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Comparison of Xtreme CT and DXA Bone Densitometry

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ClinicalTrials.gov Identifier: NCT01199991
Recruitment Status : Active, not recruiting
First Posted : September 13, 2010
Last Update Posted : April 1, 2016
Information provided by (Responsible Party):
Joel S. Finkelstein, MD, Massachusetts General Hospital

Brief Summary:

Dual-energy x-ray absorptiometry (DXA) is currently the most widely used tool for determining bone density. However, most experts consider DXA an imperfect and intermediate technology. DXA is subject to artifact from arthritis and body composition, and also cannot account for geometric or material properties of bone which are also important components of bone strength.

Xtreme CT (high-resolution peripheral quantitative computed tomography, HR-pQCT) is a new technology with dramatically improved spatial resolution. It is able to define bones' cortical and trabecular surfaces in a three-dimensional manner, and therefore provides information on bone microarchitecture as well as bone density. As such, it may provide new information about characteristics of bone strength.

The purpose of this study is to compare Xtreme CT to DXA measurements of bone density, and also to generate a normative database of healthy young adults. This cross-sectional study involves a single visit where both Xtreme CT and DXA measurements will be obtained for a single time-point. This normative database will allow us to generate clinically relevant comparisons between the two imaging technologies.

Condition or disease
Bone Density

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comparison of Xtreme CT and DXA Bone Densitometry
Study Start Date : August 2010
Estimated Primary Completion Date : August 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density
U.S. FDA Resources

Normative database

Primary Outcome Measures :
  1. Xtreme CT [ Time Frame: single measurement at baseline ]
    Bone imaging of forearm and lower leg

  2. DXA [ Time Frame: single measurement at baseline ]
    Bone imaging of spine, hip, total body, and forearm

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult volunteers

Inclusion Criteria:

  • Adults age 20-40 years

Exclusion Criteria:

  • Pregnancy
  • History of bone modifying diseases (hyperparathyroidism, Paget's, hyperthyroidism, renal failure, nephrolithiasis, liver disease, eating disorder)
  • History of amenorrhea
  • Use of chronic steroids for >3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199991

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Joel S Finkelstein, MD Massachusetts General Hospital

Responsible Party: Joel S. Finkelstein, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01199991     History of Changes
Other Study ID Numbers: 2010P000462
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016