Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research

University of California, San Francisco60 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bone Mineral Density

Eligibility

Sex: ALLMin age: 65 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men and women * must be able to lie down on bed Exclusion Criteria: * on wheel chair * age above 80 years 0r less than 65 years

Locations (1)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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