Osteoporosis3DScansNCT00666640
3D Imaging of the Hip Using DXA
An observational study of Osteoporosis and Low-energy Trauma Fracture, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study aims to determine the efficacy and best methods for predicting hip fractures and diagnosing post-menopausal osteoporosis using three dimensional structural engineering models (SEMs) of proximal femoral bone produced using a Hologic Discovery duel-energy x-ray absorptiometry scanner and Hologic's new 3D… Read more about this study
- Who is it for?
- Ages 50 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Low-energy Trauma Fracture
- What is being tested?
- DXA scan of hip and CT scan of hip
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to Jan 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 50 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community Sample Subjects recruited from A+E attendances/fracture clinics at Sheffield hospitals
Who may be able to join
- be female
- at least 5 years post menopausal but <85 years
- be sufficiently mobile to undergo DXA and QCT scanning
- be able and willing to participate in the study and provide written informed consent
Who cannot join
- bi-lateral hip replacement
- have hip replacement on the non-fractured side
- have any history of cancer within the past 5 years excluding skin cancer non melanomas
- have a history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health (secondary osteoporosis)
- have a history of chronic renal disease (as defined by a creatinine clearance of ≤ 30ml/min)
- Acute or chronic hepatic disease
Show all 17Show fewer
- Malabsorption syndromes
- Hyperthyroidism as manifested by TSH outside the lower limit of the normal range
- Hyperparathyroidism
- Hypocalcemia or hypercalcemia
- Osteomalacia
- Cushing's syndrome
- patients who are currently on glucocorticoid therapy
- have a history of any known condition that would interfere with the assessment of DXA or CT of hip
- have markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the investigator
- have participated in another clinical trial involving active therapy 3 months prior to randomisation
- have a known confusional state or dementia as documented in hospital notes, or be unsuitable for approach in the opinion of the physician with duty of care
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bone Biomedical Research Unit, Northern General Hospital
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: Parameters Derived From DXA-based Structural Engineering Models of the Proximal Femur as a Biomarker for Hip Fracture Prediction.
The study aims to determine the efficacy and best methods for predicting hip fractures and diagnosing post-menopausal osteoporosis using three dimensional structural engineering models (SEMs) of proximal femoral bone produced using a Hologic Discovery duel-energy x-ray absorptiometry scanner and Hologic's new 3D Hip(TM) software in comparison to three dimensional SEMs produced using quantitative computed tomography - the current gold standard.
Read the detailed description
Bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry (DXA) have been available to the clinician for the past 20 years and their use forms the basis of current clinical practice guidelines. The measurements are very useful, but they could be improved upon by taking into account the third dimension of bone (depth) and the distribution of mineral within bone. The value of a diagnostic test depends greatly on the strength of association of the measurement with the outcome. If we find that our new approach strengthens the ability of hip DXA measurements to predict fracture then we will have a greatly improved diagnostic test and so can better identify those patients we should treat. Further, such a test would allow better evaluation of new therapies for osteoporosis, particularly those that may alter bone geometry, including anabolic agents such as teriparatide.
Patients attending for study visits will complete a basic questionnaire to collect information on their bone health and lifestyle (the current Metabolic Bone Centre standard questionnaire). Patients will also undergo DXA scans of their hips on a Hologic Discovery DXA machine using a new 3D imaging technique called '3D HipTM'. Hologic will process 3D HipTM scans and provide us with volumetric dataset of the scans before they provide us with a high performance PC and software for us to do the process on-site. They have already installed the software upgrade and necessary hardware to our Discovery densitometry system to enhance the 3D HipTM capability. Patients will attend for a CT scan of their hip at the medical imaging department of the Northern General Hosptial as per standard practice.
50 postmenopausal women who have recently suffered a hip fracture will be recruited to the study. 50 postmenopausal age matched controls will also be recruited. Subjects will give informed consent and a study visit will be arranged for them to attend for a DXA scan and a CT scan. At the study visit basic demographic data and a brief medical history will be collected on study specific Case Report Forms (CRF).
The intended outcomes of the study are 1) To establish the diagnostic accuracy for hip fracture of the 3D HipTM and SEMs derived from the 3D HipTM, and to determine how much better the 3D HipTM is over the traditional 2D DXA in a case controlled study. 2) To compare three dimensional SEMs of the proximal femur derived from 3D Hip(TM) against simulated SEMs derived using quantitative computed tomography.
- Conditions
- Osteoporosis, Low-energy Trauma Fracture
- Being tested
- DXA scan of hip, CT scan of hip
- Keywords
- Osteoporosis, Fracture, DXA, Dual energy x-ray absorptiometry, Computed tomography, 3D DXA
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA scan of hipDevice
Dual-energy X-ray Absorptiometry scan
CT scan of hipDevice
Computed Tomography scan
| Study group | Role | What they receive |
|---|---|---|
| 1 | 50 subjects who have suffered a hip fracture Receives: Device: DXA scan of hip; Device: CT scan of hip | |
| 2 | 50 age matched controls Receives: Device: DXA scan of hip; Device: CT scan of hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the diagnostic accuracy for hip fracture of the 3D HipTM and SEMs derived from the 3D HipTM, and to determine how much better the 3D HipTM is over the traditional 2D DXA in a case controlled study.
