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

August 10, 2001
September 26, 2013
December 2001
March 2007   (final data collection date for primary outcome measure)
Bone mineral density in the lumbar spine [ Time Frame: 12 months from randomization ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00022087 on ClinicalTrials.gov Archive Site
Bone mineral density in the lumbar spine [ Time Frame: 36 months post randomization ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Osteoporosis
  • 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: Zoledronic acid initial tx
    Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year
    Interventions:
    • Dietary Supplement: calcium salts
    • Dietary Supplement: cholecalciferol
    • Drug: zoledronic acid
  • Experimental: Calcium + Vit D initial Tx
    Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years
    Interventions:
    • Dietary Supplement: calcium salts
    • Dietary Supplement: cholecalciferol
    • Drug: zoledronic acid
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
439
February 2009
March 2007   (final data collection date for primary outcome measure)

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
Female
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022087
CDR0000068781, U10CA031946, CALGB-79809, NCI-P01-0184
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Charles L. Shapiro, MD Ohio State University Comprehensive Cancer Center
Alliance for Clinical Trials in Oncology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP