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

Paget's Disease of Bone Clinical Trial

Official title:

A 6 Months, Open-Label Phase IV Study to Confirm the Safety and Efficacy of Single Intravenous Dose of 5 mg Zoledronic Acid for the Patients of Paget's Disease of Bone (PDB) in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774020
• Other study ID #: CZOL446K2419
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2008
• Last updated: February 21, 2017
• Start date: October 30, 2008
• Est. completion date: January 14, 2011

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 14, 2011
• Est. primary completion date: January 14, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases
• Osteitis Deformans
• Paget's Disease of Bone

Intervention

Drug:
• Zoledronic acid
5mg, i.v. single dose

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing
China	Novartis Investigative site	Guangzhou
China	Novartis Investigative site	Nanjing
China	Novartis Investigative site	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		at the end of 3 months and 6 months
Secondary	The percent change from baseline in total Serum Alkaline Phosphatase (SAP).		at the end of 3 months and 6 months
Secondary	The percent change from baseline in serum cross-linked C-telopeptide of type I collagen (CTX).		at the end of 3 months and 6 months

External Links

•   Results for CZOL446K2419 from the Novartis Clinical Trials website.