Re-treatment of Participants With Paget's Disease Using Zoledronic Acid

Paget's Disease of the Bone Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740129
• Other study ID #: CZOL446K2418
• Secondary ID: 2008-002898-12
• Status: Completed
• Phase: Phase 4
• Start date: October 21, 2008
• Est. completion date: March 14, 2011

Study information

• Verified date: May 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Uncontrolled study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 14, 2011
• Est. primary completion date: March 14, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases
• Osteitis Deformans
• Paget's Disease of the Bone

Intervention

Drug:
• Zoledronic Acid
Zoledronic acid 5 mg intravenous infusion once

Locations

Country	Name	City	State
Belgium	Novartis Investigative site	Brussels
Canada	Novartis Investigative site	Montreal
Canada	Novartis Investigative site	Quebec
New Zealand	Novartis Investigative site	Auckland
South Africa	Novartis Investigative site	Cape Town
Spain	Novartis Investigative site	Barcelona
Spain	Novartis Investigative site	Madrid
Spain	Novartis Investigative site	Salamanca
Spain	Novartis Investigative site	Valencia
United Kingdom	Novartis Investigative site	Nottingham
United Kingdom	Novartis Investigative site	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Canada,  New Zealand,  South Africa,  Spain,  United Kingdom, 

References & Publications (1)

Reid IR, Brown JP, Levitt N, Román 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Collect Information Pertaining to Relapse Diagnosis to Define Retreatment Guidelines for Paget's Disease		6 months
Primary	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	Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels	The percentage change in SAP at Months 3 and 6 relative to baseline were measured.	Baseline, Months 3 and 6
Secondary	Percentage of Participants With SAP Within the Normal Range	Normalization of 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.	Months 3 and 6
Secondary	Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs)	Adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition that occurred after starting the study drug even if the event was not considered to be related to study drug. TEAEs were defined as AEs that were absent prior to, but occurred after the i.v. infusion of study drug. TEAEs also included those that were present prior to the i.v. study drug infusion (i.e., as part of the extended observation period) but occurred at an increased severity after the i.v. infusion of study drug.	6 months