Analysis of Bone Micro-Architecture as a Clinical Biomarker for Image-Based Fracture Risk Estimation.
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Osteoporosis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 4/6/2019 |
| Start Date: | June 2016 |
| End Date: | June 2021 |
Multidimensional Analysis of Bone Micro-Architecture as a Clinical Biomarker for Image-Based Quantitative Fracture Risk Estimation.
Osteoporosis is a common disease among elderly people, which leads to an increased bone
fracture risk. Bone fractures can greatly reduce quality of life and increase age-related
problems including reduced life expectancy. In clinical practice, a bone mineral density
(BMD) scan using dual-energy X-ray absorptiometry (DEXA) is used for diagnosing osteoporosis.
However, DEXA does not always accurately predict who will develop fractures and who will not.
This is because bone mineral density alone does not capture all of the factors that
contribute to bone strength. One factor bone mineral density does not measure is trabecular
microarchitecture of bone (structure of bone).
Our goal in this study is to use a specialized CT scan called Dual-Energy CT (DECT) to
capture information about the trabecular (spongy) bone in the vertebra of the lower (lumbar)
spine. Research has shown that this kind of information helps in predicting bone strength in
bone specimens. The investigator will use this information to develop a method to more
accurately predict which patients are likely to experience fractures of the lumbar vertebra.
These are the most common type of fractures associated with osteoporosis.
The participant is being asked to participate in this research study because a physician is
treating the participant for osteoporosis and the participant has met the initial criteria to
participate in the study. Participation in this study involves having a DECT scan, as well as
a DEXA scan if the participant has not had one recently (within two months).
Research studies include only those individuals who choose to take part. Please take time to
make a decision. Please ask the study doctor or the study staff to explain any words or
information that are not understood. The participant may also want to discuss it with family
members, friends or other health care providers.
fracture risk. Bone fractures can greatly reduce quality of life and increase age-related
problems including reduced life expectancy. In clinical practice, a bone mineral density
(BMD) scan using dual-energy X-ray absorptiometry (DEXA) is used for diagnosing osteoporosis.
However, DEXA does not always accurately predict who will develop fractures and who will not.
This is because bone mineral density alone does not capture all of the factors that
contribute to bone strength. One factor bone mineral density does not measure is trabecular
microarchitecture of bone (structure of bone).
Our goal in this study is to use a specialized CT scan called Dual-Energy CT (DECT) to
capture information about the trabecular (spongy) bone in the vertebra of the lower (lumbar)
spine. Research has shown that this kind of information helps in predicting bone strength in
bone specimens. The investigator will use this information to develop a method to more
accurately predict which patients are likely to experience fractures of the lumbar vertebra.
These are the most common type of fractures associated with osteoporosis.
The participant is being asked to participate in this research study because a physician is
treating the participant for osteoporosis and the participant has met the initial criteria to
participate in the study. Participation in this study involves having a DECT scan, as well as
a DEXA scan if the participant has not had one recently (within two months).
Research studies include only those individuals who choose to take part. Please take time to
make a decision. Please ask the study doctor or the study staff to explain any words or
information that are not understood. The participant may also want to discuss it with family
members, friends or other health care providers.
Osteoporosis is a common disease among elderly people, the progression of which leads to an
increased bone fracture risk, which can adversely affect quality of life and increase
age-related morbidity/mortality. The National Osteoporosis Foundation forecast that by 2015,
osteoporosis will be responsible for three million fractures resulting in $25.3 billion in
healthcare costs. This highlights an urgent demand for methods to accurately predict
osteoporotic fracture risk for clinical assessment and management of osteoporosis.
In clinical practice, dual-energy X-ray absorptiometry (DEXA) is the traditional and only
method of diagnosing osteoporosis based on BMD measurements. However, DEXA has certain
limitations, and a considerable overlap exists in BMD values between individuals who develop
fractures and those who do not. This reflects that BMD does not capture all of the factors
that contribute to bone strength. One such factor is trabecular microarchitecture of bone,
well recognized in the definition of osteoporosis.
Ex vivo studies have demonstrated that trabecular bone microarchitecture constitutes an
important component of bone strength, independent of BMD. However, trabecular
microarchitecture is not considered in the evaluation of fracture risk in clinical practice.
Several imaging techniques have been reviewed as potential candidates for clinical evaluation
of trabecular bone microarchitecture. Technological improvements in high resolution X-ray
imaging and MRI are providing increasingly accurate data on bone microarchitecture, but can
be used only at peripheral sites (femur and forearm) and have not yet been incorporated into
standardized clinical imaging protocols due to the lack of central site (lumbar spine)
assessment, where osteoporotic fractures are most prevalent.
