Re-treatment of Patients With Paget's Disease Using Zoledronic Acid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00740129
First received: August 21, 2008
Last updated: April 30, 2013
Last verified: April 2013
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Reclast®/Aclasta®, Re-treatment of Relapsed Patients With Paget's Disease of Bone Who Participated in the CZOL446K2304 and CZOL446K2305 Core Registration Studies

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Normalization of total serum alkaline phosphatase within 6 months after a single 5 mg re-treatment dose of zoledronic acid [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Collect information pertaining to relapse diagnosis to define retreatment guidelines for Paget's disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in SAP levels relative to baseline [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]
  • Collect adverse events profile for re-treated patients [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Open label, single arm treatment study
Drug: Zoledronic Acid
Zoledronic acid 5 mg intravenous infusion once
Other Name: Reclast®/Aclasta®

Detailed Description:

Uncontrolled study

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
Novartis Investigative site
Brussels, Belgium
Canada
Novartis Investigative site
Montreal, Canada
Novartis Investigative site
Quebec, Canada
New Zealand
Novartis Investigative site
Aukland, New Zealand
South Africa
Novartis Investigative site
Cape Town, South Africa
Spain
Novartis Investigative site
Barcelona, Spain
Novartis Investigative site
Madrid, Spain
Novartis Investigative site
Salamanca, Spain
Novartis Investigative site
Valencia, Spain
United Kingdom
Novartis Investigative site
Nottingham, United Kingdom
Novartis Investigative site
Oxford, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00740129     History of Changes
Other Study ID Numbers: CZOL446K2418
Study First Received: August 21, 2008
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
South Africa: Medicines Control Council
European Union: European Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
New Zealand: Medsafe

Keywords provided by Novartis:
Paget's Disease
Zoledronic acid
Reclast®/Aclasta®
infusion
re-treatment
re-lapse

Additional relevant MeSH terms:
Bone Diseases
Osteitis Deformans
Musculoskeletal Diseases
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014