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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00740129
Registration number
NCT00740129
Ethics application status
Date submitted
21/08/2008
Date registered
22/08/2008
Date last updated
26/05/2021
Titles & IDs
Public title
Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
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Scientific 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
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Secondary ID [1]
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2008-002898-12
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Secondary ID [2]
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CZOL446K2418
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Paget's Disease of the Bone
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic Acid
Experimental: Zoledronic Acid 5 mg - Participants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion.
Treatment: Drugs: Zoledronic Acid
Zoledronic acid 5 mg intravenous infusion once
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF)
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Assessment method [1]
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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.
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Timepoint [1]
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Month 6
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Secondary outcome [1]
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Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels
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Assessment method [1]
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The percentage change in SAP at Months 3 and 6 relative to baseline were measured.
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Timepoint [1]
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Baseline, Months 3 and 6
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Secondary outcome [2]
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Percentage of Participants With SAP Within the Normal Range
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Assessment method [2]
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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.
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Timepoint [2]
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Months 3 and 6
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Secondary outcome [3]
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Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [3]
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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.
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Timepoint [3]
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6 months
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Eligibility
Key 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)
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/10/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/03/2011
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Sample size
Target
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Accrual to date
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Final
6
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Brussels
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Canada
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State/province [2]
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Montreal
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Canada
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Quebec
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New Zealand
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State/province [4]
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Auckland
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South Africa
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State/province [5]
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Cape Town
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Spain
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State/province [6]
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Barcelona
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Country [7]
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Spain
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Madrid
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Country [8]
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Spain
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Salamanca
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Country [9]
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Spain
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State/province [9]
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Valencia
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United Kingdom
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State/province [10]
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Nottingham
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Country [11]
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United Kingdom
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State/province [11]
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00740129
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Reid IR, Brown JP, Levitt N, Roman Ivorra JA, Bach...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00740129
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