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OpenTrials
Completed

NCT Number: NCT01324713

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin Osteoporosis Clinical Center and Research Program

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. DXA Bone Mineral Density precision

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 29, 2011
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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