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

NCT01324713 | Completed

• 1 other identifier: M-2010-1075
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Males

Females

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 90 men and 90 women volunteers who are aged 65 years and older, able and willing to provide informed consent.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Osteoporosis Clinical Center and Research Program

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Neil Binkley, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: March 29, 2011
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 5, 2015

Record last verified: 2011-03

Locations

US (1)