Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For 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 Design:||Allocation: Randomized
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|
- Changes in lumbar spine bone mineral density (BMD) at 6 months
- 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
|Study Start Date:||December 2001|
|Study Completion Date:||August 2008|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049452
|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|
|Study Chair:||Dawn Hershman, MD||Herbert Irving Comprehensive Cancer Center|