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

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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: inclusion body myopathy with early-onset Paget disease and frontotemporal dementia juvenile Paget disease Paget disease of bone

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:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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

Locations

China
Novartis Investigative Site
Beijing, China
Novartis Investigative site
Guangzhou, China
Novartis Investigative site
Nanjing, China
Novartis Investigative site
Shanghai, China

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00774020 History of Changes
Other Study ID Numbers:	CZOL446K2419
Study First Received:	October 15, 2008
Last Updated:	November 24, 2010
Health Authority:	China: State Food and Drug Administration

Keywords provided by Novartis:

Paget's Disease of Bone
Serum Alkaline Phosphatase

Additional relevant MeSH terms:

Bone Diseases
Osteitis Deformans
Musculoskeletal Diseases
Zoledronic acid

Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012