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®

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2012

Interventions

  • 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)
  • Dietary Supplement: Vitamin D
    • 800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration

Arms, Groups and Cohorts

  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

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

  • As per currently approved Reclast® Package Insert:

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.