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Comparison of Xtreme CT and DXA Bone Densitometry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Joel S. Finkelstein, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01199991
First received: September 7, 2010
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Bone Density

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:

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

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Xtreme CT [ Time Frame: single measurement at baseline ] [ Designated as safety issue: No ]
    Bone imaging of forearm and lower leg

  • DXA [ Time Frame: single measurement at baseline ] [ Designated as safety issue: No ]
    Bone imaging of spine, hip, total body, and forearm


Estimated Enrollment: 400
Study Start Date: August 2010
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normative database

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy adult volunteers

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199991

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

No publications provided

Responsible Party: Joel S. Finkelstein, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01199991     History of Changes
Other Study ID Numbers: 2010P000462
Study First Received: September 7, 2010
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013