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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Paget's Disease of the Bone, Hypocalcemia

Intervention / Treatment
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* Drug: Reclast (ZOL446, zoledronic acid)
* Dietary Supplement: Calcium
* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent As per currently approved Reclast® Package Insert: Exclusion Criteria: - As per currently approved Reclast® Package Insert:
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: zoledronic acid<br>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. | Drug: Reclast (ZOL446, zoledronic acid)<br>* 5 mg i.v. annually (real-life, physician prescribed)<br>* Other names: Reclast, ZOL446;Dietary Supplement: Calcium<br>* 1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)<br>Dietary Supplement: Vitamin D<br>* 800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paget's, hypocalcemia, zoledronic acid, serum calcium