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

Completed

• Conditions: Osteoporosis

• Registration Number: NCT01324713
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-09-30
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-03
• Study First Submitted QC: 2011-03-25
• Study First Posted: 2011-03-29
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DXA Bone Mineral Density precision	1 day	The primary analysis will compare DXA BMD precision (mean square error/variance) in males and females, pooled across technicians, using the two-sample F-test for equality of variances. Separate analyses will also be performed for each technician. In addition, due to the sensitivity of the F-test to the normality assumption, a secondary analysis will perform the same comparisons using Levene's test. A nominal two-sided p-value of 0.05 will be regarded as statistically significant.

Trial Locations

Locations (1)

University of Wisconsin Osteoporosis Clinical Center and Research Program; 🇺🇸 Madison, Wisconsin, United States