Evaluation of the XtremeCT Device for the Assessment of Bone (XtremeCT)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Bone Density
• Intervention / Treatment: Procedure: XtremeCT

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.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorks
    • Sheffield, South Yorks, United Kingdom, S5 7AU
      • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Volunteers

Description

Inclusion Criteria:

• Healthy subjects
• Willing to participate
• Aged 16-18, 30-32 or ≥ 70 years

Exclusion Criteria:

• Unable to give informed consent
• Prior fracture of both wrists or both tibiae
• Confirmed fracture of three or more vertebrae between the levels of L1 and L4, or degenerative bone disease preventing three or more vertebrae from being evaluated
• Diagnosis of any disease or condition known to affect bone metabolism
• Use of any medication known to affect bone metabolism

• Pregnancy

  • 16-18 and 30-32 year old women will undergo a urine-based pregnancy test at the study site prior to undergoing any study procedures to avoid unnecessary exposure of a foetus to ionizing radiation.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Men 16 - 18yrs	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; Other Names: Device: XTremeCT; Device: pQCT
Men 30 - 32 yrs	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; Other Names: Device: XTremeCT; Device: pQCT
Men 70 yrs +	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; Other Names: Device: XTremeCT; Device: pQCT
Women 16 - 18 yrs	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; Other Names: Device: XTremeCT; Device: pQCT
Women 30 - 32 yrs	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; Other Names: Device: XTremeCT; Device: pQCT
Women 70 yrs +	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; Other Names: Device: XTremeCT; Device: pQCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To calculate the short-term reproducibility of the XtremeCT device for measurements of bone density and bone structure at the distal radius and tibia in a) teenagers, b) young adults and c) older adults	Data will be analysed following completion of scans. Participants are only involved for 1 day.

Secondary Outcome Measures

Outcome Measure	Time Frame
A secondary endpoint will be agreement between HR-pQCT and pQCT measurements made in the same individuals and at the same measurement sites using the XtremeCT and XCT-2000 respectively	Data will be analysed following completion of scans. Participants are only involved for 1 day.
A secondary endpoint will be correlation of bone turnover markers with XtremeCT measurements	Data will be analysed following completion of scans. Participants are only involved for 1 day.
A secondary endpoint will be correlation of hormones with XtremeCT measurements	Data will be analysed following completion of scans. Participants are only involved for 1 day.

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Jennifer Walsh, Dr, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: February 7, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): June 15, 2012
• Last Update Submitted That Met QC Criteria: June 14, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Bone; Density; pQCT; XtremeCT; Turnover; short-term reproducibility
• Other Study ID Numbers: STH15265