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

NCT01544660 | Completed

• 1 other identifier: NIH-Multicenter Interscanner
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Mineral Density

Keywords

spine and hip scan; BMD

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Development of open-source image analysis metric for vQCT

  Time frame will be 3 hours for a visit

Study Arms (2)

Scanning

no treatment

scanning

no treatment

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy men and women aged 65-80

You may qualify if:

• Healthy men and women
• must be able to lie down on bed

You may not qualify if:

• on wheel chair
• age above 80 years 0r less than 65 years

Sponsors & Collaborators

• University of California, San Francisco: lead
• Mayo Clinic: collaborator

Study Sites (1)

Department of Radiology, UCSF

San Francisco, California, 94107, United States

Location

Study Officials

• Thomas Lang

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: March 6, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

US (1)