Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114270
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2005-06-13
Brief Title:
Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density
Sponsor:
University of Virginia
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2006-04
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 Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back Estrogen can cause the growth of breast cancer cells Hormone therapy using letrozole may prevent breast cancer by lowering the amount of estrogen the body makes Zoledronate may prevent bone loss caused by letrozole Giving letrozole together with zoledronate may prevent breast cancer and reduce bone loss
PURPOSE This randomized clinical trial is studying letrozole and zoledronate to see how well they work compared to letrozole and placebo or placebo alone in treating healthy postmenopausal women with high breast density
PURPOSE This randomized clinical trial is studying letrozole and zoledronate to see how well they work compared to letrozole and placebo or placebo alone in treating healthy postmenopausal women with high breast density
Detailed Description:
OBJECTIVES
Primary
Compare the percent change in breast density in healthy postmenopausal women with high breast density treated with placebo only vs letrozole and placebo vs letrozole and zoledronate
Compare the percent change in biochemical markers of bone turnover in participants treated with these regimens
Secondary
Compare the bone density in participants treated with these regimens
Compare growth hormone release and insulin-like growth factor levels in participants treated with these regimens
Compare the incidence and severity of adverse events in participants treated with these regimens
OUTLINE This is a randomized placebo-controlled double-blind multicenter pilot study Participants are stratified according to prior hormone replacement therapy HRT use discontinued HRT 5 years ago or no prior HRT use vs discontinued HRT 1-5 years ago Patients are randomized to 1 of 3 treatment arms
Arm I Participants receive oral placebo once daily for 12 months and placebo IV over 15 minutes on day 0 and at 6 months
Arm II Participants receive oral letrozole once daily for 12 months and placebo IV over 15 minutes on day 0 and at 6 months
Arm III Participants receive oral letrozole once daily for 12 months and zoledronate IV over 15 minutes on day 0 and at 6 months
In all arms treatment continues in the absence of unacceptable toxicity
After completion of study treatment participants are followed at 3 months
PROJECTED ACCRUAL A total of 120 participants 40 per treatment arm will be accrued for this study
Primary
Compare the percent change in breast density in healthy postmenopausal women with high breast density treated with placebo only vs letrozole and placebo vs letrozole and zoledronate
Compare the percent change in biochemical markers of bone turnover in participants treated with these regimens
Secondary
Compare the bone density in participants treated with these regimens
Compare growth hormone release and insulin-like growth factor levels in participants treated with these regimens
Compare the incidence and severity of adverse events in participants treated with these regimens
OUTLINE This is a randomized placebo-controlled double-blind multicenter pilot study Participants are stratified according to prior hormone replacement therapy HRT use discontinued HRT 5 years ago or no prior HRT use vs discontinued HRT 1-5 years ago Patients are randomized to 1 of 3 treatment arms
Arm I Participants receive oral placebo once daily for 12 months and placebo IV over 15 minutes on day 0 and at 6 months
Arm II Participants receive oral letrozole once daily for 12 months and placebo IV over 15 minutes on day 0 and at 6 months
Arm III Participants receive oral letrozole once daily for 12 months and zoledronate IV over 15 minutes on day 0 and at 6 months
In all arms treatment continues in the absence of unacceptable toxicity
After completion of study treatment participants are followed at 3 months
PROJECTED ACCRUAL A total of 120 participants 40 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 |
|---|---|---|---|
| UVACC-31003 | None | None | None |
| UVACC-HIC-11019 | None | None | None |