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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®

Primary Purpose

Paget's Disease of the Bone, Hypocalcemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Reclast (ZOL446, zoledronic acid)
Calcium
Vitamin D
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paget's Disease of the Bone focused on measuring Paget's, hypocalcemia, zoledronic acid, serum calcium

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent
  • As per currently approved Reclast® Package Insert:

Exclusion Criteria:

- As per currently approved Reclast® Package Insert:

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

zoledronic acid

Arm Description

5 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 22, 2008
Last Updated
February 17, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00668200
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 to Patients With Paget's Disease Treated With Reclast®
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 Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paget's Disease of the Bone, Hypocalcemia
Keywords
Paget's, hypocalcemia, zoledronic acid, serum calcium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zoledronic acid
Arm Type
Other
Arm Description
5 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.
Intervention Type
Drug
Intervention Name(s)
Reclast (ZOL446, zoledronic acid)
Other Intervention Name(s)
Reclast, ZOL446
Intervention Description
5 mg i.v. annually ("real-life, physician prescribed")
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium
Intervention Description
1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration
Primary Outcome Measure Information:
Title
Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.
Description
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.
Time Frame
at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Secondary Outcome Measure Information:
Title
Change From Baseline in Serum Calcium (mmol/L) - Safety Population
Description
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.
Time Frame
Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Title
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Description
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.
Time Frame
End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent As per currently approved Reclast® Package Insert: Exclusion Criteria: - As per currently approved Reclast® Package Insert:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Novartis Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723-0001
Country
United States
Facility Name
Novartis Investigative Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Novartis Investigative Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Novartis Investigative Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2306
Country
United States
Facility Name
Novartis Investigative Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Novartis Investigative Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Facility Name
Novartis Investigative Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-3611
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.novartisclinicaltrials.com
Description
Related Info

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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®

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