Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504166
Status:
COMPLETED
Last Update Posted:
2013-08-14
First Post:
2007-07-17
Brief Title:
Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal
Status:
COMPLETED
Status Verified Date:
2013-07
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 changes in bone structure as determined by magnetic resonance imaging measurements among early postmenopausal women after 24 months of treatment with alendronate 70 mg once a week as compared to placebo
Detailed Description:
This is a randomized double-blind 24-month study Fifty-five postmenopausal women age range of 45-65 years with low bone density will be recruited with half of the subjects receiving alendronate 2800 IU of vitamin D once weekly the other half receiving placebo 2800 IU of vitamin D once weekly All study subjects will receive supplemental calcium 1000 mgday Vitamin D 400 IUday Measurements of microarchitecture will be made in the wrist ankle and hip and the changes in trabecular bone will be assessed at 0 12 and 24 months Markers of bone turnover and bone mineral density BMD will be used to characterize the cohort and postmenopausal changes in bone turnover and density
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