Vertebral Fracture Assessment: The 2005 ISCD Official Positions
Article Outline
- Abstract
- Introduction
- Methodology
- I. Vertebral Fracture Assessment Nomenclature
- Rationale & Discussion
- II. Indications for VFA
- Rationale
- Discussion
- IV. Method for Defining and Reporting Fractures on VFA
- Rationale & Discussion
- V. Indications for Following VFA with Another Imaging Modality
- Rationale & Discussion
- VI. Components of a VFA Report
- Rationale
- In Summary
- Acknowledgments
- References
- Copyright
Abstract
Vertebral Fracture Assessment (VFA) is a low radiation method for imaging the thoraco-lumbar spine using bone densitometers. VFA can easily be performed at the time of bone mineral density (BMD) measurement, allowing integration of BMD and vertebral fracture information into clinical patient care. As VFA is a relatively new procedure, it has received limited study and heretofore has not had widespread clinical application. Consequently, the International Society for Clinical Densitometry (ISCD) considered the following VFA issues at the 2005 Position Development Conference: (1) indications for VFA; (2) methodology for the diagnosis of vertebral fractures using VFA; and (3) indications for additional imaging after VFA. The ISCD Official Positions with respect to the above issues, as well as the rationale and evidence used to derive these positions, are presented here.
Key Words: Vertebral fracture Assessment, VFA, fracture, dual-energy X-ray absorptiometry, imaging, position, guideline
Introduction
Vertebral fractures are common 1, 2, 3, 4, 5, 6, 7 yet often unrecognized clinically, with only about one third of vertebral fractures found on radiographs coming to clinical attention (8). Yet the presence of prior vertebral fractures, even those that are not diagnosed clinically, is a significant risk factor for future vertebral, and to a lesser degree non-vertebral, fractures 9, 10, 11, 12, 13. Thus, finding vertebral fractures identifies patients with increased skeletal fragility. Because of this, the National Osteoporosis Foundation (NOF) has recommended that the presence of vertebral fractures, unless they result from trauma or pathologic process, be considered diagnostic of osteoporosis and treated aggressively (14). Furthermore, the presence of vertebral fractures increases fracture risk independent of bone mineral density (BMD) (15). Thus, concurrent information on bone mass and vertebral fracture status aids clinicians in stratifying fracture risk and evaluating the need for osteoporosis therapy. Since diagnosing vertebral fractures has traditionally required radiographs, which are often not obtained when evaluating patients for osteoporosis, many of these fractures are not discovered and not considered when selecting patients for treatment.
Vertebral fracture assessment (VFA) is a method for imaging the thoraco-lumbar spine using bone densitometers (16). It can easily be performed at the time of BMD measurement, allowing integration of BMD and vertebral fracture information in the clinical care of patients evaluated for osteoporosis. VFA is associated with low radiation exposure (3 μSv vs. 600 μSv for spine radiographs), and can be obtained within seconds or minutes during a densitometry examination. However, VFA is a relatively new procedure which has received limited evaluation in research studies 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and has previously not been widely used in clinical settings.
Theoretically, this new method of spine imaging could be offered to all patients who present for densitometry; however, several areas of uncertainty exist regarding the clinical application of VFA. Importantly, it is necessary to establish which patients should receive VFA in order to identify those with vertebral fractures, while minimizing testing of individuals who do not have vertebral fractures. Additionally, it is not clear which methodology is best to utilize for diagnosis of vertebral fractures using VFA. This is not surprising, as even for spine radiographs, which have been the ‘gold standard’ to identify vertebral fracture for many years, there is continuing debate regarding the relative merits of visual versus morphometric assessment, or different combinations of the two 9, 30, 31, 32, 33, 34, 35, 36. Finally, due to its lower resolution, VFA does not provide the image quality of conventional radiography. Consequently, in some instances, VFA is not able to precisely characterize some vertebral fractures or other bone and soft tissue abnormalities. In these situations other imaging examinations may be needed to clarify the VFA findings: however, the VFA findings necessitating further imaging have not been adequately defined.
