Does Gender Play a Role in Bone-mineral Density Measurement Precision?

NCT ID: NCT01324713

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-01-31

Brief Summary

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Bone mineral density (BMD) measurement using dual-energy x-ray absorptiometry (DXA) is the current gold standard for osteoporosis diagnosis and therapy monitoring. Like all quantitative tests, there is some variability in BMD results obtained when scanning a person more than once. As such, it is current clinical practice, based on the recommendation of the International Society for Clinical Densitometry, that each technologist perform a precision assessment. This approach consists of scanning 30 people twice; the data from which allow determination of what constitutes a real difference in BMD with 95% confidence. A precision assessment typically evaluates a specific clinic's population, using the age range and genders seen at that clinic. However men generally have larger, but often more arthritic, bones than women which may impact the precision results. Therefore, it is possible that gender-specific precision values should be used in clinical practice, however this issue has never been investigated.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Males

No interventions assigned to this group

Females

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 65 years
* Able and willing to sign informed consent

Exclusion Criteria

* Inability to have DXA scans performed due to weight ≥ 450 pounds (exceeds densitometer table limit)
* Metallic hardware in, or overlaying, any of the measured skeletal sites
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Binkley, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Osteoporosis Clinical Center and Research Program

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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M-2010-1075

Identifier Type: -

Identifier Source: org_study_id

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