T-score Comparability Between GE Lunar Prodigy and Norlan... | NCT00593437

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

NCT00593437

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Oct 5, 2015Estimated

Enrollment

35Estimated

Phase

Not provided

Conditions

Bone Densitometry

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Jan 3, 2008

First Submission Date that Met QC Criteria

Jan 14, 2008

First Posted Date

Jan 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2015

Last Update Posted Date

Oct 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spine and hip BMD and T-score measurements will be compared between densitometry machines.		2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil Binkley, MD	University of Wisconsin - Institute on Aging	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin Osteoporosis Clinical and Research Program		Madison	Wisconsin	53705	United States