Evaluation of Bone Length Measurement

Osteoporosis Clinical Trial

Official title:

Evaluation of Bone Length Measurement Using Lunar iDXA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165527
• Other study ID #: HUM29462
• Status: Completed
• Phase: N/A
• First received: June 11, 2014
• Last updated: June 13, 2014
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer software program can make accurate measurements of the length of leg bones compared to conventional x-rays.

Description:

The investigators would like to see how well the calculation of bone length using Lunar iDxa compares to conventional x-ray since the Lunar iXDA exposed patients to less radiation than conventional x-rays.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 yrs. of age or older

• Have recent x-rays of lower extremity

• Are at least 3 feet 7 inches tall and not taller than 6 feet 7 inches.

Exclusion Criteria:

• Are unwilling to read and sign the consent

• Are pregnant or if subject has not had a negative pregnancy test just prior to the iXDA scan

• Have severe deformities of your legs or back

• Unable to lay on the scanning table for the scan

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Calcification
• Calcinosis
• Osteoporosis

Intervention

Procedure:
• Lunar iXDA scan
Subject will receive a total body scan taken by the Lunar iXDA. This scan will take approximately 8 minutes to complete. Following the scan, the computer of the Lunar iXDA will calculate the bone length.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg (Femur and Tibia) bone length measurement in centimeters using iDXA	Lunar iXDA computer will calculate the bone length following a total body scan taken by the Lunar iDXA and compare results from conventional x-ray to determine accuracy.	scan time is 8 minutes	No