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

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ClinicalTrials.gov Identifier: NCT00049452
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

November 12, 2002
January 27, 2003
January 6, 2014
December 2001
Not Provided
Changes in lumbar spine bone mineral density (BMD) at 6 months
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Complete list of historical versions of study NCT00049452 on ClinicalTrials.gov Archive Site
  • Changes in lumbar spine BMD at 12 and 24 months
  • Total hip and femoral neck BMD at 6, 12, and 24 months
  • 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
  • Quality of life as measured by the Short Form-36 instrument at baseline, and at 6 and 12 months
  • Treatment costs
Not Provided
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Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
A Randomized, Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer

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.

OBJECTIVES:

  • 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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
  • Breast Cancer
  • Osteoporosis
Drug: zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Not Provided
August 2008
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 to 50

Sex

  • Female

Menopausal status

  • Premenopausal or perimenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine less than 2 mg/dL

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • 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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00049452
CDR0000258105
CPMC-IRB-14069
NCI-G02-2127
NOVARTIS-CPMC-IRB-14069
Not Provided
Not Provided
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Not Provided
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Dawn Hershman, MD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2007

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