Methodology
The methods used to develop, and grading system applied to these ISCD Official Positions, are presented in the Executive Summary that accompanies this paper. In brief, all Positions were graded on quality of evidence (good, fair, poor), strength of the recommendation (A, B, or C, where A is a strong recommendation supported by the evidence, B is a recommendation supported by the evidence, and C is a recommendation supported primarily by expert opinion), and applicability (worldwide or variable according to local requirements).
I. Vertebral Fracture Assessment Nomenclature
ISCD Official Position
Rationale & Discussion
Vertebral Fracture Assessment, with the acronym VFA, is the preferred designation for this procedure. Several other terms have previously been used in the literature, including vertebral absorptiometry or MXA (morphometric x-ray absorptiometry) 17, 18, 20, 21, 22, 23, 24, 25, 29, 37, 38, Instant Vertebral Assessment (IVA) (19), Radiographic Vertebral Assessment (RVA), Lateral Vertebral Assessment (LVA) (28), Dual-energy Vertebral Assessment (DVA) (27) and others. IVA and RVA are terms specific to different versions of Hologic instruments, while LVA and DVA are used for different versions of GE Healthcare Lunar densitometers. The use of multiple terms to describe the same test has resulted in confusion in the literature, and among practitioners receiving VFA reports or contemplating adding this technology to their densitometry practice.
The rationale for this recommendation is that a universal term should be used for describing this methodology rather than continually changing the nomenclature as densitometry technology evolves. Using multiple terms for the same general technique brings uncertainty to the field and may impair clinical care, education and research. An analogous example in the bone field is the prior use of the abbreviations DXA and DEXA for dual-energy X-ray absorptiometry (DXA is the current preferred designation). Due to widespread use of these abbreviations, electronic literature searches that use these two search terms may not yield identical results. Thus, the International Society for Clinical Densitometry (ISCD) believes that designating VFA as a term that is manufacturer and software independent will enhance standardization in use and interpretation of this technology. The ISCD proposes using the term VFA to denote densitometric spine imaging regardless of the type of energy (dual or single) or the densitometer/software used. It is important to recognize that the purpose of VFA is to detect vertebral fractures, in contrast to a spine radiograph, which is expected to detect other bone and even soft tissue abnormalities. Thus, although a radiograph may be used for assessing vertebral fractures, it is not limited to that task. We anticipate that radiographic examinations will continue to be termed “spinal radiographs” or “spinal x-rays,” while the acronym VFA will be used specifically for densitometric imaging of the spine. The term VFA has been accepted by two bone densitometer manufacturers (GE Healthcare and Hologic), the American Medical Association (AMA), and the Center for Medicare and Medicaid Services (CMS) (39).
This position is based on expert opinion since literature on this topic does not exist. It is likely to be applicable to all English speaking countries.
II. Indications for VFA
ISCD Official Position
Rationale
Because VFA is a simple, fast, low radiation method for imaging the spine, it could theoretically be performed in all patients who present for central BMD measurement. However, as with any test used in clinical medicine, it should only be offered to patients whose care is likely to be influenced by the results. As such, in developing indications for VFA, the ISCD aimed to identify populations that are at high risk for vertebral fractures. Insights to identify such individuals are available from several large population studies that have identified risk factors for prevalent and/or incident vertebral fractures diagnosed either clinically or radiographically 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50. As there are no large studies evaluating risk factors for fractures detected on VFA, risk factors derived from radiographic studies were used to formulate indications for VFA testing. It was decided that in order for the risk factor to be considered as an indication for VFA testing, it must be supported by large population studies and be relatively easy to identify by a simple questionnaire, such as those commonly used in densitometry centers.
Discussion
Examples of clinical situations in which VFA is appropriate include:
Example 1. Documented height loss of >2 cm (0.75 in) or historical height loss of >4 cm (1.5 in) since young adult.
