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® - Tabular View

Tracking Information

First Received Date ^ICMJE

April 22, 2008

Last Updated Date

December 15, 2008

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00668200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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®

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Paget's Disease of the Bone
Hypocalcemia

Intervention ^ICMJE

Drug: Reclast®

Study Arms / Comparison Groups

Other: Open label, single arm treatment study

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

862-778-8300

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00668200

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CZOL446K2401

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP