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®
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
1 other identifier
interventional
81
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2008
Longer than P75 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2008
CompletedFirst Posted
Study publicly available on registry
April 29, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
March 3, 2014
CompletedMarch 6, 2015
February 1, 2015
4.5 years
April 22, 2008
November 4, 2013
February 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.
To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium \<2.07 mmol/L at 9-11 days after the study drug infusion.
at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Secondary Outcomes (2)
Change From Baseline in Serum Calcium (mmol/L) - Safety Population
Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)
Study Arms (1)
zoledronic acid
OTHER5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
Interventions
5 mg i.v. annually ("real-life, physician prescribed")
1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)
800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration
Eligibility Criteria
You may qualify if:
- Written informed consent
- As per currently approved Reclast® Package Insert:
You may not qualify if:
- \- As per currently approved Reclast® Package Insert:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2008
First Posted
April 29, 2008
Study Start
May 1, 2008
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
March 6, 2015
Results First Posted
March 3, 2014
Record last verified: 2015-02