NCT01199991

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2018

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

7.9 years

First QC Date

September 7, 2010

Last Update Submit

March 13, 2019

Conditions

Bone Density

Outcome Measures

Primary Outcomes (2)

  • Xtreme CT

    Bone imaging of forearm and lower leg

    single measurement at baseline

  • DXA

    Bone imaging of spine, hip, total body, and forearm

    single measurement at baseline

Study Arms (1)

Normative database

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult volunteers

You may qualify if:

  • Adults age 20-40 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Joel S Finkelstein, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 13, 2010

Study Start

August 1, 2010

Primary Completion

June 29, 2018

Study Completion

June 29, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

US(1)