The current literature suggests a potential to increase the diagnostic accuracy of
bone-strength prediction by incorporating advanced mathematical descriptors of bone
structure. The project collaborators in Rochester have demonstrated that geometrical features
characterizing the femoral trabecular compartment can complement conventional BMD
measurements and improve bone strength prediction in ex vivo femur specimens. However, little
effort has been made to actually utilize this complementary image information in clinical
practice. This study should encourage the further development of these techniques and
implementation into clinical practice.
Our goal is to start to bridge the gap between fundamental research on bone strength
prediction and clinical management of osteoporosis, reflecting a translational research
approach from "bench to bedside". To this end, a novel methodology will be evaluated by both
a retrospective analysis and a prospective pilot study. The specific choice of using
dual-energy CT (DECT) for the prospective pilot study is motivated by the potential to
improve BMD measurement beyond what Quantitative CT (QCT) can, and it also allows for
material decomposition into calcium and soft-tissue components, which has applications for
other clinically relevant disease entities and will eventually result in the widespread
availability of this relatively new technology.
increased bone fracture risk, which can adversely affect quality of life and increase
age-related morbidity/mortality. The National Osteoporosis Foundation forecast that by 2015,
osteoporosis will be responsible for three million fractures resulting in $25.3 billion in
healthcare costs. This highlights an urgent demand for methods to accurately predict
osteoporotic fracture risk for clinical assessment and management of osteoporosis.
In clinical practice, dual-energy X-ray absorptiometry (DEXA) is the traditional and only
method of diagnosing osteoporosis based on BMD measurements. However, DEXA has certain
limitations, and a considerable overlap exists in BMD values between individuals who develop
fractures and those who do not. This reflects that BMD does not capture all of the factors
that contribute to bone strength. One such factor is trabecular microarchitecture of bone,
well recognized in the definition of osteoporosis.
Ex vivo studies have demonstrated that trabecular bone microarchitecture constitutes an
important component of bone strength, independent of BMD. However, trabecular
microarchitecture is not considered in the evaluation of fracture risk in clinical practice.
Several imaging techniques have been reviewed as potential candidates for clinical evaluation
of trabecular bone microarchitecture. Technological improvements in high resolution X-ray
imaging and MRI are providing increasingly accurate data on bone microarchitecture, but can
be used only at peripheral sites (femur and forearm) and have not yet been incorporated into
standardized clinical imaging protocols due to the lack of central site (lumbar spine)
assessment, where osteoporotic fractures are most prevalent.
The current literature suggests a potential to increase the diagnostic accuracy of
bone-strength prediction by incorporating advanced mathematical descriptors of bone
structure. The project collaborators in Rochester have demonstrated that geometrical features
characterizing the femoral trabecular compartment can complement conventional BMD
measurements and improve bone strength prediction in ex vivo femur specimens. However, little
effort has been made to actually utilize this complementary image information in clinical
practice. This study should encourage the further development of these techniques and
implementation into clinical practice.
Our goal is to start to bridge the gap between fundamental research on bone strength
prediction and clinical management of osteoporosis, reflecting a translational research
approach from "bench to bedside". To this end, a novel methodology will be evaluated by both
a retrospective analysis and a prospective pilot study. The specific choice of using
dual-energy CT (DECT) for the prospective pilot study is motivated by the potential to
improve BMD measurement beyond what Quantitative CT (QCT) can, and it also allows for
material decomposition into calcium and soft-tissue components, which has applications for
other clinically relevant disease entities and will eventually result in the widespread
availability of this relatively new technology.
Inclusion Criteria:
- Age 60 or greater Caucasian female with confirmed osteoporosis via prior DEXA.
- Patients with known vertebral fractures (Genant Grade 2 or higher) and with no
fractures (Genant Score <2) from prior DEXA/VFA analysis will be recruited.
- Patients with fractures must have at least one lumbar vertebral body with no
fracture(s) (as seen on prior DEXA scan) for analysis.
Exclusion Criteria:
- Incidental finding to include pathology unrelated to osteoporosis that would directly
affect bone architecture in the L spine (e.g. lytic bone lesions)
- Study DEXA scan reveals all lumbar vertebra have fractures (Genant >= 2)
- Orthopedic hardware in the lumbar spine region
- Unable to have a CT scan (e.g. too heavy for CT scan table, 660 lb. limit)
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