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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03859895
Registration number
NCT03859895
Ethics application status
Date submitted
31/01/2019
Date registered
1/03/2019
Titles & IDs
Public title
Zoledronate In the Prevention of Paget's Disease: Long Term Extension
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Scientific title
Zoledronate In the Prevention of Paget's Disease: Long Term Extension
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Secondary ID [1]
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245197
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Secondary ID [2]
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AC18051
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Universal Trial Number (UTN)
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Trial acronym
ZiPP-LTE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Paget Disease
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Observational (without bone scan) - Former Observational Arm participants of the ZiPP trial.
Observational (with bone scan) - Former Interventional Arm participants of the ZiPP trial.
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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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Primary Endpoint (former ZiPP interventional arm): The proportion of patients that develop PDB-like bone lesions
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Assessment method [1]
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The proportion of patients in each of the randomisation groups that develop PDB-like bone lesions by the end of study assessed by radionuclide bone scan.
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Timepoint [1]
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5 year time-point
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Primary outcome [2]
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Primary Endpoint (former ZiPP observational arm): proportion of individuals that develop abnormalities suggestive of PDB
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Assessment method [2]
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The primary endpoint will be to evaluate the proportion of individuals that develop biochemical or clinical abnormalities suggestive of PDB over a the 10-year duration of follow up.
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Timepoint [2]
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During follow-up period
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Secondary outcome [1]
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Secondary Endpoint (former ZiPP interventional arm): Differences between ZiPP trial treatment and placebo groups with regard to the number of new bone lesions assessed by radionuclide bone scan.
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Assessment method [1]
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Timepoint [1]
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5 year time-point
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Secondary outcome [2]
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Secondary Endpoint (former ZiPP interventional arm): Evaluate differences between ZiPP treatment and placebo groups for change in bone lesion activity by semi-quantitative analysis of radionuclide bone scans (method described by Patel et al (1995)).
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Assessment method [2]
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Timepoint [2]
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5 year time-point
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Secondary outcome [3]
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Secondary Endpoint (former ZiPP interventional arm): Differences between ZiPP trial treatment and placebo groups with regard to SF36 (36-Item Short Form Survey) scores.
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Assessment method [3]
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Timepoint [3]
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5 year time-point
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Secondary outcome [4]
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Secondary Endpoint (former ZiPP interventional arm): Differences between ZiPP trial treatment and placebo groups with regard to HAQ (Health Assessment Questionnaire) scores.
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Assessment method [4]
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Timepoint [4]
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5 year time-point
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Secondary outcome [5]
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Secondary Endpoint (former ZiPP interventional arm): Differences between ZiPP trial treatment and placebo groups with regard to EQ5D (EuroQol five dimension scale) scores.
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Assessment method [5]
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Timepoint [5]
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5 year time-point
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Secondary outcome [6]
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Secondary Endpoint (former ZiPP interventional arm): Differences between ZiPP trial treatment and placebo groups with regard to IPAQ (International Physical Activity Questionnaire) scores.
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Assessment method [6]
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Timepoint [6]
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5 year time-point
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Secondary outcome [7]
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Secondary Endpoint (former ZiPP interventional arm): Differences between ZiPP trial treatment and placebo groups with regard to BPI (Brief Pain Inventory Scale) scores.
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Assessment method [7]
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Timepoint [7]
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5 year time-point
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Secondary outcome [8]
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Secondary Endpoint (former ZiPP interventional arm): Differences between ZiPP trial treatment and placebo groups with regard to development of PDB-related skeletal events (PRSE).
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Assessment method [8]
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Defined as new bone lesions thought to be due to PDB on imaging OR complications of PDB such as pathological fractures, bone deformity, deafness, and joint replacement surgery OR administration of treatment for PDB because of pain localised to an affected site in a patient with metabolically active disease.
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Timepoint [8]
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5 year time-point
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Secondary outcome [9]
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Secondary Endpoint (former ZiPP observational arm): Health-related quality of life in ZiPP trial observational arm participants assessed using EQ5D.
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Assessment method [9]
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Timepoint [9]
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5 year time-point
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Secondary outcome [10]
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Secondary Endpoint (former ZiPP observational arm): Health-related quality of life in ZiPP trial observational arm participants assessed using SF36.
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Assessment method [10]
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Timepoint [10]
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5 year time-point
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Secondary outcome [11]
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Secondary Endpoint (former ZiPP observational arm): Health-related quality of life in ZiPP trial observational arm participants assessed using BPI.
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Assessment method [11]
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Timepoint [11]
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5 year time-point
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Secondary outcome [12]
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Secondary Endpoint (former ZiPP observational arm): Health-related quality of life in ZiPP trial observational arm participants assessed using HAQ.
