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

Novartis Pharmaceuticals6 enrolled

Overview

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.

Uncontrolled study

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Paget's Disease of the Bone

Interventions

Zoledronic AcidDRUG

Zoledronic acid 5 mg intravenous infusion once

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (11)

Novartis Investigative site

Brussels, Belgium

Novartis Investigative site

Montreal, Canada

Novartis Investigative site

Québec, Canada

Novartis Investigative site

Outcomes

Primary Outcomes

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.

Time frame: Month 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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