Phase 4
Completed N=6
Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
Paget's Disease of the Bone
Source: ClinicalTrials.gov NCT00740129 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF) — 83.3 Percentage of Participants
◆ Published Evidence
Emerging
18citations · ~1 / year
Re-treatment of relapsed Paget's disease of bone with zoledronic acid: results from an open-label study.
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.
Linked Publications
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Re-treatment of relapsed Paget's disease of bone with zoledronic acid: results from an open-label study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF) |
83.3 | — |
| SECONDARY Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels |
-53.12; -49.51 | — |
| SECONDARY Percentage of Participants With SAP Within the Normal Range |
100.0; 83.3 | — |
| SECONDARY Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs) |
1 | — |
Eligibility Criteria
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)
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.
Data sourced from ClinicalTrials.gov (NCT00740129) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.