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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

Primary Purpose

Multiple Myeloma, Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, breast cancer, zoledronic acid, pharmacokinetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncotherapeutics
  • Rocky Mountain Cancer Centers RMCC
  • Norwalk Hospital
  • Hillman Cancer Center
  • Huntsman Cancer Institute Univ. of Utah
  • University of Vermont Fletcher Allen Health Care
  • Virginia Cancer Institute Virginia Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zometa q 4 weeks

Zometa q 12 weeks

Arm Description

Outcomes

Primary Outcome Measures

Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13

Secondary Outcome Measures

Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits.
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.

Full Information

First Posted
January 19, 2007
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00424983
Brief Title
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
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Breast Cancer
Keywords
Multiple myeloma, breast cancer, zoledronic acid, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zometa q 4 weeks
Arm Type
Experimental
Arm Title
Zometa q 12 weeks
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
ZOL446
Primary Outcome Measure Information:
Title
Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
Time Frame
every four (4) weeks
Title
Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13
Time Frame
every four (4) weeks
Secondary Outcome Measure Information:
Title
Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits.
Time Frame
every four (4) weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Oncotherapeutics
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Rocky Mountain Cancer Centers RMCC
City
Greenwood Village
State/Province
Colorado
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Huntsman Cancer Institute Univ. of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-0550
Country
United States
Facility Name
University of Vermont Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05404
Country
United States
Facility Name
Virginia Cancer Institute Virginia Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novartisclinicaltrials.com/TrialConnectWeb/home.nov
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7464
Description
Results for CZOL446E2105 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

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

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