Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer
- Conditions
- OsteoporosisBreast Cancer
- Interventions
- Registration Number
- NCT00022087
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss.
PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.
- Detailed Description
OBJECTIVES:
* Compare the bone mineral density in the lumbar spine after 12 and 36 months of therapy with zoledronate, calcium, and cholecalciferol (vitamin D) in women with breast cancer receiving adjuvant chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to intent to treat with tamoxifen (yes vs no) and node status (negative vs positive vs unknown \[for patients receiving neoadjuvant therapy\]). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Beginning on the first day of adjuvant chemotherapy (or within 3 months after the first day), patients receive zoledronate IV over at least 15 minutes once every 3 months during months 1-24 and oral calcium and oral cholecalciferol (vitamin D) daily during months 1-36.
* Arm II: Beginning on the first day of adjuvant chemotherapy (or within 3 months after the first day), patients receive oral calcium and oral vitamin D daily during months 1-36 and zoledronate IV over at least 15 minutes once every 3 months during months 13-36.
PROJECTED ACCRUAL: Approximately 400 patients (200 per treatment arm) will be accrued for this study within 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 439
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calcium + Vit D initial Tx zoledronic acid Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years Zoledronic acid initial tx cholecalciferol Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year Calcium + Vit D initial Tx cholecalciferol Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years Calcium + Vit D initial Tx calcium salts Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years Zoledronic acid initial tx calcium salts Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year Zoledronic acid initial tx zoledronic acid Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year
- Primary Outcome Measures
Name Time Method Bone mineral density in the lumbar spine 12 months from randomization
- Secondary Outcome Measures
Name Time Method Bone mineral density in the lumbar spine 36 months post randomization
Trial Locations
- Locations (107)
Kent General Hospital at Bayhealth Medical Center
🇺🇸Dover, Delaware, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Suniti Medical Corporation
🇺🇸Merrillville, Indiana, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
🇺🇸Scarborough, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸Syracuse, New York, United States
Missouri Baptist Cancer Center
🇺🇸St. Louis, Missouri, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Faulkner Hospital
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Lowell General Hospital
🇺🇸Lowell, Massachusetts, United States
Jersey City Medical Center at Liberty Health
🇺🇸Jersey City, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
🇺🇸Voorhees, New Jersey, United States
Nalitt Cancer Institute at Staten Island University Hospital
🇺🇸Staten Island, New York, United States
Community General Hospital of Greater Syracuse
🇺🇸Syracuse, New York, United States
Faxton Regional Cancer Center
🇺🇸Utica, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Lenoir Memorial Cancer Center
🇺🇸Kinston, North Carolina, United States
Moore Regional Community Hospital Comprehensive Cancer Center
🇺🇸Pinehurst, North Carolina, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Women and Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Miriam Hospital at Lifespan
🇺🇸Providence, Rhode Island, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Methodist Cancer Center at Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
Community Cancer Center at Rutland Regional Medical Center
🇺🇸Rutland, Vermont, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Iowa Blood and Cancer Care
🇺🇸Cedar Rapids, Iowa, United States
Cancer Research Network, Incorporated
🇺🇸Plantation, Florida, United States
Cleveland Clinic Florida - Weston
🇺🇸Weston, Florida, United States
Washington Cancer Institute at Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Arroyo Grande Community Hospital
🇺🇸Arroyo Grande, California, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Sturdy Memorial Hospital
🇺🇸Attleboro, Massachusetts, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
La Grange Memorial Hospital
🇺🇸La Grange, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Central Maine Medical Center
🇺🇸Lewiston, Maine, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
St. Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Bethke Cancer Center at Emerson Hospital
🇺🇸Concord, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St Louis, Missouri, United States
Missouri Cancer Care, P. C. - Wentzville
🇺🇸Wentzville, Missouri, United States
Union Hospital Cancer Center at Union Hospital
🇺🇸Elkton MD, Maryland, United States
Saint Luke's Hospital
🇺🇸Chesterfield, Missouri, United States
Fairview University Medical Center - University Campus
🇺🇸Minneapolis, Minnesota, United States
Lakes Region General Hospital
🇺🇸Laconia, New Hampshire, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Oncology Center at St. Joseph Hospital
🇺🇸Nashua, New Hampshire, United States
St. Francis Hospital
🇺🇸Wilmington, Delaware, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Elliot Regional Cancer Center
🇺🇸Manchester, New Hampshire, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Mountainview Medical
🇺🇸Berlin, Vermont, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Southwestern Vermont Regional Cancer Center
🇺🇸Bennington, Vermont, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States