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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01199991
Other study ID # 2010P000462
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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