NCT01528423

Evaluation of the XtremeCT Device for the Assessment of Bone

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

The research is intended to evaluate the short-term reproducibility of the XtremeCT device for measurements of peripheral bone density and bone structure in population-based volunteers from different age groups and to compare the XtremeCT with current peripheral quantitative computed tomography (pQCT) technology. The investigators will also assess the correlation between XtremeCT measurements of bone structure with hormones and biochemical markers of bone turnover.

Detailed description

The investigators plan to perform high resolution-peripheral quantitative computer tomography (HR-pQCT) using the XtremeCT device in future research studies to investigate the structural changes that occur during adolescence and young adulthood to attain peak bone mass (peak bone strength) and to evaluate the structural effects of anabolic treatments for osteoporosis. This preliminary study will establish the short term precision of the device in the populations that the investigators are likely to study and whether the new device is superior to their current pQCT device. It will also provide information on how measurements from the new device relate to bone turnover markers, which are one of their standard assessments of bone metabolism. They will also determine whether hormones that influence bone metabolism have specific effect on different components of bone structure. By providing data on the size and variability of differences in bone structure by gender and at important stages of skeletal development (end of longitudinal growth, peak bone mass and aging) this study will also form the basis of power calculations for future longitudinal studies.

Conditions

• Peripheral Bone Density

Interventions

Type	Name	Description
PROCEDURE	XtremeCT	The scanning protocol for each subject will be as follows: Non-dominant, non-fractured distal radius x 2 with repositioning between scans Non-dominant, non-fractured distal tibia x 2 with repositioning between scans using XtremeCT device and Non-dominant forearm x 2 with repositioning between scans Non-dominant lower leg x 2 with repositioning between scans using standard pQCT device

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-02-08
• Last updated: 2012-06-15

Locations

1 site across 1 country: United Kingdom