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Protocol - Vertebral Fracture Assessment (VFA)

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Description

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.

Specific Instructions

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

Protocol

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

Availability

Available

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 CategoryRequired
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
StandardNameIDSource
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 IDVariable DescriptiondbGaP 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

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

Measure Protocols
Protocol ID Protocol Name
172101 Vertebral Fracture Assessment (VFA)
Publications

There are no publications listed for this protocol.