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

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Zoledronic Acid 5 mg	Zoledronic Acid	Participants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF)	Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels	Baseline, Months 3 and 6	The percentage change in SAP at Months 3 and 6 relative to baseline were measured.
Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs)	6 months	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.
Percentage of Participants With SAP Within the Normal Range	Months 3 and 6	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.