Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049452
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2002-11-12
Brief Title:
Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Placebo Controlled Trial Of Zoledronic Acid For The Prevention Of Bone Loss In Premenopausal Women With Early Stage Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NOVARTIS-CPMC-IRB-14069 | None | None | None |
| CPMC-IRB-14069 | None | None | None |
| NCI-G02-2127 | None | None | None |