Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year

December 17, 2020 updated by: Novartis Pharmaceuticals

A Stratified, Randomized, Open-label, Multi-center Comparative 2-arm Trial of PK, PD, and Safety of Zoledronic Acid Infusions Administered Monthly vs. Every 3-month, in Multiple Myeloma Patients With Malignant Bone Lesions, and Breast Cancer Patients With Bone Metastasis, Who Have Received 9-12* Doses of Zoledronic Acid Over the Prior Year. (*Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines, the Title Has Not Been Changed)

The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • West Hollywood, California, United States, 90069
        • Oncotherapeutics
    • Colorado
      • Greenwood Village, Colorado, United States
        • Rocky Mountain Cancer Centers RMCC
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Hillman Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112-0550
        • Huntsman Cancer Institute Univ. of Utah
    • Vermont
      • Burlington, Vermont, United States, 05404
        • University of Vermont Fletcher Allen Health Care
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute Virginia Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female between 18-75 years of age
  • Multiple myeloma or breast cancer with bone involvement
  • Treatment with zoledronic acid for bone lesions between 10-15 months prior to entry into study with a total of 9-20 infusions received.

Exclusion Criteria:

  • Current active dental problems or recent (within 8 weeks) or planned dental or jaw surgery
  • Active or uncontrolled infection, liver, or renal disease
  • History of treatment with intravenous bisphosphonates
  • Diagnosis of metabolic bone disorders other than osteoporosis (e.g. Paget's disease)

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zometa q 4 weeks
Drug: Zoledronic acid
Other Names:
  • ZOL446
Active Comparator: Zometa q 12 weeks
Drug: Zoledronic acid
Other Names:
  • ZOL446

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
Time Frame: every four (4) weeks
every four (4) weeks
Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13
Time Frame: every four (4) weeks
every four (4) weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits.
Time Frame: every four (4) weeks
every four (4) weeks
Efficacy outcomes will be measured throughout the study by number and time to skeletal related events (determined by bone surveys and bone scans) as well as the measurement of pain and analgesic scores.
Time Frame: bone survey = every 12 weeks; bone scan = every 24 weeks; pain & analgesic scores = weekly prior to visit 8 (inclusive), every 4 weeks after visit 8
bone survey = every 12 weeks; bone scan = every 24 weeks; pain & analgesic scores = weekly prior to visit 8 (inclusive), every 4 weeks after visit 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

January 19, 2007

First Submitted That Met QC Criteria

January 19, 2007

First Posted (Estimate)

January 22, 2007

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446E2105
  • 2007-004719-73 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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