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Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049452
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in premenopausal women who are receiving adjuvant chemotherapy after undergoing surgery for early stage breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate in preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for early stage breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Osteoporosis Drug: zoledronic acid Phase 3

Detailed Description:


  • Compare the changes in bone mineral density (BMD) and bone turnover that occur in premenopausal women with resected early stage breast cancer during and after 6 months of adjuvant chemotherapy.
  • Determine the factors that predict bone loss during chemotherapy, particularly induction of amenorrhea, type of chemotherapeutic regimen, glucocorticoid exposure, and baseline BMD, in these patients.
  • Determine whether zoledronate prevents bone loss in these patients when given during and after adjuvant chemotherapy.
  • Determine the effect of zoledronate on markers of bone turnover in these patients during and after adjuvant chemotherapy.
  • Determine whether the effect on markers of bone turnover predicts response to zoledronate in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative), progesterone receptor status (positive vs negative), and adjuvant chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive zoledronate IV over 15 minutes on day 1.
  • Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, treatment repeats every 3 months for up to 4 courses in the absence of disease progression. Patients also receive calcium and cholecalciferol (vitamin D) supplements daily.

Quality of life is assessed at baseline and at 6 and 12 months.

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: A Randomized, Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer
Study Start Date : December 2001
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Changes in lumbar spine bone mineral density (BMD) at 6 months

Secondary Outcome Measures :
  1. Changes in lumbar spine BMD at 12 and 24 months
  2. Total hip and femoral neck BMD at 6, 12, and 24 months
  3. Serum markers of bone turnover (osteocalcin, bone-specific alkaline phosphatase, and cross-linked C-telopeptide of type 1 collagen levels) measured every 6 weeks for 6 months, and at 9 and 12 months
  4. Quality of life as measured by the Short Form-36 instrument at baseline, and at 6 and 12 months
  5. Treatment costs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of localized breast cancer

    • Stage I or II (T1-3, N0-2, M0)
  • Planned adjuvant chemotherapy (after surgery) of at least 6 months in duration
  • Hormone receptor status:

    • Estrogen receptor and progesterone receptor status known



  • 18 to 50


  • Female

Menopausal status

  • Premenopausal or perimenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Creatinine less than 2 mg/dL


  • No T score of less than 2.0 on bone mineral density (BMD)
  • No fragility fracture
  • No lumbar spine anatomy that would preclude accurate BMD measurement of a minimum of 3 lumbar vertebrae
  • Not pregnant


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • No concurrent radiotherapy


  • See Disease Characteristics


  • At least 1 month since prior calcitonin
  • At least 12 months since prior bisphosphonates given for more than 1 month duration
  • No concurrent fluoride therapy (10 mg/day or more)
  • No concurrent enrollment in another experimental drug study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00049452

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United States, Connecticut
Carl and Dorothy Bennett Cancer Center at Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, New Jersey
Valley Hospital - Paramus
Paramus, New Jersey, United States, 07652-2509
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
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Study Chair: Dawn Hershman, MD Herbert Irving Comprehensive Cancer Center
Publications of Results:
Layout table for additonal information Identifier: NCT00049452    
Other Study ID Numbers: CDR0000258105
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: April 2007
Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs