Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer

August 18, 2014 updated by: Novartis Pharmaceuticals

A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in in the 2nd Year of Treatment in Patients With Documented Bone Metastases From Breast Cancer

Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

416

Phase

  • Phase 3

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
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center Cancer Research
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Heritage Physicians Group Oncology
      • Springdale, Arkansas, United States, 72764
        • The Center for Chest Care
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc.
      • Campbell, California, United States, 95008
        • South Bay Oncology Hematology Partners
      • Concord, California, United States, 94520
        • Bay Area Cancer Research
      • Fountain Valley, California, United States, 92708
        • Pacific Coast Hem/Onc
      • La Verne, California, United States, 91750
        • Wilshire Oncology Medical Group
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
      • Northridge, California, United States, 91328
        • North Valley Hematology/Oncology Providence Holy Cross Medical
      • Orange, California, United States, 92868
        • Medical Oncology Care Associates
      • Oxnard, California, United States, 93030
        • Ventura County Hematology and Oncology
      • Pomona, California, United States, 91767
        • The Office of Dr. Swarna Chanduri, MD
      • Rancho Mirage, California, United States, 92270
        • Access Clinical Research
      • Rancho Mirage, California, United States, 92270
        • Cancer and Blood of the Desert
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
      • Sylmar, California, United States, 91342
        • University of California at Los Angeles
    • Colorado
      • Denver, Colorado, United States, 80204-4507
        • Denver Health Medical Center CACZ885M2301
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology & Oncology Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
      • Washington, District of Columbia, United States, 20007-2197
        • Georgetown University/Lombardi Cancer Center
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Baptist Cancer Center
      • New Port Richey, Florida, United States, 34652
        • Pasco Hernando Oncology
      • Planatation, Florida, United States, 33324
        • The Office of Dr. Elizabeth Tan-Chiu, MD PA
    • Georgia
      • Lawrenceville, Georgia, United States, 30045
        • Suburban Hematology-Oncology
    • Illinois
      • Chicago, Illinois, United States, 60611
        • NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Healthcare Medical Group
      • Naperville, Illinois, United States, 60540
        • Edward Cancer Center
      • Skokie, Illinois, United States, 60077
        • Midwest Cancer Research Group
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Investigative Clinical Research
      • New Albany, Indiana, United States, 47150
        • Cancer Care Center
      • Terre Haute, Indiana, United States, 47804
        • Associated Physicians & Surgeons Clinic
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Medical Associates Clinic, PC
      • Iowa City, Iowa, United States, 52242-1091
        • University of Iowa Health Care
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates LLP
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Oncology Clinic
      • Witchita, Kansas, United States, 67214-3728
        • Cancer Center of Kansas
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Lung Clinic & Kentucky Sleep Clinic
      • Lexington, Kentucky, United States, 40503
        • Lexington Oncology Associates
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Cabrini Center for Cancer Care
      • Lafayette, Louisiana, United States, 70503
        • Southwest Oncology Associates Ltd.
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Hospital
      • Baltimore, Maryland, United States, 21201-1595
        • Greenbaum Cancer Center
      • Baltimore, Maryland, United States, 21237
        • The Harry and Jeanette Weinberg Cancer Institute at Franklin
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer & Blood Disorders
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Caritas Holy Family Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Clinical Trials Office
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Oncology
      • St. Joseph, Michigan, United States, 49085
        • Oncology Care Associates, PLLC
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • St. Luke's Hospital and Health Network
      • Minneapolis, Minnesota, United States, 55414
        • Fairview Clinical Trial Services
      • Minneapolis, Minnesota, United States, 55455
        • Univ. of Minnesota Cancer Center 420 Delaware St.
      • Robbinsdale, Minnesota, United States, 55422
        • Hubert H. Humphrey Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Capitol Comprehensive Cancer Care Clinic
      • St. Louis, Missouri, United States, 63141
        • The Center for Cancer Care and Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Nebraska Hematology-Oncology PC
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Cancer Centers 2851 North Tenaya Way
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Center for Cancer and Hematologic Disease
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Somerset, New Jersey, United States, 08873
        • Somerset Hematology Oncology Associates
    • New York
      • Armonk, New York, United States, 10504
        • Advanced Oncology Associates
      • Great Neck, New York, United States, 11021
        • Arena Oncology Associates, PC
      • Kingston, New York, United States, 12401
        • Benedictine Hospital
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center
      • Rochester, New York, United States, 14642
        • Jmaes P. Wilmot Cancer Center
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Alamance Regional Medical Cancer Center
      • Concord, North Carolina, United States, 28025
        • Northeast Oncology Associates Suite 250
    • Ohio
      • Barberton, Ohio, United States, 44203
        • Barberton Citizens Hospital
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Mansfield, Ohio, United States, 44907
        • Ohio Cancer Specialists
      • West Worthington, Ohio, United States, 43235
        • Hematology/Oncology Consultants Inc.
      • Wooster, Ohio, United States, 44691
        • Trilogy Cancer Care
    • Oregon
      • Coos Bay, Oregon, United States, 97420
        • Bay Area Hospital - Pharmacy
      • Corvallis, Oregon, United States, 97330
        • The Corvallis Clinic, P.C.
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S Hershey Medical Center
      • Lancaster, Pennsylvania, United States, 17601
        • Lancaster Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • U of Pittsburgh Cancer Institute Magee-Womens Hospital
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Cancer Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Mainline Oncology Hematology Assoc.
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • M. Francisco Gonzalez, MD., FACP
      • Sumter, South Carolina, United States, 29150
        • Santee Hematology/Oncology
    • Texas
      • Houston, Texas, United States, 77031
        • MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street
      • San Antonio, Texas, United States, 78229
        • Cancer Centers of South Texas
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Everett Medical Clinic
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance Seattle Cancer Care Alliance
      • Spokane, Washington, United States, 99202
        • Rockwood Clinic Rockwood Clinic, PS
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses;

