Evaluation of the XtremeCT Device for the Assessment of Bone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01528423
First received: January 25, 2012
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Peripheral Bone Density
Procedure: XtremeCT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the XtremeCT Device for the Assessment of Bone

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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 [ Time Frame: Data will be analysed following completion of scans. Participants are only involved for 1 day. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Data will be analysed following completion of scans. Participants are only involved for 1 day. ] [ Designated as safety issue: No ]
  • A secondary endpoint will be correlation of bone turnover markers with XtremeCT measurements [ Time Frame: Data will be analysed following completion of scans. Participants are only involved for 1 day. ] [ Designated as safety issue: No ]
  • A secondary endpoint will be correlation of hormones with XtremeCT measurements [ Time Frame: Data will be analysed following completion of scans. Participants are only involved for 1 day. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum samples taken for measurement of PINP, CTX, PTH, calcium, creatinine, albumin, testosterone, IGF-1, IGFBP-3 and SHBG


Enrollment: 180
Study Start Date: May 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Volunteers

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528423

Locations
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorks, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Jennifer Walsh, Dr Sheffield Teaching Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01528423     History of Changes
Other Study ID Numbers: STH15265
Study First Received: January 25, 2012
Last Updated: June 14, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
XtremeCT
Density
pQCT
Turnover
Bone
short-term reproducibility

ClinicalTrials.gov processed this record on April 16, 2014