Comparison of Xtreme CT and DXA Bone Densitometry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
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

September 7, 2010
June 4, 2012
August 2010
August 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01199991 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Xtreme CT and DXA Bone Densitometry
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Healthy adult volunteers

Bone Density
Not Provided
Normative database
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
Not Provided
August 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01199991
2010P000462
Not Provided
Joel S. Finkelstein, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Joel S Finkelstein, MD Massachusetts General Hospital
Massachusetts General Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP