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 PopulationPercentage 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
|