Clinical trial NCT00740129: Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paget's Disease of the Bone
Keywords: Paget's Disease
Zoledronic acid
Reclast®/Aclasta®
Infusion
Re-treatment
Re-lapse
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Uncontrolled study

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.

Primary outcomes:
measure: Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF)
timeFrame: Month 6
Secondary outcomes:
measure: Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels
timeFrame: Baseline, Months 3 and 6
measure: Percentage of Participants With SAP Within the Normal Range
timeFrame: Months 3 and 6
measure: Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 6 months
Other outcomes:
measure: Collect Information Pertaining to Relapse Diagnosis to Define Retreatment Guidelines for Paget's Disease
timeFrame: 6 months
Locations:
city: Brussels
country: Belgium
facility: Novartis Investigative site
city: Montreal
country: Canada
facility: Novartis Investigative site
city: Quebec
country: Canada
facility: Novartis Investigative site
city: Auckland
country: New Zealand
facility: Novartis Investigative site
city: Cape Town
country: South Africa
facility: Novartis Investigative site
city: Barcelona
country: Spain
facility: Novartis Investigative site
city: Madrid
country: Spain
facility: Novartis Investigative site
city: Salamanca
country: Spain
facility: Novartis Investigative site
city: Valencia
country: Spain
facility: Novartis Investigative site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative site
city: Oxford
country: United Kingdom
facility: Novartis Investigative site
Study officials:
References:
citation: 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.