Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00022087
First received: August 10, 2001
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Osteoporosis
Dietary Supplement: calcium salts
Dietary Supplement: cholecalciferol
Drug: zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Bone mineral density in the lumbar spine [ Time Frame: 12 months from randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density in the lumbar spine [ Time Frame: 36 months post randomization ] [ Designated as safety issue: No ]

Enrollment: 439
Study Start Date: December 2001
Study Completion Date: February 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic acid initial tx
Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year
Dietary Supplement: calcium salts
1000 mg PO per day
Dietary Supplement: cholecalciferol
400 IU PO per day
Other Name: Vitamin D
Drug: zoledronic acid
4 mg IV infusion q 3 months, months 1-24 in Zoledronic acid initial tx arm and months 13-36 in calcium + vit D initial tx arm
Other Name: Zometa
Experimental: Calcium + Vit D initial Tx
Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years
Dietary Supplement: calcium salts
1000 mg PO per day
Dietary Supplement: cholecalciferol
400 IU PO per day
Other Name: Vitamin D
Drug: zoledronic acid
4 mg IV infusion q 3 months, months 1-24 in Zoledronic acid initial tx arm and months 13-36 in calcium + vit D initial tx arm
Other Name: Zometa

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast by fine needle aspirate, biopsy (tru-cut, core, stereotactic), lumpectomy, or modified radical mastectomy

    • Stage I-III (any T, any N, M0)
    • Stage IV due solely to supraclavicular node involvement allowed
  • Plan to use adjuvant chemotherapy* with or without adjuvant endocrine therapy*

    • Subsequent adjuvant hormonal therapy with an aromatase inhibitor allowed in women rendered postmenopausal by adjuvant chemotherapy NOTE: *Must be specified prior to study entry
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 40 and over

Sex:

  • Female

Menopausal status:

  • See Disease Characteristics
  • Premenopausal, defined as actively menstruating or last menstrual period occurred within 6 months prior to study entry

    • Prior hysterectomy without bilateral oophorectomy and estradiol and follicle-stimulating hormone within premenopausal range prior to the initiation of chemotherapy allowed

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 3 months since prior adjuvant chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  • See Menopausal status

Other:

  • No other concurrent bisphosphonates
  • No concurrent digoxin
  • No concurrent tetracycline
  • Concurrent neoadjuvant therapy allowed
  • Concurrent enrollment on therapeutic adjuvant clinical trials allowed provided the therapeutic trial does not preclude participation in this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022087

  Hide Study Locations
Locations
United States, California
Arroyo Grande Community Hospital
Arroyo Grande, California, United States, 93420
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
El Camino Hospital
Mountain View, California, United States, 94040
Naval Medical Center - San Diego
San Diego, California, United States, 92134
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
United States, Delaware
Kent General Hospital at Bayhealth Medical Center
Dover, Delaware, United States, 19901
Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
St. Francis Hospital
Wilmington, Delaware, United States, 19805
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States, 33458
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Cancer Research Network, Incorporated
Plantation, Florida, United States, 33324
Cleveland Clinic Florida - Weston
Weston, Florida, United States, 33331
United States, Illinois
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Galesburg Clinic
Galesburg, Illinois, United States, 61401
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Kewanee Hospital
Kewanee, Illinois, United States, 61443
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
McDonough District Hospital
Macomb, Illinois, United States, 61455
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453-2699
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Valley Cancer Center
Spring Valley, Illinois, United States, 61362
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Suniti Medical Corporation
Merrillville, Indiana, United States, 46410
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, United States, 52402
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
United States, Maine
Central Maine Medical Center
Lewiston, Maine, United States, 04240
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Sturdy Memorial Hospital
Attleboro, Massachusetts, United States, 02703
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Faulkner Hospital
Boston, Massachusetts, United States, 02130
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, United States, 01742
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, Minnesota
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Luke's Hospital
Chesterfield, Missouri, United States, 63017
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Missouri Baptist Cancer Center
St. Louis, Missouri, United States, 63131
Missouri Cancer Care, P. C. - Wentzville
Wentzville, Missouri, United States, 63385
United States, Nebraska
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
Oncology Center at St. Joseph Hospital
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Jersey City Medical Center at Liberty Health
Jersey City, New Jersey, United States, 07302
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, United States, 10305
Community General Hospital of Greater Syracuse
Syracuse, New York, United States, 13215
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13057
Faxton Regional Cancer Center
Utica, New York, United States, 13502
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28501
Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
United States, Rhode Island
Miriam Hospital at Lifespan
Providence, Rhode Island, United States, 02906
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Vermont
Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States, 05201
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States, 05701
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, West Virginia
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, United States, 25702
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Charles L. Shapiro, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Shapiro CL, Halabi S, Gibson G, et al.: Effect of zoledronic acid (ZA) on bone mineral density (BMD) in premenopausal women who develop ovarian failure (OF) due to adjuvant chemotherapy (AdC): first results from CALGB trial 79809. [Abstract] J Clin Oncol 26 (Suppl 15): A-512, 2008.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00022087     History of Changes
Other Study ID Numbers: CDR0000068781, U10CA031946, CALGB-79809, NCI-P01-0184
Study First Received: August 10, 2001
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
osteoporosis
stage I breast cancer
stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Zoledronic acid
Calcium, Dietary
Diphosphonates
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014