Exclusion Criteria:

Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.

Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants).

Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone).

Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization.

Other protocol-defined exclusion criteria may have applied.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zoledronic acid every (q) 4 weeks
Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
Drug: Zoledronic acid
4mg IV
Other Names:
  • ZOL446
  • Zometa
  • Zoledronate
Experimental: Zoledronic acid q 12 weeks
Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
Drug: Zoledronic acid
4mg IV
Other Names:
  • ZOL446
  • Zometa
  • Zoledronate
Drug: Placebo
Placebo to zoledronic acid
Experimental: Placebo / zoledronic acid
Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.
Drug: Zoledronic acid
4mg IV
Other Names:
  • ZOL446
  • Zometa
  • Zoledronate
Drug: Placebo
Placebo to zoledronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)
Time Frame: 52 weeks
An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First SRE
Time Frame: 52 weeks
An SRE was defined as a pathologic bone fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone, or surgery to bone. The time to first individual SRE was defined as the date of randomization to the date of first occurrence of any SRE.
52 weeks
Time to First Individual Type of SRE
Time Frame: 52 weeks
Types of SREs analyzed were pathologic fractures (vertebral and non-vertebral), spinal cord compression, radiation to bone and surgery to bone. The time to first indvidual SRE was defined as the date of randomization to the date of the first occurrence of any individual SRE.
52 weeks
Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score
Time Frame: baseline, 52 weeks
Participants completed a BPI short form which is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on the participant's daily functioning. The participant rates his or her worst, least, average, and current pain intensity, lists current treatments and perceived effectiveness, and rates the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI composite score, which was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now), ranged from 0 (best possible outcome, no pain) to 10 (worst possible outcome, pain as bad as you can imagine). A positive change from baseline indicates worsening.
baseline, 52 weeks
Change From Baseline in Mean Analgesic Score
Time Frame: baseline, 52 weeks
The analgesic score indicates the types of pain medication used. The scores range as follows: 0 = none medication; 1 = minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.); 2 = Tranquilizers, antidepressants, muscle relaxants, and steroids; 3 = Mild narcotics (oxycodone, meperidine, codeine, etc.); and 4 = Strong narcotics (morphine, hydromorphone, etc.). A positive change from baseline indicates worsening.
baseline, 52 weeks
Change From Baseline in Urinary N-telopeptide / Creatinine Ratio
Time Frame: baseline, 48 weeks
Urine samples were collected to obtain n-telopeptide and creatinine values.
baseline, 48 weeks
Change From Baseline in Serum Bone Specific Alkaline Phosphatase
Time Frame: baseline, 48 weeks
Serum samples were collected to obtain bone specific alkaline phosphatase values.
baseline, 48 weeks
Skeletal Morbidity Rate
Time Frame: 52 weeks
An SMR for a patient was defined as the "number of occurrences" of any (or a particular) SRE allowing for only 1 event in any 3-week interval, divided by the "time at risk" in years. The "number of occurrences" and the "time at risk" were counts of SRE and the time from the randomization date. Counting began from randomization in the way that every counted event was followed by a 20-day period during which no SRE was counted, nor was the time counted as "at risk". For example, if a patient had 1 SRE during the study, the "time at risk" was calculated as the total number of days in the study minus the 20-day follow-up period for that SRE. If a patient had no SRE events, the entire study period was counted as "time at risk". This SMR calculation method had the advantage of avoiding multiple counts of possibly interdependent SREs (e.g. having 1 fracture increases the probability of having a subsequent SRE).
52 weeks

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.

General Publications

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

February 1, 2006

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446E2352

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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