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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
2008-002898-12
Secondary ID [2] 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

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF)
Timepoint [1] 0 0
Month 6
Secondary outcome [1] 0 0
Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels
Timepoint [1] 0 0
Baseline, Months 3 and 6
Secondary outcome [2] 0 0
Percentage of Participants With SAP Within the Normal Range
Timepoint [2] 0 0
Months 3 and 6
Secondary outcome [3] 0 0
Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs)
Timepoint [3] 0 0
6 months

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)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
21/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/03/2011
Sample size
Target
Accrual to date
Final
6
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
Auckland
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 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.
Trial website
https://clinicaltrials.gov/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00740129