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

This study is currently recruiting participants.

Verified by Novartis, November 2009

First Received: October 15, 2008 Last Updated: November 12, 2009 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00774020

Purpose

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).

Condition	Intervention	Phase
Paget's Disease of Bone	Drug: Zoledronic acid	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Diseases Paget's Disease of Bone

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Zoledronic acid 5mg, i.v. single dose

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774020

Contacts

Contact: Novartis Pharmaceuticals

+41 61 324 1111

Locations

China
Novartis Investigative Site	Recruiting
Beijing, China
Novartis Investigative site	Recruiting
Shanghai, China
Novartis Investigative site	Not yet recruiting
Nanjing, China
Novartis Investigative site	Recruiting
Guangzhou, China

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446K2419
Study First Received:	October 15, 2008
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00774020 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Novartis:

Paget's Disease of Bone
Serum Alkaline Phosphatase

Additional relevant MeSH terms:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Physiological Effects of Drugs

Osteitis Deformans
Bone Density Conservation Agents
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009