Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT01544660
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2012-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research
Status:
COMPLETED
Status Verified Date:
2014-04
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:
Interscanner
Brief Summary:
Our overarching aim is to set up a procedural, analytic and developmental framework to establish CT of the central and peripheral skeleton as a clinically useful biomarker for skeletal strength in the clinical research and ultimately in the clinical setting. To accomplish this, the investigators will develop and validate phantoms and scanning procedures to standardize strength and structure measurements between different vQCT scanners and develop standardized acquisition, analytical, and quality control techniques for HR-pQCT with an emphasis on optimization for multi-center studies.
Detailed Description:
The investigators will develop new calibration phantoms to address inter and intra scanner variability in vQCT and HRpQCT. Phantom sets to evaluate inter-scanner disparity and determine corrections to apply to in vivo scan data in the multi-center settings. These methods will be validated in a multi-center phantom study and in a 120 patients
Study Oversight
Has Oversight DMC:
False
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?: