Protocol - Vertebral Fracture Assessment (VFA)

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.

Equipment Needs

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.

Requirements

Requirement Category	Required
Major equipment	Yes
Specialized training	Yes
Specialized requirements for biospecimen collection	No
Average time of greater than 15 minutes in an unaffected individual	No

Mode of Administration

Noninvasive radiologic assessment

Lifestage

Adult, Senior

Participants

Adults ages 18 years and older

Selection Rationale

Vertebral fracture assessment (VFA) is used in almost all pharmacologic studies; the FDA requires VFx as the primary endpoint for drug approval.

Language

English

Standards

Standard	Name	ID	Source

Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

Vertebral Fracture: Lateral Spine DXA or X-ray

Source

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

General References

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/.

Email iscd@iscd.org

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 

Protocol ID

172101

Variables

Export Variables

Variable Name	Variable ID	Variable Description	dbGaP Mapping
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_IOF_ESCEO_Post_Menopausal_BMD
	PX172101020400	For postmenopausal women: do you have a BMD more T-score of less than or equal to -2.5? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_IOF_ESCEO_Post_Menopausal_Glucocorticoid_Therapy
	PX172101020300	For postmenopausal women: have you had more recent or are you undergoing long-term oral glucocorticoid therapy? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_IOF_ESCEO_Post_Menopausal_Height_Loss
	PX172101020100	For postmenopausal women: have you had a more history of 4 cm or more height loss? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_IOF_ESCEO_Post_Menopausal_History
	PX172101020500	For postmenopausal women: do you have a more history of non-vertebral fracture? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_IOF_ESCEO_Post_Menopausal_Kyphosis
	PX172101020200	For postmenopausal women: do you have kyphosis?	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_ISCD_Women_70_Men_80_Glucocorticoid_Therapy
	PX172101010300	For women age 70 years or more or for men more age 80 years or more: have you had glucocorticoid therapy equivalent to 5 mg or more of prednisone or equivalent per day for 3 months or more? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_ISCD_Women_70_Men_80_Height_Loss
	PX172101010100	For women age 70 years or more or for men more age 80 years or more: have you had a height loss of 4 cm or more? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_ISCD_Women_70_Men_80_Prior_Self_Report
	PX172101010200	For women age 70 years or more or for men more age 80 years or more: have you had a prior vertebral fracture? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_Machine_Name
	PX172101040000	Dual-energy x-ray absorptiometry (DXA) more machine name show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_Manufacturer
	PX172101050000	Dual-energy x-ray absorptiometry (DXA) more manufacturer show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_NOF_Postmenopausal_Women_Men_50_Glucocorticoid_Treatment
	PX172101030304	For postmenopausal women and men age 50 and more older: have you had recent or ongoing long-term glucocorticoid treatment? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_NOF_Postmenopausal_Women_Men_50_Height_Loss_History
	PX172101030302	For postmenopausal women and men age 50 and more older: have you had a height loss of 1.5 inches or more (4 cm) since age 20? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_NOF_Postmenopausal_Women_Men_50_Height_Loss_Prospective
	PX172101030303	For postmenopausal women and men age 50 and more older: have you had a height loss of 0.8 inches or more (2 cm) since last measuring your height? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_NOF_Postmenopausal_Women_Men_50_Low_Trauma
	PX172101030301	For postmenopausal women and men age 50 and more older: have you had low-trauma fracture during adulthood (age 50+)? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_NOF_Women_65_69_Men_70_79
	PX172101030200	For women between ages 65 and 69 years or more for men between ages 70 and 79 years: do they have a BMD T-score less than or equal to -1.5 at the spine, total hip, or femoral neck? show less	N/A
PX172101_Vertebral_Fracture_Lateral_Spine_DXA_Xray_NOF_Women_70_Men_80
	PX172101030100	For women age 70 years or more or for men more age 80 years or more: do they have a BMD T-score less than or equal to -1 at the spine, total hip, or femoral neck? show less	N/A

Bone and Joint

Measure Name

Vertebral Fracture Assessment (VFA)

Release Date

October 21, 2022

Definition

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.

Purpose

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.

Keywords

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

Measure Protocols

Protocol ID	Protocol Name
172101	Vertebral Fracture Assessment (VFA)

Publications

There are no publications listed for this protocol.