An observational study in Bone Mineral Density, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-16.
Sponsored by University of California, San Francisco · Observational
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.
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
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy men and women aged 65-80
Exclusion Criteria:
no treatment
no treatment
Develop and Validate phantoms and scanning procedures to standardize strength and structure measurements between different scanners.
Correction of the in vivo images using the proposed inter-scanner calibration approaches will improve the quality of multi-site data by reducing the variability in CT structure and strength measures. To study the Multi-center standardization of vQCT and HR-pQCT imaging we will develop new calibration phantoms to address inter and intra-scanner variability in vQCT and HRpQCT bone strength and structure estimates.
Time frame: one visit lasting 3 hours for each subject.
Development of open-source image analysis metric for vQCT
To provide standardized analysis of future clinical studies and retrospective analysis of past trials, we will develop a set of image analysis metrics for vQCT (trabecular, cortical and integral BMD, cortical thickness, cross-sectional areas, axial and bending strength estimates). These metrics will be made available to the community in an open source format, allowing them to be incorporated into commercial software platforms at the discretion of the manufacturer, incorporation as a plug-in for NIH supported programs such as MIPAV.
Time frame: Time frame will be 3 hours for a visit
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco