Status:
COMPLETED
Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Paget's Disease of the Bone
Eligibility:
All Genders
Phase:
PHASE4
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 CZOL446K...
Detailed Description
Uncontrolled study
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
October 21 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00740129
Start Date
October 21 2008
End Date
March 14 2011
Last Update
May 26 2021
Active Locations (11)
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1
Novartis Investigative site
Brussels, Belgium
2
Novartis Investigative site
Montreal, Canada
3
Novartis Investigative site
Québec, Canada
4
Novartis Investigative site
Auckland, New Zealand