Overview

This trial is active, not recruiting.

Condition bone density
Sponsor Massachusetts General Hospital
Start date August 2010
End date August 2026
Trial size 400 participants
Trial identifier NCT01199991, 2010P000462

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm

Primary Outcomes

Measure
Xtreme CT
time frame: single measurement at baseline
DXA
time frame: single measurement at baseline

Eligibility Criteria

Male or female participants from 20 years up to 40 years old.

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

Additional Information

Official title Comparison of Xtreme CT and DXA Bone Densitometry
Principal investigator Joel S Finkelstein, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.