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 October 2011 by Novartis

First Received on April 22, 2008. Last Updated on October 7, 2011 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
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:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: inclusion body myopathy with early-onset Paget disease and frontotemporal dementia juvenile Paget disease Paget disease of bone

MedlinePlus related topics: Bone Diseases Calcium Paget's Disease of Bone Vitamin D

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 post-infusion 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 post-infusion and, if needed, day 30, compared to baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	May 2008
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single arm Open label, single arm treatment study	Drug: Reclast® 5mg i.v. annually ("real-life, physican prescribed") Other Name: zoledronic acid, Aclasta®

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent
As per currently approved Reclast® Package Insert:

Exclusion Criteria:

- As per currently approved Reclast® Package Insert:

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	Completed
Phoenix, Arizona, United States, 85012
Novartis Investigative site	Recruiting
Tucson, Arizona, United States, 85723
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, Michigan
Michigan Bone and Mineral Clinic, PC	Recruiting
Detroit, Michigan, United States, 48236
United States, New York
Novartis Investigative Site	Recruiting
New Hyde Park, New York, United States, 11042
Novartis Investigative Site	Recruiting
Syracuse, New York, United States, 13210
United States, Rhode Island
Novartis Investigative site	Recruiting
Providence, Rhode Island, United States, 02908
United States, Texas
Novartis Investigative site	Recruiting
Dallas, Texas, United States, 75216
Novartis Investigative Site	Recruiting
Fort Worth, Texas, United States, 76107
Novartis Investigative site	Recruiting
Houston, Texas, United States, 77004
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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00668200 History of Changes
Other Study ID Numbers:	CZOL446K2401
Study First Received:	April 22, 2008
Last Updated:	October 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Paget's
hypocalcemia
zoledronic acid
serum calcium

Additional relevant MeSH terms:

Bone Diseases
Hypocalcemia
Osteitis Deformans
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Zoledronic acid

Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 12, 2012