Re-treatment of Participants With Paget's Disease Using Zoledronic Acid

Study Overview
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Brief Summary
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The purpose of this study was to demonstrate that participants with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zoledronic acid.

Detailed Description
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Uncontrolled study

Official Title
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An Open Label, Reclast®/Aclasta®, Re-treatment of Relapsed Patients With Paget's Disease of Bone Who Participated in the CZOL446K2304 and CZOL446K2305 Core Registration Studies

Conditions
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Paget's Disease of the Bone

Intervention / Treatment
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* Drug: Zoledronic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent Participants with Paget's disease randomized to the zoledronic acid arm from the CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months Confirmed relapse of Paget's disease of bone (i.e., serum alkaline phosphatase (SAP) above upper limit of normal (ULN), bone scan, worsening clinical symptoms) Exclusion Criteria: A participant previously treated with zoledronic acid who relapsed and was retreated with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months Bisphosphonate Hypersensitivity Participants with suspected/proven metastases at re-treatment Calculated creatinine clearance <35 milliliter/minute (mL/min) at screening Serum calcium level <2.07 millimole/liter (mmol/L) at screening Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or hypothyroidism Other protocol-defined inclusion/exclusion criteria may apply.
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoledronic Acid 5 mg<br>Participants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion. | Drug: Zoledronic Acid<br>* Zoledronic acid 5 mg intravenous infusion once<br>* Other names: Reclast®/Aclasta®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF) | Normalization of serum alkaline phosphatase (SAP) occurred if the SAP measurement fell within the normal ranges. The lower and upper limits of normal ranges were 31 and 110 Units/Liter (U/L) for participants with age ≤ 58 years old and 35 and 115 U/L for participants with age > 58 years old, respectively. Last observation carried forward (LOCF) was defined as the last post-baseline SAP value prior to month 6 for a participant who did not have an SAP value at month 6. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels | The percentage change in SAP at Months 3 and 6 relative to baseline were measured. | Baseline, Months 3 and 6 | 
| Percentage of Participants With SAP Within the Normal Range | Normalization of SAP occurred if the SAP measurement fell within the normal ranges. The lower and upper limits of normal ranges were 31 and 110 Units/Liter (U/L) for participants with age ≤ 58 years old and 35 and 115 U/L for participants with age > 58 years old, respectively. | Months 3 and 6 | 
| Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs) | Adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition that occurred after starting the study drug even if the event was not considered to be related to study drug. TEAEs were defined as AEs that were absent prior to, but occurred after the i.v. infusion of study drug. TEAEs also included those that were present prior to the i.v. study drug infusion (i.e., as part of the extended observation period) but occurred at an increased severity after the i.v. infusion of study drug. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paget's Disease, Zoledronic acid, Reclast®/Aclasta®, Infusion, Re-treatment, Re-lapse