Bone Density Clinical Trial
Official title:
Comparison of Xtreme CT and DXA Bone Densitometry
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 |
Verified date | March 2019 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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 |
Status | Clinical Trial | Phase | |
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