| Coverage Policy Manual | |
| Policy #: | 2004034 |
| Category: | Radiology |
| Initiated: | July 2004 |
| Last Review: | February 2024 |
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| Screening for Vertebral Fracture with Dual X-ray Absorptiometry (DEXA) | |
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| Description: |
Vertebral fracture assessment (VFA) with densitometry is a technique to assess vertebral fractures at the same time as bone mineral density, using additional software with dual-energy x-ray absorptiometry. The addition of VFA to bone mineral density may augment diagnostic information on fracture risk.
Only 20% to 30% of vertebral fractures are recognized clinically; the rest are discovered incidentally on lateral spine radiographs. Lateral spine radiographs have not been recommended as a component of risk assessment for osteoporosis because of the cost, radiation exposure, and the fact that the radiograph would require a separate procedure in addition to the BMD study using DEXA. However, several densitometers with specialized software are able to perform VFA in conjunction with DEXA. The lateral spine scan is performed by using a rotating arm; depending on the densitometer used, the patient can either stay in the supine position after the bone density study or is required to move onto the left decubitus position.
VFA differs from radiologic detection of fractures because VFA uses a lower radiation exposure and can detect only fractures, while traditional radiograph images can detect other bone and soft tissue abnormalities in addition to spinal fractures. Manufacturers have also referred to this procedure as instant vertebral assessment, radiographic vertebral assessment, dual-energy vertebral assessment, or lateral vertebral assessment.
For both lateral spine radiographs and images with densitometry, vertebral fractures are assessed visually. While a number of grading systems have been proposed, the Genant semiquantitative method is commonly used. This system grades the deformities from I to III, with grade I (mild) representing a 20% to 24% reduction in vertebral height, grade II (moderate) representing a 25% to 39% reduction in height, and grade III (severe) representing a 40% or greater reduction in height. The location of the deformity within the vertebrae may also be noted. For example, if only the midheight of the vertebrae is affected,the deformity is defined as an endplate deformity; if both the anterior and midheights are deformed, it is a wedge deformity; and if the entire vertebrae is deformed, it is classed as a crush deformity. A vertebral deformity of at least 20% loss in height is typically considered a fracture. Accurate interpretation of both lateral spine radiographs and VFA imaging is dependent on radiologic training. Thus, device location and availability of appropriately trained personnel may influence diagnostic accuracy.
Regulatory Status
Additional software is needed to perform VFA with a densitometer, and it must be cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Below is a list of products cleared for marketing. FDA product code KGI.
GEHC DXA Bone Densitometers with enCORE version 18 by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC was cleared on 9/19/2019 for use in vertebral fracture assessment [510(k) no. K191112]
Aria by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC was cleared on 4/20/2018 for use in vertebral fracture assessment [510(k) no. K180782]
GE Lunar DXA Bone Densitometers with enCORE version 17 by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC was cleared on 12/2/2016 for use in vertebral fracture assessment [510(k) no. K161682]
TBS iNsight by MediMaps Group SA was cleared on 4/29/2016 for use in vertebral fracture assessment [510(k) no. K152299]
QCT PRO Asynchronous Calibration Module Cliniqct by Mindways Software Inc. was cleared on 8/29/2014 for use in vertebral fracture assessment [510(k) no. K140342]
Encore Version 16 Software for GE Lunar DXA Bone Densitometers by GE Medical Systems Ultrasound & Primary Care Diagnostics LLC was cleared on 5/15/2014 for use in vertebral fracture assessment [510(k) no. K133664]
Coding
Effective January 1, 2015 the CPT coding for this procedure depends on whether it is performed with a DEXA or not:
77085: Dual-energy X-ray absorptiometry (DXA), bone density study, 1 or more sites; axial skeleton (eg,hips, pelvis, spine), including vertebral fracture assessment
77086: Vertebral fracture assessment via dual-energy X-ray absorptiometry (DXA)
See policy #1997054 for further discussion of measurements of bone mineral density (BMD) as a screening technique for osteoporosis and fracture risk assessment.
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Policy/ Coverage: |
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Screening for vertebral fractures using morphometric absorptiometry (MXA) does not meet member benefit certificate primary coverage criteria that there by scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, screening for vertebral fractures using morphometric absorptiometry (MXA) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
This policy was created in 2004 and was archived in 2012. Most recently, the literature was reviewed through December 2014 and the decision was made to reactivate the policy. Following is a summary of the key literature published to date.
This policy addresses whether screening for vertebral fracture assessment (VFA) using densitometry improves the net health outcome. The ideal study to evaluate improvement in the net health outcome would be a randomized controlled trial (RCT) comparing health outcomes in individuals screened with VFA in addition to dual-energy x-ray absorptiometry (DEXA) compared with those screened with DXA alone. Because no RCTs of this type have been published, an alternative strategy is to examine a chain of indirect evidence. This chain of evidence involves searching for: (1) evidence that VFA is accurate, (2) evidence that VFA identifies appropriate candidates for treatment who would not otherwise be identified, and (3) that treatment in this population is actually beneficial.
The National Osteoporosis Foundation (NOF) 2013 Clinician's Guide to Prevention and Treatment of Osteoporosis recommends considering U.S. Food and Drug Administration (FDA)‒approved medical treatment for the following groups of patients(National Osteoporosis Foundation, 2013):
Because patients with osteoporosis (T-score, ≤-2.5) diagnosed by DEXA and patients with low bone mass and other risk factors for fracture would be treated regardless of vertebral fractures, any incremental benefit using a VFA-inclusive strategy would accrue in the population without osteoporosis. Thus, the literature review will focus on patients who do not have osteoporosis.
In patients without osteoporosis, what is the diagnostic accuracy of VFA with DEXA in identifying vertebral fractures, compared with standard radiographs?
Several recent studies have compared the diagnostic accuracy of VFA and standard radiography. None of these reported findings separately for osteoporotic and nonosteoporotic patients, so conclusions cannot be drawn about diagnostic accuracy of VFA in patients without osteoporosis. Moreover, studies tended to use radiography as the reference standard and did not evaluate potential false positives or false negatives associated with radiography.
In 2013, Domiciano et al reported on 429 adults at least 65 years-old who had VFA with densitometry and spine radiography on the same day (Domiciano, 2013). On VFA, vertebral fractures were identified in 77 of 259 women (29.7%) and 48 of 170 men (28.2%). Comparable numbers on spine radiographs were 74 of 259 (28.6%) in women and 52 of 170 (30.6%) in men. Compared with spine radiography, the sensitivity of VFA was 81.7% (95% confidence interval [CI], 3.9% to 88.1%) and the specificity was 92.7% (95% CI, 9.2% to 95.4%). In 2012, Diacinti et al in Italy published 2 studies comparing the diagnostic accuracy of VFA with standard radiographs (Diacinti, 2012a; Diacinti, 2012b). Neither study, however, reported rates of osteoporosis or reported diagnostic accuracy data in patients without osteoporosis. Both studies found that VFA had high diagnostic accuracy, using conventional radiography as the reference standard. In 1 study, conducted with 930 postmenopausal women, the overall sensitivity and specificity of VFA on a per patient level was 97.23% and 98.86%, respectively. The other study included 350 patients; peri- and postmenopausal women, men referred for diagnosis of osteoporosis, and patients enrolled in a study of HIV-related osteoporosis. When analyzed on a per patient level, VFA was found to have 96.83% sensitivity and 98.66% specificity compared with conventional radiography. The high overall diagnostic accuracy of VFA in these studies suggests that it has high diagnostic accuracy for all BMD levels.
In the newer studies, especially those by Diacinti et al, the accuracy of VFAs was higher than its performance in earlier studies. For example, in 2007 Ferrar et al evaluated the performance of vertebral assessment using a visual algorithm-based approach (Ferrar, 2007). Subjects in the low-risk group were women age 55 to 79 years and were randomly selected from their general practitioners’ offices. Most of them had normal bone mineral density (BMD) or were osteopenic. Subjects in the high-risk group were recruited after a low-trauma fracture to the hip, forearm, or humerus. Most of the high-risk patients had osteopenia or osteoporosis. In per-patient analysis and including all poor or unreadable images, the sensitivity of VFA was 60% in the low-risk group and 81% in the high-risk group; specificity was 97% in both groups. In addition, a 2005 study by Binkley et al compared VFA (GE Lunar densitometer) with radiography in 27 osteoporotic, 38 osteopenic, and 15 normal women.(6) Blinded analysis found correct identification for 17 of 18 radiographically evident grade 2 to 3 fractures (a false negative rate of 6%). The study did not describe whether the grade 2 and 3 fractures were found in women with osteoporosis, osteopenia, or normal BMD. Also, only 11 of 22 (50%) grade 1 fractures were identified. Thirty vertebrae were classified as fractured when no fractures were present (38% false positive), 29 of these were grade 1 fractures by VFA with normal radiography. In addition, VFA identified a total of 40 grade 1 fractures but only 11 (28%) were true positive results. Also problematic is that results were compared only in vertebrae evaluable by VFA; 1 patient could not be evaluated due to poor image quality, and 66% of T4 to T6 vertebrae in other subjects could not be adequately visualized.
Section summary
Several studies have compared VFA with radiography. The sensitivity of VFA compared with standard radiography reported in these studies was variable. Studies published in 2012 and 2013 reported higher diagnostic accuracy than older studies, ie, sensitivities in the 80% to 99% range and specificities over 90%. However, these recent studies did not to present diagnostic accuracy rates separately for patients without osteoporosis. Because of the lack of stratified analyses, it is not possible to determine the sensitivity and specificity of VFA for vertebral fractures with certainty for the subset of patients without osteoporosis.
Does vertebral assessment identify candidates for treatment who would not otherwise be identified?
As previously stated,(National Osteoporosis Foundation, 2013) the 2013 NOF guidelines recommend treating patients with osteoporosis, with osteopenia and other risk factors and those with hip or vertebral fractures (clinical or asymptomatic). Vertebral fracture assessment could identify additional candidates for treatment if patients with vertebral fractures did not fall into one of the other categories eligible for treatment. No studies were identified that specifically dealt with the question of whether VFA would identify candidates for medication treatment who would not otherwise have been identified, but several studies addressed this issue to some extent. Representative studies with larger sample sizes are described next.
A 2014 study by Kanterewiez et al in Spain collected data on a population-based cohort of 2968 postmenopausal women between the ages of 59 and 70 years (Kamterewiez, 2014). A total of 127 women (4.3%) had a vertebral fracture according to VFA. Among these, 48.0% had osteoporosis and 42.5% had osteopenia. Moreover, 42.5% had previous fragility fractures and 34.6% had a first-degree family history of fractures. Thus, VFA could potentially identify additional women who would be eligible for fracture prevention therapy according to NOF guidelines (ie, women who did not have osteoporosis, osteopenia plus a 10-year fracture risk, or other risk factors). The authors did not attempt to define this subgroup eg, they did not report data on women with normal BMD and other risk factors.
In 2013, Mrgan et al in Denmark published a retrospective study evaluating VFA with BMD in 3275 patients presenting for osteoporosis screening or evaluation of antiosteoporotic medication; 85% were female (Mrgan, 2013). Vertebral fractures were found on VFA in 260 patients (7.9%). Of these, 156 patients (4.8% of the total sample) had osteoporosis (ie, BMD at least -2.5) and 104 (3.2% of the total sample) did not have osteoporosis, according to BMD. The data suggest that up to 40% (104/250) patients with vertebral fractures identified would be eligible for treatment according to NOF guidelines, and might not have been identified if DEXA alone were used. Some of the patients, however, may have had osteopenia and other risk factors that would lead to their eligibility for treatment.
In 2011, Jager et al reported on 2424 consecutive patients (65% were female) referred for BMD for a variety of reasons at a single center in the Netherlands (Jager, 2011). Participants underwent VFA with BMD during the same session. Vertebral fractures (reduction in height of at least 20%) were detected in a total of 541 (22%) of patients. The prevalence of vertebral fractures was 14% (97/678) in patients with normal BMD and 21% (229/1100) in patients with osteopenia. Thus, 60.5% (326/541) of the patients with vertebral fracture did not have osteoporosis and could be eligible for treatment based on the 2013 NOF guidelines if they did not fall into another eligibility category, eg, osteopenia with other risk factors. Most of the fractures had not been identified in the past. The vertebral fractures were previously unknown in 74% of patients with normal BMD and 71% of patients with osteopenia.
Section summary
Routine use of VFA with DEXA will identify substantial numbers of patients with previously unrecognized vertebral fractures. Many of these vertebral fractures are found in patients without osteoporosis. Data are not available on how many of the vertebral fractures in nonosteoporotic patients were in patients who would not otherwise be eligible for treatment, ie, those with osteopenia and other risk factors for fracture.
Does pharmacologic treatment in patients with vertebral fracture and low bone mass improve health outcomes?
Bisphosphonates decrease bone resorption and are the major class of drugs now used to treat osteoporosis.
Several subgroup analyses of large RCTs evaluating the efficacy of bisphosphonates in patients with low bone mass and/or baseline vertebral fractures have been published. The trials were not designed a priori to assess efficacy according to baseline vertebral fracture status or BMD categories. The Fracture Intervention Trial (FIT) study group was the first large multicenter study comparing the effects of treatment between osteoporotic women and women with low bone mass without existing vertebral fractures using the revised National Health and Nutrition Examination Survey (NHANES) cutoffs (Cummings, 1998). This trial randomly assigned 4432 women to alendronate or placebo and analyzed the treatment group in 3 BMD categories (<-2.5 SD, -2.0 to -2.5 SD; -1.6 to -2.0 SD below the mean). Women with a BMD less than -2.5 SD had a statistically significant reduction in clinical and vertebral fractures over 4 years. The relative risk (RR) for all clinical fractures among patients with a BMD less than -2.5 SD was 0.6 (95% CI, 0.5 to 0.8). There was no significant reduction in all clinical fractures for women with higher BMD values (RR=1.1; 95% CI, 0.9 to 1.4), suggesting no benefit among patients with low bone mass or normal BMD.
Quandt et al reanalyzed the FIT study analyzing data for the outcome of both clinical vertebral fractures (symptomatic and diagnosed by physician) and radiographically detected (assessed at surveillance intervals) vertebral fractures (Quandt, 2005). A total of 3737 women at least 2 years postmenopausal with low bone mass (T-score between -1.6 and -2.5) were included in the analysis. Among the women with low bone mass and existing radiographically detected vertebral fractures (n=940), the rate of subsequent clinical vertebral fractures were 6 (a rate of 43/10,000 person-years of risk) in the alendronate group and 16 (124/10,000 person-years of risk) in the placebo group. Alendronate treatment compared with placebo was accompanied by a RR of 0.3 (95% CI, 0.1 to 0.8) for clinical vertebral fractures and a RR of 0.5 (95% CI, 0.3 to 0.8) for radiographically detected fractures. Similar RR estimates were found for women having
low bone mass without vertebral fractures, but absolute risks were lower (12 vs 81 fractures/10,000 person-years for those without and with baseline fractures, respectively).
