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Syracuse, New York 13210

  • Hypocalcemia

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.


Criteria:

Inclusion Criteria: - Written informed consent - As per currently approved Reclast® Package Insert: Exclusion Criteria: - As per currently approved Reclast® Package Insert:


Study is Available At:


Original ID:

CZOL446K2401


NCT ID:

NCT00668200


Secondary ID:


Study Acronym:


Brief Title:

Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

85


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:May 2008
Completion Date:November 2012
Completion Type:Actual
Primary Completion Date:November 2012
Primary Completion Type:Actual
Verification Date:February 2013
Last Changed Date:February 8, 2013
First Received Date:April 22, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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 c
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:ZOL446
Description:5mg i.v. annually ("real-life, physican prescribed")
Arm Name:Single arm
Other Name:zoledronic acid, Aclasta®

Study Arms

Study Arm Type:Other
Arm Name:Single arm
Description:Open label, single arm treatment study

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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