Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118508
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2005-06-30
Brief Title:
The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal Up to 8 Years Women With Breast Cancer Following Chemotherapy REBBeCA Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal Up to 8 Years Women With Breast Cancer Following Chemotherapy REBBeCA Study
Status:
COMPLETED
Status Verified Date:
2015-08
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:
The purpose of this study is to evaluate the effectiveness of once weekly risedronate in the prevention and treatment of bone loss in premenopausal and newly menopausal women with breast cancer who have received chemotherapy
The hypothesis is that bisphosphonate therapy will prevent bone loss at clinically relevant sites such as the hip and spine The investigators also hypothesize that there will be a correlation between biochemical markers of bone turnover and changes in bone mineral density
The hypothesis is that bisphosphonate therapy will prevent bone loss at clinically relevant sites such as the hip and spine The investigators also hypothesize that there will be a correlation between biochemical markers of bone turnover and changes in bone mineral density
Detailed Description:
Breast cancer is a significant public health problem accounting for approximately 30 of new cancers diagnosed annually Much advancement has been made in the treatment of these cancers which has significantly decreased the mortality rates Treatment including adjuvant chemotherapy and hormonal therapy prolongs disease free survival and overall survival of patients with breast cancer The cytotoxic drugs however can cause premature ovarian failure and subsequent menopause This risk has been reported to range from 53 to 89 Temporary or permanent chemotherapy induced ovarian failure is important because of potential bone loss associated with the estrogen loss Initiating a potent antiresorptive agent risedronate should prevent or improve bone mass in these women
Comparison The investigators will compare bone massmarkers of study subjects receiving risedronate with study subjects receiving placebo All subjects will be provided calcium and vitamin D supplementation as needed
Comparison The investigators will compare bone massmarkers of study subjects receiving risedronate with study subjects receiving placebo All subjects will be provided calcium and vitamin D supplementation as needed
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