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

Bone Mineral Density Clinical Trial

— Interscanner  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544660
• Other study ID #: NIH-Multicenter Interscanner
• Status: Completed
• Phase: N/A
• First received: February 14, 2012
• Last updated: April 15, 2014
• Start date: April 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Mineral Density

Locations

Country	Name	City	State
United States	Department of Radiology, UCSF	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one visit lasting 3 hours for each subject.	No
Secondary	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 will be 3 hours for a visit	No