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®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00668200
First received: April 22, 2008
Last updated: October 14, 2014
Last verified: October 2014

April 22, 2008
October 14, 2014
May 2008
November 2012   (final data collection date for primary outcome measure)
Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid. [ Time Frame: at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30) ] [ Designated as safety issue: Yes ]
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.
Incidence of unresolved and resolved hypocalcemic events at days 9 - 11 and, if needed, day 30, compared to baseline values and to historical controls. Based on serum calcium measurements
Complete list of historical versions of study NCT00668200 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Serum Calcium (mmol/L) - Safety Population [ Time Frame: Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30) ] [ Designated as safety issue: Yes ]
    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.
Identify the incidence of symptoms associated with hypocalcemia based on responses to questionnaires at Days 9 - 11 and, if needed, Day 30, compared to baseline
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Paget's Disease of the Bone
  • Hypocalcemia
  • Drug: Reclast (ZOL446, zoledronic acid)
    5 mg i.v. annually ("real-life, physician prescribed")
    Other Name: Reclast, ZOL446
  • Dietary Supplement: Calcium
    1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)
  • Dietary Supplement: Vitamin D
    800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration
zoledronic acid
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.
Interventions:
  • Drug: Reclast (ZOL446, zoledronic acid)
  • Dietary Supplement: Calcium
  • Dietary Supplement: Vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

- As per currently approved Reclast® Package Insert:

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00668200
CZOL446K2401
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP