Comparison of Xtreme CT and DXA Bone Densitometry

Bone Density Clinical Trial

Official title:

Comparison of Xtreme CT and DXA Bone Densitometry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01199991
• Other study ID #: 2010P000462
• Status: Terminated
• Start date: August 2010
• Est. completion date: June 29, 2018

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: June 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Density

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Xtreme CT	Bone imaging of forearm and lower leg	single measurement at baseline
Primary	DXA	Bone imaging of spine, hip, total body, and forearm	single measurement at baseline