Ignite Creation Date:
2024-05-05 @ 11:34 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01367730
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2011-06-02
Brief Title:
Assessment of Bone Micro-Architecture Using HR-pQCT
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Non-Invasive Assessment of Bone Micro-architecture and Strength Changes in Men With Osteopenia and Osteoporosis
Status:
COMPLETED
Status Verified Date:
2014-12
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:
In the context of male osteoporosis we hypothesize that regional changes in trabecular bone as well as changes in cortical porosity will play a major role and thus also affect bone strength In developing therapeutics the response of individual compartments regional variations post-therapy will have considerable impact on selecting the therapies as well as monitoring response to therapy This study a precursor to other therapeutic trials will lay the ground-work for the future
Detailed Description:
We will recruit 80 subjects who will be stratified into groups based on their T-scores All subjects will be imaged at Baseline and 12 months Measures of bone micro-architecture in the tibia and radius using peripheral computed tomography bone strength measures through finite element analysis will be obtained at all time points DXA measures at the spine femur and forearm will be obtained as reference measures In addition whole body DXA scans will be performed for assessment of body composition
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