Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354302
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2006-07-19
Brief Title:
Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-01
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 Learning about the effect of exemestane and anastrozole on bone mineral density in postmenopausal women with primary breast cancer may help plan treatment decrease the risk of broken bones and help patients live more comfortably
PURPOSE This phase III trial is studying bone mineral density in postmenopausal women with primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27
PURPOSE This phase III trial is studying bone mineral density in postmenopausal women with primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27
Detailed Description:
OBJECTIVES
Determine whether there is a clinically relevant difference in bone mineral density BMD at 2 years in postmenopausal women with primary breast cancer with or without osteopenia or osteoporosis treated with exemestane vs anastrozole on protocol CAN-NCIC-MA27
OUTLINE This is a multicenter companion study Patients are stratified according to baseline bone mineral density BMD measurement T-score -20 standard deviation SD no osteopenia or osteoporosis vs T-score -20 SD
NOTE The lowest of the two T-scores L1-L4 or total hip
Blood samples for the identification of bone biomarkers formation marker serum amino-terminal procollagen 1 extension peptide P1NP and resorption marker serum N-telopeptide are obtained at baseline and at 6 and 12 months BMD is determined by dual-energy x-ray absorptiometry DEXA at baseline and then annually for 5 years or for as long as patient is receiving treatment on protocol CAN-NCIC-MA27
Patients receive oral calcium and oral cholecalciferol vitamin D daily Patients with osteopenia or osteoporosis stratum II also receive oral bisphosphonate therapy
PROJECTED ACCRUAL A total of 408 patients will be accrued for this study
Determine whether there is a clinically relevant difference in bone mineral density BMD at 2 years in postmenopausal women with primary breast cancer with or without osteopenia or osteoporosis treated with exemestane vs anastrozole on protocol CAN-NCIC-MA27
OUTLINE This is a multicenter companion study Patients are stratified according to baseline bone mineral density BMD measurement T-score -20 standard deviation SD no osteopenia or osteoporosis vs T-score -20 SD
NOTE The lowest of the two T-scores L1-L4 or total hip
Blood samples for the identification of bone biomarkers formation marker serum amino-terminal procollagen 1 extension peptide P1NP and resorption marker serum N-telopeptide are obtained at baseline and at 6 and 12 months BMD is determined by dual-energy x-ray absorptiometry DEXA at baseline and then annually for 5 years or for as long as patient is receiving treatment on protocol CAN-NCIC-MA27
Patients receive oral calcium and oral cholecalciferol vitamin D daily Patients with osteopenia or osteoporosis stratum II also receive oral bisphosphonate therapy
PROJECTED ACCRUAL A total of 408 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 |
|---|---|---|---|
| CDR0000483099 | OTHER | PDQ | None |
| CAN-NCIC-MA27B | REGISTRY | None | None |
| SWOG-NCIC-MA27B | OTHER | None | None |
| NCCTG-NCIC-MA27B | OTHER | None | None |
| CAN-NCIC-BONE | None | None | None |