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
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
1 other identifier
interventional
416
1 country
92
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Feb 2006
Typical duration for phase_3 breast-cancer
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 28, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
August 4, 2014
CompletedAugust 22, 2014
August 1, 2014
7.4 years
April 28, 2006
July 8, 2014
August 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)
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 Outcomes (7)
Time to First SRE
52 weeks
Time to First Individual Type of SRE
52 weeks
Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score
baseline, 52 weeks
Change From Baseline in Mean Analgesic Score
baseline, 52 weeks
Change From Baseline in Urinary N-telopeptide / Creatinine Ratio
baseline, 48 weeks
- +2 more secondary outcomes
Study Arms (3)
Zoledronic acid every (q) 4 weeks
EXPERIMENTALParticipants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
Zoledronic acid q 12 weeks
EXPERIMENTALParticipants 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.
Placebo / zoledronic acid
EXPERIMENTALParticipants 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.
Interventions
4mg IV
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
Providence Alaska Medical Center Cancer Research
Anchorage, Alaska, 99508, United States
Heritage Physicians Group Oncology
Hot Springs, Arkansas, 71913, United States
The Center for Chest Care
Springdale, Arkansas, 72764, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
South Bay Oncology Hematology Partners
Campbell, California, 95008, United States
Bay Area Cancer Research
Concord, California, 94520, United States
Pacific Coast Hem/Onc
Fountain Valley, California, 92708, United States
Wilshire Oncology Medical Group
La Verne, California, 91750, United States
Kenmar Research Institute
Los Angeles, California, 90057, United States
North Valley Hematology/Oncology Providence Holy Cross Medical
Northridge, California, 91328, United States
Medical Oncology Care Associates
Orange, California, 92868, United States
Ventura County Hematology and Oncology
Oxnard, California, 93030, United States
The Office of Dr. Swarna Chanduri, MD
Pomona, California, 91767, United States
Access Clinical Research
Rancho Mirage, California, 92270, United States
Cancer and Blood of the Desert
Rancho Mirage, California, 92270, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
University of California at Los Angeles
Sylmar, California, 91342, United States
Denver Health Medical Center CACZ885M2301
Denver, Colorado, 80204-4507, United States
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, 06360, United States
Georgetown University/Lombardi Cancer Center
Washington D.C., District of Columbia, 20007-2197, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Baptist Cancer Center
Jacksonville, Florida, 32209, United States
Pasco Hernando Oncology
New Port Richey, Florida, 34652, United States
The Office of Dr. Elizabeth Tan-Chiu, MD PA
Planatation, Florida, 33324, United States
Suburban Hematology-Oncology
Lawrenceville, Georgia, 30045, United States
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr
Chicago, Illinois, 60611, United States
Evanston Northwestern Healthcare Medical Group
Evanston, Illinois, 60201, United States
Edward Cancer Center
Naperville, Illinois, 60540, United States
Midwest Cancer Research Group
Skokie, Illinois, 60077, United States
Investigative Clinical Research
Indianapolis, Indiana, 46254, United States
Cancer Care Center
New Albany, Indiana, 47150, United States
Associated Physicians & Surgeons Clinic
Terre Haute, Indiana, 47804, United States
Medical Associates Clinic, PC
Dubuque, Iowa, 52001, United States
University of Iowa Health Care
Iowa City, Iowa, 52242-1091, United States
Siouxland Hematology-Oncology Associates LLP
Sioux City, Iowa, 51101, United States
Cotton O'Neil Oncology Clinic
Topeka, Kansas, 66606, United States
Cancer Center of Kansas
Witchita, Kansas, 67214-3728, United States
Kentucky Lung Clinic & Kentucky Sleep Clinic
Hazard, Kentucky, 41701, United States
Lexington Oncology Associates
Lexington, Kentucky, 40503, United States
Cabrini Center for Cancer Care
Alexandria, Louisiana, 71301, United States
Southwest Oncology Associates Ltd.
Lafayette, Louisiana, 70503, United States
Greenbaum Cancer Center
Baltimore, Maryland, 21201-1595, United States
St. Agnes Hospital
Baltimore, Maryland, 21229, United States
The Harry and Jeanette Weinberg Cancer Institute at Franklin
Baltimore, Maryland, 21237, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Caritas Holy Family Hospital
Methuen, Massachusetts, 01844, United States
University of Michigan Clinical Trials Office
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Henry Ford Hospital Oncology
Detroit, Michigan, 48202, United States
Oncology Care Associates, PLLC
Saint Joseph, Michigan, 49085, United States
St. Luke's Hospital and Health Network
Duluth, Minnesota, 55805, United States
Fairview Clinical Trial Services
Minneapolis, Minnesota, 55414, United States
Univ. of Minnesota Cancer Center 420 Delaware St.
Minneapolis, Minnesota, 55455, United States
Hubert H. Humphrey Cancer Center
Robbinsdale, Minnesota, 55422, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109, United States
The Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Nebraska Hematology-Oncology PC
Lincoln, Nebraska, 68506, United States
Nevada Cancer Centers 2851 North Tenaya Way
Las Vegas, Nevada, 89109, United States
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Somerset Hematology Oncology Associates
Somerset, New Jersey, 08873, United States
Advanced Oncology Associates
Armonk, New York, 10504, United States
Arena Oncology Associates, PC
Great Neck, New York, 11021, United States
Benedictine Hospital
Kingston, New York, 12401, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Jmaes P. Wilmot Cancer Center
Rochester, New York, 14642, United States
Alamance Regional Medical Cancer Center
Burlington, North Carolina, 27215, United States
Northeast Oncology Associates Suite 250
Concord, North Carolina, 28025, United States
Barberton Citizens Hospital
Barberton, Ohio, 44203, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Ohio Cancer Specialists
Mansfield, Ohio, 44907, United States
Hematology/Oncology Consultants Inc.
West Worthington, Ohio, 43235, United States
Trilogy Cancer Care
Wooster, Ohio, 44691, United States
Bay Area Hospital - Pharmacy
Coos Bay, Oregon, 97420, United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330, United States
Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Lancaster Cancer Center
Lancaster, Pennsylvania, 17601, United States
U of Pittsburgh Cancer Institute Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Guthrie Cancer Center
Sayre, Pennsylvania, 18840, United States
Mainline Oncology Hematology Assoc.
Wynnewood, Pennsylvania, 19096, United States
M. Francisco Gonzalez, MD., FACP
Columbia, South Carolina, 29203, United States
Santee Hematology/Oncology
Sumter, South Carolina, 29150, United States
MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street
Houston, Texas, 77031, United States
Cancer Centers of South Texas
San Antonio, Texas, 78229, United States
Providence Everett Medical Clinic
Everett, Washington, 98201, United States
Seattle Cancer Care Alliance Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Rockwood Clinic Rockwood Clinic, PS
Spokane, Washington, 99202, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 28125763DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2006
First Posted
May 3, 2006
Study Start
February 1, 2006
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
August 22, 2014
Results First Posted
August 4, 2014
Record last verified: 2014-08