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® - Full Text View

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