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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324713
• Other study ID #: M-2010-1075
• Status: Completed
• Phase: N/A
• First received: September 30, 2010
• Last updated: October 1, 2015
• Start date: July 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
United States	University of Wisconsin Osteoporosis Clinical Center and Research Program	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DXA Bone Mineral Density precision	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.	1 day	No