A Randomized, Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer
- 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
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Changes in lumbar spine bone mineral density (BMD) at 6 months
Dawn Hershman, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|
|Carl and Dorothy Bennett Cancer Center at Stamford Hospital||Stamford, Connecticut 06904|
|Valley Hospital - Paramus||Paramus, New Jersey 07652-2509|