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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00740129




Registration number
NCT00740129
Ethics application status
Date submitted
21/08/2008
Date registered
22/08/2008
Date last updated
16/11/2016

Titles & IDs
Public title
Re-treatment of Patients With Paget's Disease Using Zoledronic Acid
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
Secondary ID [1] 0 0
CZOL446K2418
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paget's Disease of the Bone 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic Acid

Other: 1 - Open label, single arm treatment study


Treatment: Drugs: Zoledronic Acid
Zoledronic acid 5 mg intravenous infusion once

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Normalization of total serum alkaline phosphatase within 6 months after a single 5 mg re-treatment dose of zoledronic acid
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Collect information pertaining to relapse diagnosis to define retreatment guidelines for Paget's disease
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Changes in SAP levels relative to baseline
Timepoint [2] 0 0
3 & 6 months
Secondary outcome [3] 0 0
Collect adverse events profile for re-treated patients
Timepoint [3] 0 0
6 months

Eligibility
Key inclusion criteria
- Written Informed Consent

- Patients 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. SAP above ULN, bone scan, worsening
clinical symptoms)
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- A patient previously treated with zoledronic acid who relapsed and was retreated with
anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months

- Bisphosphonate Hypersensitivity

- Patients with suspected/proven metastases at re-treatment

- Calculated creatinine clearance <35 mL/min at screening

- Serum calcium level <2.07 mmol/L at screening

- Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or
hypothyroidism

Other protocol-defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Canada
State/province [2] 0 0
Montreal
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
New Zealand
State/province [4] 0 0
Aukland
Country [5] 0 0
South Africa
State/province [5] 0 0
Cape Town
Country [6] 0 0
Spain
State/province [6] 0 0
Barcelona
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid
Country [8] 0 0
Spain
State/province [8] 0 0
Salamanca
Country [9] 0 0
Spain
State/province [9] 0 0
Valencia
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Nottingham
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate that patients 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 5mg infusion of zoledronic acid.
Trial website
https://clinicaltrials.gov/show/NCT00740129
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications