Re-Treatment of Patients With Paget's Disease Using Zoledronic Acid - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00740129

Purpose

The purpose of this study is to demonstrate that patients with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5mg infusion of zoledronic acid.

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

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

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	An Open Label, Zoledronic Acid, re-Treatment of Relapsed Patients With Paget's Disease of the Bone Who Participated in the CZOL446K2304 and CZOL446K2305 Core Registration Studies

Further study details as provided by Novartis:

Primary Outcome Measures:

Normalization of total serum alkaline phosphates within 6 months after a single 5 mg re-treatment dose

Secondary Outcome Measures:

Collect information pertaining to relapse diagnosis to define guidelines for Paget's disease
Changes in SAP levels at 3 and 6 months post re-treatment
Collect adverse events profile for re-treated patients

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Open label, single arm treatment study	Drug: Zoledronic Acid

Eligibility

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Written Informed Consent
Patients with Paget's disease randomized to the zoledronic acid arm from the CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months
Confirmed relapse of Paget's disease of bone (i.e. SAP above ULN, bone scan, worsening clinical symptoms)

Exclusion Criteria:

A patient previously treated with zoledronic acid who relapsed and was retreated with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months
Bisphosphonate Hypersensitivity
Patients with suspected/proven metastases at re-treatment
Calculated creatinine clearance <35 mL/min at screening
Serum calcium level <2.07 mmol/L at screening
Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or hypothyroidism

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740129

Contacts

Contact: Novartis Pharmaceuticals, for US sites	862-778-8300
Contact: Novartis Pharma, AG, for non US sites	41 61 324 11 11

Locations

Belgium
Novartis Investigative site
Brussels, Belgium
Canada
Novartis Investigative site
Quebec, Canada
Novartis Investigative site
Montreal, Canada
Spain
Novartis Investigative site
Valencia, Spain
Novartis Investigative site
Barcelona, Spain
Novartis Investigative site
Madrid, Spain
Novartis Investigative site
Salamanca, Spain
Novartis Investigative site
Santiago de Compostela, Spain
United Kingdom
Novartis Investigative site
Nottingham, United Kingdom
Novartis Investigative site
Liverpool, United Kingdom
Novartis Investigative site
Oxford, United Kingdom

Sponsors and Collaborators

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CZOL446K2418
Study First Received:	August 21, 2008
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00740129
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration; South Africa: Medicines Control Council; European Union: European Medicines Agency; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Novartis:

Paget's Disease
Zoledronic acid
Reclast®/Aclasta®

infusion
re-treatment
re-lapse

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Musculoskeletal Diseases
Osteitis Deformans

Osteitis
Bone Diseases
Pagets disease

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009