Clinical Trial: 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®

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ad

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.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: 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) ]

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.


Original Primary Outcome: 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

Current Secondary Outcome:

  • Change From Baseline in Serum Calcium (mmol/L) - Safety Population [ Time Frame: Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30) ]
    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) ]
    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.


Original Secondary Outcome: 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

Information By: Novartis

Dates:
Date Received: April 22, 2008
Date Started: May 2008
Date Completion:
Last Updated: February 17, 2015
Last Verified: February 2015