ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®

This study is not yet open for participant recruitment.
Verified by Novartis, April 2008

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00668200
  Purpose

This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.


Condition Intervention Phase
Paget's Disease of the Bone
Hypocalcemia
Drug: Reclast®
Phase IV

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

ChemIDplus related topics:   Zoledronic acid    Calcium gluconate    Vitamin D    Ergocalciferol   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Post US Approval Voluntary Registry Study to Determine Incidence of Hypocalcemia Post Reclast® Treatment in Patients With Paget's Disease After Institution of Educational Strategies to Improve Adherence to Calcium and Vitamin D Supplementation

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of unresolved and resolved hypocalcemic events at days 9 - 11 and, if needed, day 30, compared to baseline values and to historical controls. Based on serum calcium measurements

Secondary Outcome Measures:
  • Identify the incidence of symptoms associated with hypocalcemia based on responses to questionnaires at Days 9 - 11 and, if needed, Day 30, compared to baseline

Estimated Enrollment:   300
Study Start Date:   May 2008
Estimated Study Completion Date:   January 2010
Estimated Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
Single arm
Open label, single arm treatment study
Drug: Reclast®

  Eligibility
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

  • Written informed consent
  • As per Reclast® Package Insert:

Exclusion Criteria:

  • As stated in the Protocol, "As per Reclast® Package Insert"

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668200

Contacts
Contact: Novartis Pharmaceuticals, New Jersey     862-778-8300    

Locations
United States, Arizona
Not yet recruiting
      Tucson, Arizona, United States, 85723
United States, Colorado
Not yet recruiting
      Aurora, Colorado, United States, 80010
United States, Florida
Not yet recruiting
      Jacksonville, Florida, United States, 32209
United States, Illinois
Not yet recruiting
      Maywood, Illinois, United States, 60153
United States, Rhode Island
Not yet recruiting
      Providence, Rhode Island, United States, 02908
United States, Texas
Not yet recruiting
      Fort Worth, Texas, United States, 76107
Not yet recruiting
      Houston, Texas, United States, 77004
Not yet recruiting
      Dallas, Texas, United States, 75216
Not yet recruiting
      Waco, Texas, United States, 76708

Sponsors and Collaborators
Novartis
  More Information


Responsible Party:   Novartis ( External Affairs )
Study ID Numbers:   CZOL446K2401
First Received:   April 22, 2008
Last Updated:   April 25, 2008
ClinicalTrials.gov Identifier:   NCT00668200
Health Authority:   United States: Food and Drug Administration

Keywords provided by Novartis:
Paget's  
hypocalcemia  
zoledronic acid  
serum calcium  

Study placed in the following topic categories:
Hypocalcemia
Vitamin D
Zoledronic acid
Metabolic Diseases
Musculoskeletal Diseases
Osteitis Deformans
Ergocalciferols
Water-Electrolyte Imbalance
Metabolic disorder
Osteitis
Bone Diseases
Pagets disease

Additional relevant MeSH terms:
Calcium Metabolism Disorders
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers