Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436917
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2007-02-15
Brief Title:
Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I Stage II or Stage IIIA Primary Breast Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Zoledronic Acid for Treatment of Osteopenia and Osteoporosis in Women With Primary Breast Cancer Undergoing Adjuvant Aromatase Inhibitor Letrozole Therapy
Status:
COMPLETED
Status Verified Date:
2016-04
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 Zoledronate may reduce bone loss in patients receiving letrozole for breast cancer
PURPOSE This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporosis in postmenopausal women receiving letrozole for stage I stage II or stage IIIA primary breast cancer
PURPOSE This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporosis in postmenopausal women receiving letrozole for stage I stage II or stage IIIA primary breast cancer
Detailed Description:
OBJECTIVES
Primary
Assess changes in total lumbar spine bone mineral density BMD from baseline to 12 months in postmenopausal women treated with zoledronate for osteopenia or osteoporosis and letrozole for hormone receptor-positive stage I-IIIA primary breast cancer
Secondary
Determine changes in total lumbar spine BMD from baseline to 2 3 4 and 5 years in these patients
Determine changes in femoral neck BMD from baseline to 1 2 3 4 and 5 years in these patients
Determine time to disease progression in these patients
OUTLINE This is an open-label multicenter study
Adjuvant aromatase inhibitor therapy Patients receive oral letrozole daily for up to 5 years in the absence of disease progression or unacceptable toxicity
Osteoporosis management Patients receive zoledronate IV over 15 minutes on day 1 Patients also receive oral elemental calcium twice daily and oral vitamin D daily for 6 months Treatment repeats every 6 months for up to 5 years in the absence of disease progression or unacceptable toxicity
Patients undergo total lumbar spine and hip femoral neck bone density testing by dual energy x-ray absorptiometry DXA at baseline and annually for 5 years
After completion of study therapy patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Primary
Assess changes in total lumbar spine bone mineral density BMD from baseline to 12 months in postmenopausal women treated with zoledronate for osteopenia or osteoporosis and letrozole for hormone receptor-positive stage I-IIIA primary breast cancer
Secondary
Determine changes in total lumbar spine BMD from baseline to 2 3 4 and 5 years in these patients
Determine changes in femoral neck BMD from baseline to 1 2 3 4 and 5 years in these patients
Determine time to disease progression in these patients
OUTLINE This is an open-label multicenter study
Adjuvant aromatase inhibitor therapy Patients receive oral letrozole daily for up to 5 years in the absence of disease progression or unacceptable toxicity
Osteoporosis management Patients receive zoledronate IV over 15 minutes on day 1 Patients also receive oral elemental calcium twice daily and oral vitamin D daily for 6 months Treatment repeats every 6 months for up to 5 years in the absence of disease progression or unacceptable toxicity
Patients undergo total lumbar spine and hip femoral neck bone density testing by dual energy x-ray absorptiometry DXA at baseline and annually for 5 years
After completion of study therapy patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2330-05 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| MC05C8 | OTHER | None | None |