Kanis et al reanalyzed data on 1802 women at least 5 years postmenopausal from the Vertebral Efficacy with Risedronate Therapy (VERT) trials who were identified on the basis of a prior radiographically detected vertebral fracture regardless of BMD and had radiographs available at baseline and 3 years (Kanis, 2005). Overall, there was a significantly lower rate of a new vertebral fracture in women with prior vertebral fracture randomly assigned to treatment with risedronate compared with placebo (14.5% vs 22.3%, respectively; p<0.001). In the group with a T-score greater than -2.5, the rate of new femoral neck fractures was 50 of 519 (11%) in the risedronate group and 71 of 537 (15.5%) in the placebo group (p=0.049). In the osteoporotic group, those with a T-score of -2.5 or lower, the rate of new femoral neck fracture was 53 of 355 (18.7%) in the risedronate group and 92 of 318 (33.4%) in the placebo group
(p<0.001). Findings were similar when the T-score at the most severe skeletal site (femoral neck or lumbar spine) was used for stratification.
Section summary
Evidence from the FIT and VERT studies suggests that treatment of patients with low bone mass (but not osteoporosis) reduces further fractures. However, a limitation of the FIT and VERT studies is that they are post hoc subgroup analyses, which are generally considered to be exploratory. In addition, vertebral fracture screening was done using radiography rather than VFA software. Advantages of the studies are that the 2 subanalyses had large sample sizes and used data from well-conducted randomized trials. This evidence is insufficient to determine whether treatment of patients with low bone density and vertebral fractures improves outcomes.
Does VFA improve outcomes in men who are being evaluated for osteoporosis?
No RCTs were identified that evaluated the efficacy of bisphosphonate treatment in men with vertebral fractures and low bone density. Several trials have evaluated whether bisphosphonate treatment increases BMD in men at risk for bone loss, eg, on androgen deprivation therapy (Bhoopalam, 2009; Greenspan, 2007). However, vertebral fractures were not assessed, and therefore conclusions cannot be drawn about the potential added benefit of VFA in addition to densitometry in at-risk men.
Summary
There is a lack of direct evidence from screening trials comparing densitometry with and without vertebral fracture assessment (VFA) that VFA improves health outcomes. Because direct evidence was not available, a causal chain of indirect evidence was examined. Evidence was examined on the diagnostic accuracy of VFA in nonosteoporotic patients, the ability of VFA to identify patients for treatment who would not otherwise be identified, and the effectiveness of treatment in this population. Diagnostic accuracy studies had variable findings; recent studies suggest higher diagnostic accuracy of VFA overall compared with standard radiographs. Even in recent studies, however, diagnostic accuracy data in patients without osteoporosis were not reported separately.
Studies have found that VFA can identify patients without osteoporosis who may be appropriate candidates for treatment according to recommendations from the National Osteoporosis Foundation (NOF). However, there is limited evidence on the effectiveness of treatment in this population. No trials have been published that were designed to evaluate whether treating patients with vertebral fracture and without osteoporosis reduces risk of future fracture. The available data on treatment are 2 post-hoc subanalyses from larger trials that included patients with low bone density and baseline vertebral fractures with medication versus placebo; both found a benefit of treatment. Baseline vertebral fracture was defined differently in the 2 analyses; clinical or radiographically detected vertebral fracture in 1 study and radiographically detected vertebral fracture-only in the other. No treatment data have been published in patients whose vertebral fracture had been identified using VFA software with densitometry. Moreover, data on clinical utility are only available on postmenopausal women. In addition, clinical input was not uniformly in support of VFA.
Practice Guidelines and Position Statements
NOF: Their 2013 Clinician's Guide to Prevention and Treatment of Osteoporosis stated: “A vertebral fracture is consistent with a diagnosis of osteoporosis, even in the absence of a bone density diagnosis, and is an indication for pharmacologic treatment with osteoporosis medication to reduce fracture risk. Most vertebral fractures are asymptomatic when they first occur and often are undiagnosed for many years. Proactive vertebral imaging is the only way to diagnose these fractures. The finding of a previously unrecognized vertebral fracture may change the diagnostic classification, alters future fracture risk and subsequent treatment decisions” (National Osteoporosis Foundation, 2013).
The guide recommends that vertebral imaging tests be considered in the following patients
· All women age 70 and older and all men age 80 and older.
· Women age 65 to 69 and men age 75 to 79 when BMD T-score is -1.5 or below.
· Postmenopausal women age 50 to 64 and men age 50 to 69 with specific risk factors These
include:
International Society for Clinical Densitometry (ISCD): In 2013, ISCD issued updated recommendations for selecting patients for VFA (Rosen, 2013). The new recommendations were simpler compared to the 2007 recommendations and were intended to be easier to use in clinical practice. Lateral spine imaging with either standard radiography or densitometric VFA is indicated for patients with a T-score of less than -1.0 when at least 1 of the following factors are present:
A 2012 Task Force of the Endocrine Society recommended pharmacologic therapy for men at high risk for fracture (Endocrine Society Osteoporososis in Men, 2012). Risk includes but is not limited to the following criteria:
North American Menopause Society: Their 2010 position statement on management of osteoporosis does not include a recommendation for or against vertebral fracture assessment as part of the screening process (North American Menopause Society, 2010). The statement states that vertebral fracture must be confirmed by lateral spine radiographs or VFA visualization of fracture at the time of BMD testing.
U.S. Preventive Services Task Force: In January 2011, USPSTF updated their recommendations for osteoporosis screening. The recommendations state that “current diagnostic and treatment criteria rely on dual-energy x-ray absorptiometry of the hip and lumbar spine.” Vertebral fracture assessment was not specifically mentioned (USPSTF, 2011).
2016 Update
A literature search conducted through December 2015 did not reveal any new information that would prompt a change in the coverage statement.
2017 Update
A literature search conducted through December 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
The National Osteoporosis Foundation (NOF) 2014 Clinician's Guide to Prevention and Treatment of Osteoporosis recommends considering U.S. Food and Drug Administration (FDA)‒approved medical treatment for the following groups of patients (Cosman, 2014):
A systematic review of studies was published by Lee and colleageus (Lee, 2016). They included studies with postmenopausal women and/or men 50 years and older that compared the diagnostic accuracy of VFA with DXA and spinal radiography. Seventeen studies met the inclusion criteria; 5 were excluded because of inadequate description of methods or results. Of the remaining 12 studies, 4 examined postmenopausal women, 5 included osteoporotic patients (men and women), and 2 included both populations. Studies were heterogeneous and thus the reviewers did not pool study findings. Among the 8 studies that reported findings on a per-vertebral level, sensitivity of VFA with DXA ranged from 70% to 93% and specificity ranged from 95% to 100%. Nine studies reported findings on a per-patient level. Sensitivity ranged from 65% to 100% and specificity from 74% to 100%. The systematic review did not report separate analyses of the diagnostic accuracy of VFA with DXA in osteoporotic versus nonosteoporotic patients.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
PRACTICE GUIDELINES AND POSITION STATEMENTS
American Association of Clinical Endocrinologists and American College of Endocrinology
The 2016 joint guidelines from the American Association of Clinical Endocrinologists and American College of Endocrinology on the diagnosis and treatment of postmenopausal menopause included the following recommendation on VFA (Camacho, 2016). Their joint recommendations are similar to those of the International Society for Clinical Densitometry in 2013.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
International Society for Clinical Densitometry
The International Society for Clinical Densitometry updated its recommendations for selecting patients for vertebral fracture assessment (VFA) (Rosen, 2013); these recommendations were largely unchanged in a 2015 update (ISCD, 2015). Lateral spine imaging with either standard radiography or densitometric VFA is indicated for patients with a T score of less than -1.0 when at least 1 of the following factors are present:
U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force updated its recommendations on screening for osteoporosis to prevent fractures (USPSTF, 2018;USPSTF, 2018). The recommendations included: “Most treatment guidelines recommend using BMD, as measured by central DXA, to define osteoporosis and the treatment threshold to prevent osteoporotic fractures.” Peripheral DXA and quantitative ultrasound are also described as common bone measurement screening tests for osteoporosis. VFA was not specifically mentioned.
