Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421447
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2007-01-10
Brief Title:
Bone Geometry and Muscle Density Changes in Postmenopausal Women and Breast Cancer Patients Prescribed Anastrozole
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Bone Geometry and Muscle Density Changes in Postmenopausal Women and Breast Cancer Patients Prescribed Anastrozole
Status:
COMPLETED
Status Verified Date:
2015-09
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 primary objective of this study is to determine if trabecular or cortical volumetric bone mineral density vBMD change over time in postmenopausal breast cancer patients who are prescribed Anastrozole as measured by pQCT at the proximal and distal radius and tibia
Detailed Description:
In bone where estrogen is required to maintain density there is indication of increased turnover in patients prescribed Aromatase Inhibitors However there are no studies to date that prospectively quantify the impact of Aromatase inhibitors on bone quality Furthermore the actual effects and clinical significance of adjuvant chemotherapy and supportive medications on bone quality in women with breast carcinoma is unknown The current study proposes to prospectively assess novel skeletal health outcomes namely trabecular structure connectivity hole size and bone geometry bone area cortical thickness among women with breast cancer being treated with Anastrozole Not only will the current study provide a better understanding of the changes in bone quality and muscle mass after Anastrozole treatment it will provide important information about the development of secondary skeletal complications in this population Therefore the potential to collect data prospectively from a cohort of individuals with breast cancer being treated with Anastrozole represents an important step to advance knowledge in this area Also by examining bone quality and secondary complications in a diverse cohort of patients who vary with respect to radiation therapy chemotherapy and additional medications we can begin to identify patterns of musculoskeletal change and predictors of these changes
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