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
NCT ID: NCT00320710
Last Updated: 2014-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
416 participants
INTERVENTIONAL
2006-02-28
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Zoledronic acid every (q) 4 weeks
Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
Zoledronic acid
4mg IV
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.
Zoledronic acid
4mg IV
Placebo
Placebo to zoledronic acid
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.
Zoledronic acid
4mg IV
Placebo
Placebo to zoledronic acid
Interventions
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Zoledronic acid
4mg IV
Placebo
Placebo to zoledronic acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Providence Alaska Medical Center Cancer Research
Anchorage, Alaska, United States
Heritage Physicians Group Oncology
Hot Springs, Arkansas, United States
The Center for Chest Care
Springdale, Arkansas, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
South Bay Oncology Hematology Partners
Campbell, California, United States
Bay Area Cancer Research
Concord, California, United States
Pacific Coast Hem/Onc
Fountain Valley, California, United States
Wilshire Oncology Medical Group
La Verne, California, United States
Kenmar Research Institute
Los Angeles, California, United States
North Valley Hematology/Oncology Providence Holy Cross Medical
Northridge, California, United States
Medical Oncology Care Associates
Orange, California, United States
Ventura County Hematology and Oncology
Oxnard, California, United States
The Office of Dr. Swarna Chanduri, MD
Pomona, California, United States
Access Clinical Research
Rancho Mirage, California, United States
Cancer and Blood of the Desert
Rancho Mirage, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
University of California at Los Angeles
Sylmar, California, United States
Denver Health Medical Center CACZ885M2301
Denver, Colorado, United States
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, United States
Georgetown University/Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Baptist Cancer Center
Jacksonville, Florida, United States
Pasco Hernando Oncology
New Port Richey, Florida, United States
The Office of Dr. Elizabeth Tan-Chiu, MD PA
Planatation, Florida, United States
Suburban Hematology-Oncology
Lawrenceville, Georgia, United States
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr
Chicago, Illinois, United States
Evanston Northwestern Healthcare Medical Group
Evanston, Illinois, United States
Edward Cancer Center
Naperville, Illinois, United States
Midwest Cancer Research Group
Skokie, Illinois, United States
Investigative Clinical Research
Indianapolis, Indiana, United States
Cancer Care Center
New Albany, Indiana, United States
Associated Physicians & Surgeons Clinic
Terre Haute, Indiana, United States
Medical Associates Clinic, PC
Dubuque, Iowa, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Siouxland Hematology-Oncology Associates LLP
Sioux City, Iowa, United States
Cotton O'Neil Oncology Clinic
Topeka, Kansas, United States
Cancer Center of Kansas
Witchita, Kansas, United States
Kentucky Lung Clinic & Kentucky Sleep Clinic
Hazard, Kentucky, United States
Lexington Oncology Associates
Lexington, Kentucky, United States
Cabrini Center for Cancer Care
Alexandria, Louisiana, United States
Southwest Oncology Associates Ltd.
Lafayette, Louisiana, United States
Greenbaum Cancer Center
Baltimore, Maryland, United States
St. Agnes Hospital
Baltimore, Maryland, United States
The Harry and Jeanette Weinberg Cancer Institute at Franklin
Baltimore, Maryland, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, United States
Frederick Memorial Hospital
Frederick, Maryland, United States
Caritas Holy Family Hospital
Methuen, Massachusetts, United States
University of Michigan Clinical Trials Office
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Henry Ford Hospital Oncology
Detroit, Michigan, United States
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States
St. Luke's Hospital and Health Network
Duluth, Minnesota, United States
Fairview Clinical Trial Services
Minneapolis, Minnesota, United States
Univ. of Minnesota Cancer Center 420 Delaware St.
Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, United States
Jackson Oncology Associates
Jackson, Mississippi, United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States
The Center for Cancer Care and Research
St Louis, Missouri, United States
Nebraska Hematology-Oncology PC
Lincoln, Nebraska, United States
Nevada Cancer Centers 2851 North Tenaya Way
Las Vegas, Nevada, United States
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Somerset Hematology Oncology Associates
Somerset, New Jersey, United States
Advanced Oncology Associates
Armonk, New York, United States
Arena Oncology Associates, PC
Great Neck, New York, United States
Benedictine Hospital
Kingston, New York, United States
Beth Israel Medical Center
New York, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Jmaes P. Wilmot Cancer Center
Rochester, New York, United States
Alamance Regional Medical Cancer Center
Burlington, North Carolina, United States
Northeast Oncology Associates Suite 250
Concord, North Carolina, United States
Barberton Citizens Hospital
Barberton, Ohio, United States
Gabrail Cancer Center
Canton, Ohio, United States
Ohio Cancer Specialists
Mansfield, Ohio, United States
Hematology/Oncology Consultants Inc.
West Worthington, Ohio, United States
Trilogy Cancer Care
Wooster, Ohio, United States
Bay Area Hospital - Pharmacy
Coos Bay, Oregon, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, United States
Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Lancaster Cancer Center
Lancaster, Pennsylvania, United States
U of Pittsburgh Cancer Institute Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Guthrie Cancer Center
Sayre, Pennsylvania, United States
Mainline Oncology Hematology Assoc.
Wynnewood, Pennsylvania, United States
M. Francisco Gonzalez, MD., FACP
Columbia, South Carolina, United States
Santee Hematology/Oncology
Sumter, South Carolina, United States
MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street
Houston, Texas, United States
Cancer Centers of South Texas
San Antonio, Texas, United States
Providence Everett Medical Clinic
Everett, Washington, United States
Seattle Cancer Care Alliance Seattle Cancer Care Alliance
Seattle, Washington, United States
Rockwood Clinic Rockwood Clinic, PS
Spokane, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Hortobagyi GN, Van Poznak C, Harker WG, Gradishar WJ, Chew H, Dakhil SR, Haley BB, Sauter N, Mohanlal R, Zheng M, Lipton A. Continued Treatment Effect of Zoledronic Acid Dosing Every 12 vs 4 Weeks in Women With Breast Cancer Metastatic to Bone: The OPTIMIZE-2 Randomized Clinical Trial. JAMA Oncol. 2017 Jul 1;3(7):906-912. doi: 10.1001/jamaoncol.2016.6316.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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CZOL446E2352
Identifier Type: -
Identifier Source: org_study_id
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