2020 Update
A literature search was conducted through January 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Malgo et al compared VFA with DXA to conventional spine radiography and published evidence comparing VFA with DXA to conventional spine radiography from a fracture liaison service (FLS) and meta-analysis of comparative studies (Malgo, 2017). The FLS retrospective diagnostic study included 542 consecutive subjects (25% male) aged 50 years or older assessed for vertebral fractures and osteoporosis between 2012 and 2014 with both VFA and conventional radiography. The diagnostic accuracy of VFA was calculated using conventional radiography as reference, and observers were blinded to the VFA findings. Normal BMD was reported in 11% of subjects. The sensitivity of VFA with DXA to detect a vertebral fracture greater or equal to Genant grade 2 was 77% and its specificity was 80%. A meta-analysis of 16 studies including 3238 subjects (19% male) with low to intermediate risk of bias revealed a pooled sensitivity of 84% (95% CI, 72% to 92%) and specificity of 90% (95% CI, 84% to 94%). Reviewers did not report separate analyses for the diagnostic accuracy of VFA with DXA in patients at low- vs high-risk of osteoporosis. While the meta-analysis suggests adequate diagnostic performance of VFA with DXA for the detection of vertebral fractures, the study authors caution that these findings could not be replicated in their FLS center.
Yang et al conducted a systematic review and meta-analysis of 28 studies evaluating detection of vertebral fractures via VFA with DXA in asymptomatic postmenopausal women (Yang, 2020). Study sample sizes ranged from 63 to 5,156 and mean age ranged from 59.5 to 86.2 years. Among women who had prevalent vertebral fractures,11.1-43% had osteopenia and 3.6-32% had normal BMD. The weighted pool prevalence of VFA-detected vertebral fractures was 28% (95% CI, 23% to 32%) with a high degree of heterogeneity (I2 = 98.89%; P < 0.001). A separate subgroup analysis for women with normal bone density was not conducted.
El Maghraoui et al published a prospective study evaluating VFA with BMD in 791 asymptomatic men aged between 45 and 89 years with no prior osteoporotic fracture or known diagnosis of osteoporosis in Morocco (El Maghraoui, 2012). In men with normal BMD, a grade 1-3 vertebral fracture was identified in 85/262 (32.4%) men. Grade 2-3 vertebral fractures were identified in 6.9% of these subjects. Vertebral fractures were also identified in 144/402 (35.8%) men with osteopenia (11.7% grade 2-3) and 89/124 (71.8%) men with osteoporosis (37.9% grade 2-3). Stepwise regression analysis indicated that prevalence of vertebral fractures was independently related to osteoporotic (OR = 4.761; 95% CI, 2.956 to 7.668) and smoking status (OR = 1.717; 95% CI, 1.268 to 2.323).
A similar study by El Maghraoui et al in 908 asymptomatic postmenopausal women aged between 50 and 91 years identified vertebral fractures in 63 (28.3%) women with normal BMD (8.5% grade 2-3) (El Maghraoui, 2013). Stepwise regression analysis indicated that the presence of vertebral fractures was independently related to age, low BMI, multiparity, history of peripheral fracture, and low BMD. It is unclear whether patients were consecutively enrolled in the El Maghraoui studies.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In its 2022 clinician's guide, the Bone Health and Osteoporosis Foundation, formerly the National Osteoporosis Foundation, recommends to consider initiating pharmacologic treatment in (LeBoff, 2022):
Because patients with osteoporosis (T score, ≤ -2.5) diagnosed by DXA and patients with low bone mass and other risk factors for fracture would be treated regardless of vertebral fractures, any incremental benefit using a VFA-inclusive strategy would accrue in the population without osteoporosis.
