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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men 16 - 18yrs |
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| Men 30 - 32 yrs |
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| Men 70 yrs + |
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| Women 16 - 18 yrs |
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| Women 30 - 32 yrs |
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| Women 70 yrs + |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XtremeCT | Procedure | 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 |
| Measure | Description | 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
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
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Volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Walsh, Dr | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | South Yorks | S5 7AU | United Kingdom |
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Serum samples taken for measurement of PINP, CTX, PTH, calcium, creatinine, albumin, testosterone, IGF-1, IGFBP-3 and SHBG
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| 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. |