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

Novartis

Status and phase: Completed; Phase 4

Conditions: Paget's Disease of Bone

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00774020

CZOL446K2419

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Zoledronic acid