondary Outcome Measures :
The percent change from baseline in total Serum Alkaline Phosphatase (SAP). [ Time Frame: 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). [ Time Frame: at the end of 3 months and 6 months ]
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Ages Eligible for Study:
30 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Confirmed diagnosis of PDB by radiological reports
Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN)
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;
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.