- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00049452
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Connecticut
-
Stamford, Connecticut, United States, 06904
- Carl and Dorothy Bennett Cancer Center at Stamford Hospital
-
-
New Jersey
-
Paramus, New Jersey, United States, 07652-2509
- Valley Hospital - Paramus
-
-
New York
-
New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Changes in lumbar spine bone mineral density (BMD) at 6 months
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Hershman DL, McMahon DJ, Crew KD, Shao T, Cremers S, Brafman L, Awad D, Shane E. Prevention of bone loss by zoledronic acid in premenopausal women undergoing adjuvant chemotherapy persist up to one year following discontinuing treatment. J Clin Endocrinol Metab. 2010 Feb;95(2):559-66. doi: 10.1210/jc.2009-1366. Epub 2009 Dec 18.
- Hershman DL, McMahon DJ, Crew KD, Cremers S, Irani D, Cucchiara G, Brafman L, Shane E. Zoledronic acid prevents bone loss in premenopausal women undergoing adjuvant chemotherapy for early-stage breast cancer. J Clin Oncol. 2008 Oct 10;26(29):4739-45. doi: 10.1200/JCO.2008.16.4707. Epub 2008 Aug 18.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000258105
- CPMC-IRB-14069
- NCI-G02-2127
- NOVARTIS-CPMC-IRB-14069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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