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T-Score Comparability Between GE Lunar Prodigy and Norland Excel Densitometers (Wildwood)

This study is currently recruiting participants.
Verified by University of Wisconsin, Madison, January 2008

Sponsored by: University of Wisconsin, Madison
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00593437
  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.


Condition
Bone Densitometry

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Retrospective
Official Title:   T-Score Comparability Between GE Lunar Prodigy and Norland Excel Densitometers

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Spine and hip BMD and T-score measurements will be compared between densitometry machines. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   35
Study Start Date:   February 2006
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
diagnosed with normal bone density by Norland Excel
2
diagnosed with osteopenia by Norland Excel densitometer
3
diagnosed with osteoporosis by Norland Excel densitometer

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

ambulatory women age ≥ 40 who have recently had a spine and hip DXA at the Wildwood Clinic on a Norland Excel densitometer


Criteria

Inclusion Criteria:

  • Ambulatory women age 40 years and older
  • Recent spine and hip DXA at Wildwood clinic in Madison, WI
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593437

Contacts
Contact: Diane Krueger, BS     (608) 265-6410     dckruege@wisc.edu    

Locations
United States, Wisconsin
UW Osteoporosis Clinical and Research Program     Recruiting
      Madison, Wisconsin, United States, 53705
      Principal Investigator: Neil Binkley, MD            

Sponsors and Collaborators
University of Wisconsin, Madison

Investigators
Principal Investigator:     Neil Binkley, MD     University of Wisconsin - Institute on Aging    
  More Information

Responsible Party:   University of Wisconsin - Institute on Aging ( Neil Binkley, MD )
Study ID Numbers:   2006-1053
First Received:   January 3, 2008
Last Updated:   January 14, 2008
ClinicalTrials.gov Identifier:   NCT00593437
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
bone density diagnostic equipment discrepancies  

ClinicalTrials.gov processed this record on September 04, 2008




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