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Completed

NCT Number: NCT00740129

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative site, Brussels, Belgium

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About this study

Uncontrolled study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Zoledronic acid 5 mg intravenous infusion once

Other names: Reclast®/Aclasta®

Primary outcomes

  1. Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF)

    Time frame: Month 6

    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.

Secondary outcomes

  1. Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels

    Time frame: Baseline, Months 3 and 6

    The percentage change in SAP at Months 3 and 6 relative to baseline were measured.

  2. Percentage of Participants With SAP Within the Normal Range

    Time frame: Months 3 and 6

    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.

  3. Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 6 months

    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.

Other outcomes

  1. Collect Information Pertaining to Relapse Diagnosis to Define Retreatment Guidelines for Paget's Disease

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 22, 2008
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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