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Assessment method [12]
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Timepoint [12]
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5 year time-point
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Secondary outcome [13]
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Secondary Endpoint (former ZiPP observational arm): Health-related quality of life in ZiPP trial observational arm participants assessed using IPAQ.
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Assessment method [13]
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Timepoint [13]
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5 year time-point
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Secondary outcome [14]
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Secondary Endpoint (former ZiPP observational arm): Pain in ZiPP trial observational arm participants assessed using EQ5D.
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Assessment method [14]
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Timepoint [14]
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5 year time-point
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Secondary outcome [15]
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Secondary Endpoint (former ZiPP observational arm): Pain in ZiPP trial observational arm participants assessed using SF36.
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Assessment method [15]
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Timepoint [15]
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5 year time-point
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Secondary outcome [16]
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Secondary Endpoint (former ZiPP observational arm): Pain in ZiPP trial observational arm participants assessed using BPI.
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Assessment method [16]
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Timepoint [16]
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5 year time-point
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Secondary outcome [17]
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Secondary Endpoint (former ZiPP observational arm): Anxiety in ZiPP trial observational arm participants assessed using EQ5D.
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Assessment method [17]
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Timepoint [17]
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5 year time-point
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Secondary outcome [18]
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Secondary Endpoint (former ZiPP observational arm): Anxiety in ZiPP trial observational arm participants assessed using SF36.
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Assessment method [18]
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Timepoint [18]
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5 year time-point
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Secondary outcome [19]
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Secondary Endpoint (former ZiPP observational arm): Depression in ZiPP trial observational arm participants assessed using SF-36.
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Assessment method [19]
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Timepoint [19]
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5 year time-point
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Secondary outcome [20]
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Secondary Endpoint (former ZiPP observational arm): Depression in ZiPP trial observational arm participants assessed using BPI.
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Assessment method [20]
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Timepoint [20]
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5 year time-point
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Secondary outcome [21]
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Secondary Endpoint (former ZiPP observational arm): Depression in ZiPP trial observational arm participants assessed using EQ5D.
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Assessment method [21]
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Timepoint [21]
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5 year time-point
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Eligibility
Key inclusion criteria
* Subject that participated in ZiPP
* Participant willing and able to consent and comply with the study protocol.
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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
* Unable or unwilling to provide informed consent
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
5/04/2019
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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
1/12/2024
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Actual
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Sample size
Target
287
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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University Hospital Geelong - Geelong
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Recruitment hospital [2]
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Sir Charles Gardner Hospital - Nedlands
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Recruitment hospital [3]
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Royal Newcastle Centre - Newcastle
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Recruitment hospital [4]
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University of Sydney - Sydney
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Recruitment hospital [5]
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University of Queensland - Toowoomba
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Recruitment postcode(s) [1]
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3220 - Geelong
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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NSW 2305 - Newcastle
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Recruitment postcode(s) [4]
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- Sydney
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Recruitment postcode(s) [5]
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QLD 4350 - Toowoomba
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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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Country [2]
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Ireland
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State/province [2]
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Dublin
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Country [3]
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Italy
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State/province [3]
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Florence
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Country [4]
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Italy
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State/province [4]
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Siena
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Country [5]
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Italy
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State/province [5]
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Turin
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Country [6]
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New Zealand
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State/province [6]
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Auckland
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Country [7]
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New Zealand
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State/province [7]
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Christchurch
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Country [8]
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Spain
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State/province [8]
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Barcelona
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Country [9]
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Spain
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State/province [9]
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Salamanca
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Country [10]
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United Kingdom
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State/province [10]
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England
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Country [11]
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United Kingdom
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State/province [11]
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Scotland
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Country [12]
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United Kingdom
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State/province [12]
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Wales
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Edinburgh
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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European Research Council
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Paget's disease of the bone (PDB) is a metabolic bone disorder which in some individuals can cause pain, bone deformity, arthritis and deafness, although in many patients it does not cause symptoms. Paget's disease has a strong genetic component and SQSTM1 is the most important susceptibility gene. People who inherit mutations in SQSTM1 have a high risk of developing PDB later in life. This study is an extension of the ZiPP (Zoledronate in the Prevention of Paget's) study which was is randomised trial currently in progress to determine if the bisphosphonate zoledronic acid (ZA) can prevent or delay the development of PDB-like bone lesions compared with a dummy treatment (placebo) in people who inherit SQSMT1 gene mutations. Although the ZiPP study will provide information on whether early ZA treatment can favourably influence bone lesion development the significance of this to the patient in terms of symptoms is unclear as yet. The aim of the extension study is to keep these individuals under surveillance for any symptoms or signs of PDB over a further 5 year period and to evaluate if there has been any progression of PDB-like lesions by bone scan at the end of this period.
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Trial website
https://clinicaltrials.gov/study/NCT03859895
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stuart Ralston, Prof
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Address
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Univeristy of Edinburgh
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03859895