The Bone Health and Osteoporosis Foundation, formerly the National Osteoporosis Foundation, published an updated clinician's guide to the prevention and treatment of osteoporosis in 2022 (LeBoff, 2022). Per the guide, "a vertebral fracture in an adult ≥ 50 years is diagnostic of osteoporosis, even in the absence of a bone density diagnosis. Unfortunately, most vertebral fractures are subclinical or completely asymptomatic. As a result, they may go undiagnosed for many years. At the same time, a high proportion of women with asymptomatic vertebral fractures have BMD levels that would not warrant treatment based on bone mineral density (BMD) alone. The finding of a previously unrecognized vertebral fracture may change a patient's diagnostic classification, alter fracture risk calculations, and determine treatment decisions. Proactive investigation is required to detect these fractures so that further bone damage can be prevented."
Traditionally, conventional lateral thoracic/lumbar spine X-ray has been considered the gold standard for identification of vertebral fractures; however, the guide notes that "DXA-assisted VFA is emerging as an alternative to radiograph for its convenience, low cost, and minimal radiation exposure" (LeBoff, 2022). The guide recommends that in order to "to detect subclinical vertebral fractures," clinicians should perform vertebral fracture imaging (X-ray or DXA VFA) in the following:
The North American Menopause Society updated its position statement on the management of osteoporosis in postmenopausal women in 2021 (McClung, 2021). The Society states that in order to identify asymptomatic compression vertebral fractures, "evaluation by a lateral thoracolumbar radiograph or VFA by DXA" may be utilized.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Only 20% to 30% of vertebral fractures are recognized clinically; the rest are discovered incidentally on lateral spine radiographs or other imaging studies (Alsoof, 2022). Lateral spine radiographs have not been recommended as a component of risk assessment for osteoporosis because of the cost, radiation exposure, and the fact that the radiograph would require a separate procedure in addition to the bone mineral density (BMD) study using dual-energy x-ray absorptiometry (DXA). However, several densitometers with specialized software can perform vertebral fracture assessment (VFA) in conjunction with DXA. The lateral spine scan is performed by using a rotating arm. Depending on the densitometer used, the patient can either stay in the supine position after the bone density study or is required to move to the left decubitus position.
Updated appropriateness criteria was published for osteoporosis and bone mineral density(BMD) in 2022 (American College of Radiology, 2022), DXA VFA is not mentioned among imaging studies in patients undergoing osteoporosis screening or initial imaging of clinically suspected low BMD. For follow-up imaging of patients demonstrated to have risk for fracture or surveillance of established low BMD, DXA VFA is usually not appropriate by ACR criteria. Conversely, for follow-up imaging of patients with T-scores less than -1.0 by DXA, DXA VFA is usually appropriate by ACR criteria in patients who meet 1 or more of the following criteria:
A single-center retrospective study was published of adults who underwent DXA with VFA for any reason over a 1-year period (Gill, 2023). The authors identified 479 eligible scans; 54 patients (11%) had a vertebral fracture, of which 47 (10%) were previously undiagnosed. Among patients with new vertebral fractures, approximately 23% had normal BMD, while approximately40% and 36% met BMD criteria for osteopenia or osteoporosis, respectively. The mean 10-year probability of major osteoporotic or hip fractures when calculated via FRAX without a documented history of fracture (i.e., prior to detection of vertebral fracture)was 7.1% and 2.8%, respectively; when recalculated to incorporate the detected vertebral fracture, these probabilities increased to 12.4% and 4.8%, respectively (p<.01 for each). Indications for DXA with VFA were not reported.
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| References: |
Domiciano DS, Figueiredo CP, Lopes JB et al.(2013) Vertebral fracture assessment by dual X-ray
absorptiometry: a valid tool to detect vertebral fractures in community-dwelling older adults in a
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