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®

Hypocalcemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668200
• Other study ID #: CZOL446K2401
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2008
• Last updated: February 17, 2015
• Start date: May 2008
• Est. completion date: November 2012

Study information

• Verified date: February 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Written informed consent

• As per currently approved Reclast® Package Insert:

Exclusion Criteria:

• As per currently approved Reclast® Package Insert:

Study Design

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

Related Conditions & MeSH terms

• Bone Diseases
• Hypocalcemia
• Osteitis Deformans
• Paget's Disease of the Bone

Intervention

Drug:
• Reclast (ZOL446, zoledronic acid)
5 mg i.v. annually ("real-life, physician prescribed")

Dietary Supplement:
• Calcium
1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)
• Vitamin D
800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Gainesville	Georgia
United States	Novartis Investigative Site	Madison	Wisconsin
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Providence	Rhode Island
United States	Novartis Investigative Site	Syracuse	New York
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Change From Baseline in Serum Calcium (mmol/L) - Safety Population	Change from baseline = endpoint - baseline, at each time point, only participants with a value at baseline and that time point are included in the change from baseline column. 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.	Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)	Yes
Secondary	Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)	The end of study is not a separate time point. It is the last post-baseline, for majority the end of study was visit 2. There were 2 patients who had the end of study at Visit 3. If calcium at visit 2 was abnormal it was measured again at visit 3.	End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)	Yes

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