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

Primary Purpose

Paget's Disease of the Bone

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paget's Disease of the Bone focused on measuring Paget's Disease, Zoledronic acid, Reclast®/Aclasta®, Infusion, Re-treatment, Re-lapse

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site
  • Novartis Investigative site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zoledronic Acid 5 mg

Arm Description

Participants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
August 21, 2008
Last Updated
May 3, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00740129
Brief Title
Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2008 (Actual)
Primary Completion Date
March 14, 2011 (Actual)
Study Completion Date
March 14, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Uncontrolled study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paget's Disease of the Bone
Keywords
Paget's Disease, Zoledronic acid, Reclast®/Aclasta®, Infusion, Re-treatment, Re-lapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic Acid 5 mg
Arm Type
Experimental
Arm Description
Participants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Other Intervention Name(s)
Reclast®/Aclasta®
Intervention Description
Zoledronic acid 5 mg intravenous infusion once
Primary Outcome Measure Information:
Title
Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF)
Description
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 Outcome Measure Information:
Title
Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels
Description
The percentage change in SAP at Months 3 and 6 relative to baseline were measured.
Time Frame
Baseline, Months 3 and 6
Title
Percentage of Participants With SAP Within the Normal Range
Description
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
Title
Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs)
Description
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
Other Pre-specified Outcome Measures:
Title
Collect Information Pertaining to Relapse Diagnosis to Define Retreatment Guidelines for Paget's Disease
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Novartis Investigative site
City
Brussels
Country
Belgium
Facility Name
Novartis Investigative site
City
Montreal
Country
Canada
Facility Name
Novartis Investigative site
City
Quebec
Country
Canada
Facility Name
Novartis Investigative site
City
Auckland
Country
New Zealand
Facility Name
Novartis Investigative site
City
Cape Town
Country
South Africa
Facility Name
Novartis Investigative site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative site
City
Madrid
Country
Spain
Facility Name
Novartis Investigative site
City
Salamanca
Country
Spain
Facility Name
Novartis Investigative site
City
Valencia
Country
Spain
Facility Name
Novartis Investigative site
City
Nottingham
Country
United Kingdom
Facility Name
Novartis Investigative site
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24422139
Citation
Reid IR, Brown JP, Levitt N, Roman Ivorra JA, Bachiller-Corral J, Ross IL, Su G, Antunez-Flores O, Aftring RP. Re-treatment of relapsed Paget's disease of bone with zoledronic acid: results from an open-label study. Bonekey Rep. 2013 Nov 6;2:442. doi: 10.1038/bonekey.2013.176. eCollection 2013.
Results Reference
result

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

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