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Breast CancerPhase 3NCT00022087

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

A Phase 3 study testing calcium salts, cholecalciferol and zoledronic acid in people with Breast Cancer and Osteoporosis, run by Alliance for Clinical Trials in Oncology at 107 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Breast Cancer, Osteoporosis
What is being tested?
calcium salts, cholecalciferol and zoledronic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
439 participants
Where
107 sitesUnited States
Study dates
Dec 2001to Feb 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

107 sites in 1 country.

107 sites in 1 country

United States107 sites

  • Arroyo Grande Community Hospital

    Arroyo Grande, California, 93420

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts, 02703

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Southwestern Vermont Regional Cancer Center

    Bennington, Vermont, 05201

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa, 52722

  • St. Joseph Medical Center

    Bloomington, Illinois, 61701

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Faulkner Hospital

    Boston, Massachusetts, 02130

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Graham Hospital

    Canton, Illinois, 61520

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Bethke Cancer Center at Emerson Hospital

    Concord, Massachusetts, 01742

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Kent General Hospital at Bayhealth Medical Center

    Dover, Delaware, 19901

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Center at Union Hospital

    Elkton MD, Maryland, 21921

  • Eureka Community Hospital

    Eureka, Illinois, 61530

  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Galesburg Clinic

    Galesburg, Illinois, 61401

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois, 61401

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Mason District Hospital

    Havana, Illinois, 62644

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • New Hampshire Oncology-Hematology, PA - Hooksett

    Hooksett, New Hampshire, 03106

  • Hopedale Medical Complex

    Hopedale, Illinois, 61747

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia, 25702

  • Jersey City Medical Center at Liberty Health

    Jersey City, New Jersey, 07302

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • La Grange Memorial Hospital

    La Grange, Illinois, 60525

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • McDonough District Hospital

    Macomb, Illinois, 61455

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • Suniti Medical Corporation

    Merrillville, Indiana, 46410

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Fairview University Medical Center - University Campus

    Minneapolis, Minnesota, 55455

  • El Camino Hospital

    Mountain View, California, 94040

  • Oncology Center at St. Joseph Hospital

    Nashua, New Hampshire, 03060

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • BroMenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center

    Normal, Illinois, 61761

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska, 68114

  • Community Hospital of Ottawa

    Ottawa, Illinois, 61350

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61615

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Community Hospital

    Peru, Illinois, 61354

  • Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina, 28374

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224-1791

  • Cancer Research Network, Incorporated

    Plantation, Florida, 33324

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Miriam Hospital at Lifespan

    Providence, Rhode Island, 02906

  • Community Cancer Center at Rutland Regional Medical Center

    Rutland, Vermont, 05701

  • Naval Medical Center - San Diego

    San Diego, California, 92134

  • Veterans Affairs Medical Center - San Diego

    San Diego, California, 92161

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough

    Scarborough, Maine, 04074

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • St. Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Valley Cancer Center

    Spring Valley, Illinois, 61362

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Nalitt Cancer Institute at Staten Island University Hospital

    Staten Island, New York, 10305

  • CCOP - Hematology-Oncology Associates of Central New York

    Syracuse, New York, 13057

  • Community General Hospital of Greater Syracuse

    Syracuse, New York, 13215

  • Faxton Regional Cancer Center

    Utica, New York, 13502

  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

    Voorhees Township, New Jersey, 08043

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Washington Cancer Institute at Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Missouri Cancer Care, P. C. - Wentzville

    Wentzville, Missouri, 63385

  • Cleveland Clinic Florida - Weston

    Weston, Florida, 33331

  • St. Francis Hospital

    Wilmington, Delaware, 19805

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
calcium salts, cholecalciferol, zoledronic acid
Keywords
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
Medical subject headings
Breast Neoplasms, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • calcium saltsDietary supplement

    1000 mg PO per day

  • cholecalciferolDietary supplement

    Also called Vitamin D

    400 IU PO per day

  • zoledronic acidDrug

    Also called Zometa

    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

Study groups in NCT00022087
Study groupRoleWhat they receive
Zoledronic acid initial txExperimentalZoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year
Receives: Dietary Supplement: calcium salts; Dietary Supplement: cholecalciferol; Drug: zoledronic acid
Calcium + Vit D initial TxExperimentalCalcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years
Receives: Dietary Supplement: calcium salts; Dietary Supplement: cholecalciferol; Drug: zoledronic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone mineral density in the lumbar spine

    Measured: 12 months from randomization

Secondary outcomes (1)

  1. Bone mineral density in the lumbar spine

    Measured: 36 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 2001
  3. Primary completionMar 2007
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022087
Sponsor's protocol ID
CALGB-79809
Other IDs
U10CA031946, CALGB-79809, NCI-P01-0184, CDR0000068781
Status last verified
Jul 2016
First submitted
10 Aug 2001
Last updated
19 Jul 2016
Results posted
No
Data monitoring committee
Yes

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.

  • Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

    PubMed 38979716

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing calcium salts, cholecalciferol and zoledronic acid in people with Breast Cancer and Osteoporosis, run by Alliance for Clinical Trials in Oncology at 107 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone mineral density in the lumbar spine (time frame: 12 months from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00022087, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.

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