Expired Study
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Madison, Wisconsin 53705


Purpose:

Differences in determining bone density scores have been found when comparing different bone density machines. Reducing differences between machines will improve diagnostic agreement for patients measured at different clinics. This study will test if this difference exists between the Norland Excel, such as the one at Wildwood Clinic, and the GE Healthcare Lunar Prodigy at the UW Osteoporosis Clinical Research Center.


Criteria:

Inclusion Criteria: - Ambulatory women age 40 years and older - Recent spine and hip DXA at Wildwood clinic in Madison, WI


Study is Available At:


Original ID:

2006-1053


NCT ID:

NCT00593437


Secondary ID:


Study Acronym:

Wildwood


Brief Title:

T-score Comparability Between GE Lunar Prodigy and Norland Excel Densitometers


Official Title:

T-score Comparability Between GE Lunar Prodigy and Norland Excel Densitometers


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Wisconsin, Madison


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Retrospective


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

35


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Neil Binkley, MD
Principal Investigator
University of Wisconsin - Institute on Aging

Study Dates

Start Date:February 2006
Completion Date:December 2006
Completion Type:Actual
Primary Completion Date:December 2006
Primary Completion Type:Actual
Verification Date:April 2010
Last Changed Date:October 1, 2015
First Received Date:January 3, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Spine and hip BMD and T-score measurements will be compared between densitometry machines.
Time Frame:2 weeks
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:3
Description:diagnosed with osteoporosis by Norland Excel densitometer
Study Arm Type:Other
Arm Name:2
Description:diagnosed with osteopenia by Norland Excel densitometer
Study Arm Type:Other
Arm Name:1
Description:diagnosed with normal bone density by Norland Excel

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison

Samples and Retentions

Study Population: ambulatory women age ≥ 40 who have recently had a spine and hip DXA at the Wildwood Clinic on a Norland Excel densitometer
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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