Peripheral Bone DensityXtremeCTNCT01528423
Evaluation of the XtremeCT Device for the Assessment of Bone
An observational study of Peripheral Bone Density, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Bone Density
- What is being tested?
- XtremeCT
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Volunteers
Who may be able to join
- Healthy subjects
- Willing to participate
- Aged 16-18, 30-32 or ≥ 70 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorks, S5 7AU
About this study
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.
Read the 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
- Being tested
- XtremeCT
- Keywords
- XtremeCT, Density, pQCT, Turnover, Bone, short-term reproducibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XtremeCTProcedure or surgery
Also called Device: XTremeCT, Device: pQCT
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
| Study group | Role | What they receive |
|---|---|---|
| Men 16 - 18yrs | Not described Receives: Procedure: XtremeCT | |
| Men 30 - 32 yrs | Not described Receives: Procedure: XtremeCT | |
| Men 70 yrs + | Not described Receives: Procedure: XtremeCT | |
| Women 16 - 18 yrs | Not described Receives: Procedure: XtremeCT | |
| Women 30 - 32 yrs | Not described Receives: Procedure: XtremeCT | |
| Women 70 yrs + | Not described Receives: Procedure: XtremeCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Data will be analysed following completion of scans. Participants are only involved for 1 day.
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Data will be analysed following completion of scans. Participants are only involved for 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Bone DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Walsh, Dr, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528423
- Sponsor's protocol ID
- STH15265
- Acronym
- XtremeCT
- Status last verified
- Jun 2012
- First submitted
- 25 Jan 2012
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the XtremeCT Device for the Assessment of Bone
- ClinicalTrials.gov ID
- NCT01528423
- Acronym / sponsor ID
- XtremeCT / STH15265
- Conditions
- Peripheral Bone Density
- Keywords
- XtremeCT, Density, pQCT, Turnover, Bone, short-term reproducibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Men 16 - 18yrs | – | Procedure: XtremeCT |
| Men 30 - 32 yrs | – | Procedure: XtremeCT |
| Men 70 yrs + | – | Procedure: XtremeCT |
| Women 16 - 18 yrs | – | Procedure: XtremeCT |
| Women 30 - 32 yrs | – | Procedure: XtremeCT |
| Women 70 yrs + | – | Procedure: XtremeCT |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Volunteers
Key inclusion criteria (3 listed)
- Healthy subjects
- Willing to participate
- Aged 16-18, 30-32 or ≥ 70 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XtremeCTAlso: Device: XTremeCT, Device: pQCTThe 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 | Procedure or surgery | Men 16 - 18yrs, Men 30 - 32 yrs, Men 70 yrs +, Women 16 - 18 yrs, Women 30 - 32 yrs, Women 70 yrs + |
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Walsh, Dr principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Bone Density, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2012.