Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
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
2 other identifiers
interventional
6
6 countries
11
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2008
Typical duration for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2008
CompletedFirst Posted
Study publicly available on registry
August 22, 2008
CompletedStudy Start
First participant enrolled
October 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2011
CompletedResults Posted
Study results publicly available
May 26, 2021
CompletedMay 26, 2021
May 1, 2021
2.4 years
August 21, 2008
May 3, 2021
May 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Month 6
Secondary Outcomes (3)
Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels
Baseline, Months 3 and 6
Percentage of Participants With SAP Within the Normal Range
Months 3 and 6
Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs)
6 months
Other Outcomes (1)
Collect Information Pertaining to Relapse Diagnosis to Define Retreatment Guidelines for Paget's Disease
6 months
Study Arms (1)
Zoledronic Acid 5 mg
EXPERIMENTALParticipants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion.
Interventions
Zoledronic acid 5 mg intravenous infusion once
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Novartis Investigative site
Brussels, Belgium
Novartis Investigative site
Montreal, Canada
Novartis Investigative site
Québec, Canada
Novartis Investigative site
Auckland, New Zealand
Novartis Investigative site
Cape Town, South Africa
Novartis Investigative site
Barcelona, Spain
Novartis Investigative site
Madrid, Spain
Novartis Investigative site
Salamanca, Spain
Novartis Investigative site
Valencia, Spain
Novartis Investigative site
Nottingham, United Kingdom
Novartis Investigative site
Oxford, United Kingdom
Related Publications (1)
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.
PMID: 24422139RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2008
First Posted
August 22, 2008
Study Start
October 21, 2008
Primary Completion
March 14, 2011
Study Completion
March 14, 2011
Last Updated
May 26, 2021
Results First Posted
May 26, 2021
Record last verified: 2021-05