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

NCT ID: NCT01544660

Last Updated: 2014-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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

Conditions

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Bone Mineral Density

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Scanning

no treatment

No interventions assigned to this group

scanning

no treatment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Lang

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Department of Radiology, UCSF

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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NIH-Multicenter Interscanner

Identifier Type: -

Identifier Source: org_study_id

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