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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®

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Paget's Disease of the Bone; Hypocalcemia

Intervention: Reclast (ZOL446, zoledronic acid) (Drug); Calcium (Dietary Supplement); Vitamin D (Dietary Supplement)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.

Secondary outcome:

Change From Baseline in Serum Calcium (mmol/L) - Safety Population

Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Written informed consent

- As per currently approved Reclast® Package Insert:

Exclusion Criteria:

- As per currently approved Reclast® Package Insert:

Locations and Contacts

Novartis Investigative Site, Phoenix, Arizona 85012, United States

Novartis Investigative Site, Tucson, Arizona 85723-0001, United States

Novartis Investigative Site, Gainesville, Georgia 30501, United States

Novartis Investigative Site, Detroit, Michigan 48236, United States

Novartis Investigative Site, Syracuse, New York 13210-2306, United States

Novartis Investigative Site, Providence, Rhode Island 02908, United States

Novartis Investigative Site, Dallas, Texas 75216, United States

Novartis Investigative Site, Waco, Texas 76708, United States

Novartis Investigative Site, Madison, Wisconsin 53705-3611, United States

Additional Information

Starting date: May 2008
Last updated: February 17, 2015

Page last updated: August 23, 2015

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