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 currently recruiting participants.

Verified by Novartis, December 2008

First Received: April 22, 2008 Last Updated: December 15, 2008 History of Changes

Sponsored by:	Novartis Pharmaceuticals
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

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Diseases Calcium Dietary Supplements Paget's Disease of Bone

Drug Information available for: Zoledronic acid Calcium gluconate Vitamin D

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of unresolved and resolved hypocalcemic events based on serum calcium measurements. [ Time Frame: at days 9 - 11 and, if needed, day 30, compared to baseline values and to historical controls ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Identify the incidence of symptoms associated with hypocalcemia based on responses to questionnaires. [ Time Frame: at days 9 - 11 and, if needed, day 30, compared to baseline ] [ Designated as safety issue: Yes ]

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)

Arms	Assigned Interventions
Single arm Open label, single arm treatment study	Drug: Reclast®

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent
As per Reclast® Package Insert:

Exclusion Criteria:

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

862-778-8300

Locations

United States, Arizona
Novartis Investigative site	Recruiting
Tucson, Arizona, United States, 85723
Novartis Investigative Site	Recruiting
Phoenix, Arizona, United States, 85012
United States, California
Novartis Investigative site	Recruiting
Los Angeles, California, United States, 90095
United States, Colorado
Novartis Investigative site	Recruiting
Aurora, Colorado, United States, 80010
United States, Georgia
Novartis Investigative site	Recruiting
Gainesville, Georgia, United States, 30501
United States, Massachusetts
Novartis Investigative site	Recruiting
Boston, Massachusetts, United States, 02118
United States, Rhode Island
Novartis Investigative site	Recruiting
Providence, Rhode Island, United States, 02908
United States, Texas
Novartis Investigative Site	Recruiting
Fort Worth, Texas, United States, 76107
Novartis Investigative site	Recruiting
Houston, Texas, United States, 77004
Novartis Investigative site	Recruiting
Dallas, Texas, United States, 75216
Novartis Investigative site	Recruiting
Waco, Texas, United States, 76708
United States, Wisconsin
Novartis Investigative site	Recruiting
Madison, Wisconsin, United States, 53705

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CZOL446K2401
Study First Received:	April 22, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00668200 History of Changes
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
Metabolic Diseases
Zoledronic acid
Bone Density Conservation Agents
Bone Diseases
Calcium, Dietary
Vitamin D

Musculoskeletal Diseases
Vitamins
Osteitis Deformans
Water-Electrolyte Imbalance
Paget Disease
Osteitis
Metabolic Disorder

Additional relevant MeSH terms:

Calcium Metabolism Disorders
Hypocalcemia
Zoledronic acid
Metabolic Diseases
Musculoskeletal Diseases
Physiological Effects of Drugs

Osteitis Deformans
Bone Density Conservation Agents
Water-Electrolyte Imbalance
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 06, 2009