Measured: 2 years
Secondary outcomes (1)
The secondary outcome measures are parameters related to the hip structure, such as volumetric bone mineral density, cross sectional area, moment of inertia, section modulus, cortical thickness and buckling ratio.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Hologic, Inc.
- Responsible party
- Sponsor
- Investigators
- Lang Yang, Dr, Study director, Sheffield UniversityEugene McCloskey, Dr, Study director, Sheffield University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666640
- Sponsor's protocol ID
- STH14748
- Acronym
- 3DScans
- Status last verified
- Sep 2014
- First submitted
- 23 Apr 2008
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameters Derived From DXA-based Structural Engineering Models of the Proximal Femur as a Biomarker for Hip Fracture Prediction.
- ClinicalTrials.gov ID
- NCT00666640
- Acronym / sponsor ID
- 3DScans / STH14748
- Conditions
- Osteoporosis, Low-energy Trauma Fracture
- Keywords
- Osteoporosis, Fracture, DXA, Dual energy x-ray absorptiometry, Computed tomography, 3D DXA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medical Research Council, Hologic, Inc.
- Study start
- May 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Apr 2008 (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 study aims to determine the efficacy and best methods for predicting hip fractures and diagnosing post-menopausal osteoporosis using three dimensional structural engineering models (SEMs) of proximal femoral bone produced using a Hologic Discovery duel-energy x-ray absorptiometry scanner and Hologic's new 3D Hip(TM) software in comparison to three dimensional SEMs produced using quantitative computed tomography - the current gold standard.
Detailed description
Bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry (DXA) have been available to the clinician for the past 20 years and their use forms the basis of current clinical practice guidelines. The measurements are very useful, but they could be improved upon by taking into account the third dimension of bone (depth) and the distribution of mineral within bone. The value of a diagnostic test depends greatly on the strength of association of the measurement with the outcome. If we find that our new approach strengthens the ability of hip DXA measurements to predict fracture then we will have a greatly improved diagnostic test and so can better identify those patients we should treat. Further, such a test would allow better evaluation of new therapies for osteoporosis, particularly those that may alter bone geometry, including anabolic agents such as teriparatide.
Patients attending for study visits will complete a basic questionnaire to collect information on their bone health and lifestyle (the current Metabolic Bone Centre standard questionnaire). Patients will also undergo DXA scans of their hips on a Hologic Discovery DXA machine using a new 3D imaging technique called '3D HipTM'. Hologic will process 3D HipTM scans and provide us with volumetric dataset of the scans before they provide us with a high performance PC and software for us to do the process on-site. They have already installed the software upgrade and necessary hardware to our Discovery densitometry system to enhance the 3D HipTM capability. Patients will attend for a CT scan of their hip at the medical imaging department of the Northern General Hosptial as per standard practice.
50 postmenopausal women who have recently suffered a hip fracture will be recruited to the study. 50 postmenopausal age matched controls will also be recruited. Subjects will give informed consent and a study visit will be arranged for them to attend for a DXA scan and a CT scan. At the study visit basic demographic data and a brief medical history will be collected on study specific Case Report Forms (CRF).
The intended outcomes of the study are 1) To establish the diagnostic accuracy for hip fracture of the 3D HipTM and SEMs derived from the 3D HipTM, and to determine how much better the 3D HipTM is over the traditional 2D DXA in a case controlled study. 2) To compare three dimensional SEMs of the proximal femur derived from 3D Hip(TM) against simulated SEMs derived using quantitative computed tomography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: DXA scan of hip, Device: CT scan of hip50 subjects who have suffered a hip fracture |
| 2 | – | Device: DXA scan of hip, Device: CT scan of hip50 age matched controls |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample Subjects recruited from A+E attendances/fracture clinics at Sheffield hospitals
Key inclusion criteria (4 listed)
- be female
- at least 5 years post menopausal but <85 years
- be sufficiently mobile to undergo DXA and QCT scanning
- be able and willing to participate in the study and provide written informed consent
Key exclusion criteria (17 listed)
- bi-lateral hip replacement
- have hip replacement on the non-fractured side
- have any history of cancer within the past 5 years excluding skin cancer non melanomas
- have a history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health (secondary osteoporosis)
- have a history of chronic renal disease (as defined by a creatinine clearance of ≤ 30ml/min)
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 |
|---|---|---|
| DXA scan of hipDual-energy X-ray Absorptiometry scan | Device | 1, 2 |
| CT scan of hipComputed Tomography scan | Device | 1, 2 |
Primary outcome
To establish the diagnostic accuracy for hip fracture of the 3D HipTM and SEMs derived from the 3D HipTM, and to determine how much better the 3D HipTM is over the traditional 2D DXA in a case controlled study.
Time frame: 2 years
1 secondary outcome
The secondary outcome measures are parameters related to the hip structure, such as volumetric bone mineral density, cross sectional area, moment of inertia, section modulus, cortical thickness and buckling ratio.
Time frame: 2 years
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 19 Sep 2014.
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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.
Lang Yang, Dr study director
Sheffield University
Eugene McCloskey, Dr study director
Sheffield University
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 Osteoporosis and Low-energy Trauma Fracture, 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 4 inclusion and 17 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 19 Sep 2014. 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 establish the diagnostic accuracy for hip fracture of the 3D HipTM and SEMs derived from the 3D HipTM, and to determine how much better the 3D HipTM is over the traditional 2D DXA in a case controlled study. (time frame: 2 years). 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 19 Sep 2014.