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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049452
First received: November 12, 2002
Last updated: January 3, 2014
Last verified: April 2007
  Purpose

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 Intervention Phase
Breast Cancer
Osteoporosis
Drug: zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 120
Study Start Date: December 2001
Study Completion Date: August 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049452

Locations
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
Investigators
Study Chair: Dawn Hershman, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00049452     History of Changes
Other Study ID Numbers: CDR0000258105, CPMC-IRB-14069, NCI-G02-2127, NOVARTIS-CPMC-IRB-14069
Study First Received: November 12, 2002
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
osteoporosis
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014