Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer
- Conditions
- OsteoporosisBreast Cancer
- Interventions
- Registration Number
- NCT00022087
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss.
PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.
- Detailed Description
OBJECTIVES:
* Compare the bone mineral density in the lumbar spine after 12 and 36 months of therapy with zoledronate, calcium, and cholecalciferol (vitamin D) in women with breast cancer receiving adjuvant chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to intent to treat with tamoxifen (yes vs no) and node status (negative vs positive vs unknown \[for patients receiving neoadjuvant therapy\]). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Beginning on the first day of adjuvant chemotherapy (or within 3 months after the first day), patients receive zoledronate IV over at least 15 minutes once every 3 months during months 1-24 and oral calcium and oral cholecalciferol (vitamin D) daily during months 1-36.
* Arm II: Beginning on the first day of adjuvant chemotherapy (or within 3 months after the first day), patients receive oral calcium and oral vitamin D daily during months 1-36 and zoledronate IV over at least 15 minutes once every 3 months during months 13-36.
PROJECTED ACCRUAL: Approximately 400 patients (200 per treatment arm) will be accrued for this study within 24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 439
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Calcium + Vit D initial Tx zoledronic acid Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years Zoledronic acid initial tx cholecalciferol Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year Calcium + Vit D initial Tx cholecalciferol Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years Calcium + Vit D initial Tx calcium salts Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years Zoledronic acid initial tx calcium salts Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year Zoledronic acid initial tx zoledronic acid Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year
- Primary Outcome Measures
Name Time Method Bone mineral density in the lumbar spine 12 months from randomization
- Secondary Outcome Measures
Name Time Method Bone mineral density in the lumbar spine 36 months post randomization
Trial Locations
- Locations (107)
Arroyo Grande Community Hospital
🇺🇸Arroyo Grande, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Kent General Hospital at Bayhealth Medical Center
🇺🇸Dover, Delaware, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
St. Francis Hospital
🇺🇸Wilmington, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Scroll for more (97 remaining)Arroyo Grande Community Hospital🇺🇸Arroyo Grande, California, United States