Protocol - Vertebral Fracture Assessment (VFA)
The morphometric Vertebral Fracture Assessment (VFA) protocol describes semi-qualitative method of grading vertebral fracture DXA images. Descriptions of grades 0 thru 3 are included.
Note: Manufacturers of DXA equipment are constantly striving to improve and update both their equipment and software with the latest technological advances. Hence, please refer to the DXA specifications for your model number to ensure that the level of information collected is compatible with the PhenX protocol.
DXA measurement is complex and requires costly hardware, specialized software to analyze the DXA scans, rigorous quality control, specialized examiners, continuous equipment calibration and monitoring, and scan quality control monitoring.
This protocol provides guidance on interpretation and reading of a DXA image. Guidance for obtaining those images can be found in the PhenX protocol - Spine and Femur Bone Density by Dual-Energy X-ray Absorptiometry
This protocol measures Vertebral Fracture based on manual or automated (on DXA) Vertebral Height Ratios
Assessing Vertebral Fracture (VFx) from Images
Investigator to review vertebral fracture DXA images and ascertain grading based on the following:
- Grade 0 - Normal, unfractured vertebra
- Grade 1 - Mild fracture with 20-25% reduction in anterior, middle or posterior heights relative to the same adjacent vertebrae
- Grade 2 - Moderate fracture with 25-40% reduction in anterior, middle or posterior heights relative to the same adjacent vertebrae
- Grade 3 - Severe fracture with >40% reduction in anterior, middle or posterior heights relative to the same adjacent vertebrae
Personnel and Training Required
Technicians may or may not be certified radiology technologists depending on state laws. Regardless of formal education, study personnel should receive specialized training in the survey protocol and basic techniques of the operation of the specific make and model of the dual-energy X-ray absorptiometry machine used. Device-specific education and training should be provided to the operators and interpreters prior to clinical use. Quality control procedures should be performed regularly.
Several dual-energy X-ray absorptiometry (DXA) machines are marketed commercially. According to the International Society for Clinical Densitometry (2019), “Bone density measurements from different devices cannot be directly compared.” Because there are a couple of different manufacturers and several models and software versions of the DXA machine, the investigator should report those they are using. Regular scans (i.e., weekly at a minimum for large studies) using DXA phantoms are recommended as an independent assessment of system calibration. Studies that use more than one scanner device should also implement a plan to monitor inter-scanner differences at baseline and at regular intervals during the study.
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Noninvasive radiologic assessment
Adults ages 18 years and older
Vertebral fracture assessment (VFA) is used in almost all pharmacologic studies; the FDA requires VFx as the primary endpoint for drug approval.
|caDSR Common Data Elements (CDE)||Vertebral Fracture Assessment||11136934||CDE Browser|
Process and Review
Protocol Name from Source
Vertebral Fracture: Lateral Spine DXA or X-ray
Lems, W. F., Paccou, J., Zhang, J., Fuggle, N. R., Chandran, M., Harvey, N. C., … International Osteoporosis Foundation Fracture Working Group. (2021). Vertebral fracture: Epidemiology, impact and use of DXA vertebral fracture assessment in fracture liaison services. Osteoporosis International, 32(3), 399–411. https://doi.org/10.1007/s00198-020-05804-3
De Franceschi, L., Gabbiani, D., Giusti, A., Forni, G., Stefanoni, F., Pinto, V. M., … Carbonare, L. D. (2020). Development of algorithm for clinical management of sickle cell bone disease: Evidence for a role of vertebral fractures in patient follow-up. Journal of Clinical Medicine 9(5), 1601. https://dx.doi.org/10.3390%2Fjcm9051601
Genant, H. K., Wu, C. Y., van Kujik, C., & Nevitt, M. C. (1993). Vertebral fracture assessment using a semiquantitative technique. Journal of Bone Mineral Research, 8(9), 1137–1148. https://doi.org/10.1002/jbmr.5650080915
International Society for Clinical Densitometry. (2019). 2019 ISCD Official Positions: Adult. Retrieved from https://iscd.org/learn/official-positions/adult-positions/.
Serarslan, Y., Kalaci, A., Özkan, C., Do?ramaci, Y., Çokluk, C., & Yanat, A. N. (2010). Morphometry of the thoracolumbar vertebrae in sickle cell disease. Journal of Clinical Neuroscience, 17(2), 182–186. https://doi.org/10.1016/j.jocn.2009.05.010
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX172101020400||For postmenopausal women: do you have a BMD more||N/A|
|PX172101020300||For postmenopausal women: have you had more||N/A|
|PX172101020100||For postmenopausal women: have you had a more||N/A|
|PX172101020500||For postmenopausal women: do you have a more||N/A|
|PX172101020200||For postmenopausal women: do you have kyphosis?||N/A|
|PX172101010300||For women age 70 years or more or for men more||N/A|
|PX172101010100||For women age 70 years or more or for men more||N/A|
|PX172101010200||For women age 70 years or more or for men more||N/A|
|PX172101040000||Dual-energy x-ray absorptiometry (DXA) more||N/A|
|PX172101050000||Dual-energy x-ray absorptiometry (DXA) more||N/A|
|PX172101030304||For postmenopausal women and men age 50 and more||N/A|
|PX172101030302||For postmenopausal women and men age 50 and more||N/A|
|PX172101030303||For postmenopausal women and men age 50 and more||N/A|
|PX172101030301||For postmenopausal women and men age 50 and more||N/A|
|PX172101030200||For women between ages 65 and 69 years or more||N/A|
|PX172101030100||For women age 70 years or more or for men more||N/A|
Vertebral Fracture Assessment (VFA)
October 21, 2022
Vertebral Fracture Assessment (VFA) is a measurement that can be obtained from lateral spine dual-energy X-ray absorptiometry (DXA) scans and can be used to diagnose a vertebral fracture. Alternatively, vertebral fractures can be assessed from lateral spine radiographs.
Diagnosis of vertebral fracture is a strong predictor of risk of vertebral and other osteoporotic fractures. It has an important role in clinical decision-making for osteoporosis treatment and prevention. VFA is a convenient and widely available technology to assess vertebral fractures.
vertebral fracture assessment (vfa), bone mineral density, BMD, epidemiology, osteoporosis, arthritis, dual-energy X-ray absorptiometry, DXA, X-rays, radiograph, body composition, bone density, dual-energy X-ray absorptiometry, DEXA, osteoporosis, osteopenia, aging, geriatrics, bone, joint, International Osteoporosis Foundation, IOF
|Protocol ID||Protocol Name|
|172101||Vertebral Fracture Assessment (VFA)|
There are no publications listed for this protocol.