Efficacy and Safety of Single Dose of 5 mg Zoledronic Acid in Chinese Patients With Paget's Disease of Bone (PDB)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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.