While some height loss is commonly seen with aging, height loss (defined here as measured current height minus recalled young-adult height), exceeding 4 cm, is two to three times more likely to occur in subjects with vertebral deformities than in those without, with progressively greater height loss occurring in individuals with greater numbers of vertebral deformities 41, 42, 43, 44, 50. Specifically, the Study of Osteoporotic Fractures (42) found an odds ratio (OR) of 2.8 (2.2-3.6) for vertebral fracture in adults with height loss >4 cm. Similar results, an OR equal to 2.9 (2.6-3.3), were observed in the Fracture Intervention Trial (50). Although prevalent vertebral fractures were associated with a smaller magnitude of height loss (3 cm) in men (42), it is practical to use the same figure in both sexes. Measured height loss is useful for detection of incident vertebral fractures. Thus, during 3 years of observation in the VERT trial, a 2 cm height loss was associated with 35% sensitivity and 94% specificity in detecting incident vertebral fractures (47).
Example 2. History of fracture after age 50.
A history of prior fractures is clearly associated with an increased risk of vertebral and non-vertebral fractures 44, 46, 48, 50, 51, 52. Specifically, the relative risk of having vertebral fractures is about 1.5–2 times greater in people who have sustained a prior peripheral fracture than in those who have not. Different studies have reported the association of vertebral fractures with non-vertebral fractures that occurred after age 45, after age 50, or in adulthood in general (51). Thus, the decision to use fractures after age 50 as the indication is arbitrary, but consistent with that used in large observational studies 46, 48. The strength of the association between vertebral fractures and self-reported history of peripheral fracture is similar across different studies with an OR of 1.4 (1.3–1.6) in the Fracture Intervention Trial (51), and 1.5 (1.1–2.3) in the Study of Osteoporotic Fractures (47). Similarly, a relative risk (RR) equal to 1.8 (1.5–2.3) in women, and 1.4 (1.1–1.8) in men was observed in the EPOS study (45), and a RR equal to 2.0 (1.6–2.4) reported in the literature summary by Klotzbuecher (51).
Example 3. Commitment to long-term oral or parenteral glucocorticoid therapy.
Glucocorticoids adversely affect bone metabolism, leading to bone loss and increased fracture risk (53). The increased fracture risk has been observed in patients receiving glucocorticoids for rheumatologic 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67 and pulmonary disease 68, 69, 70, 71, 72, 73. A recent meta-analysis of 7 cohort studies by Kanis et al, which included 42,000 patients, found that any use of glucocorticoids (not stratified by underlying disease) was associated with a relative risk for osteoporotic fracture of 2.2 in men and 1.42 in women (74). Although it is at times difficult to separate the effect of the disease from the effect of steroid therapy, most studies reveal that a glucocorticoid effect is significant even when controlling for disease activity 59, 75, 76.
Evaluation of vertebral fracture status in glucocorticoid-treated patients is justified because a significant proportion (15–53%) of patients treated with these agents sustain osteoporotic fractures 63, 77, 78, 79. For example, incident fractures in the placebo arm of pharmaceutical trials involving glucocorticoid therapy are common and occur rapidly. Incidence rates of 6.8% at 2 years (80), 16.1% in 1 year (77), and 22% over 2 years (81) have been reported.
Many of the studies evaluating the association between glucocorticoid therapy and fractures examined either all osteoporotic fractures or just clinical fractures; however, as vertebral fractures are often not recognized 8, 11, the number of vertebral fractures is likely to be underestimated. Nevertheless, there are several studies that examined the association of glucocorticoid therapy and radiographic vertebral fractures. Some studies used disease-matched controls, while the others used age and sex matched healthy controls. Only 2 studies failed to show differences in fracture rates between glucocorticoid-treated patients and controls 57, 82, while five studies showed a significant correlation between glucocorticoid dose and fracture rates 56, 70, 73, 79, 83. Importantly, many studies included subjects receiving
≤
7.5 mg of prednisone, indicating that even low dose glucocorticoid therapy is associated with vertebral fractures. While some studies evaluated patients treated for over 6 months, others included patients with treatment durations as low as 1 month 56, 57, 3 months (84), or any current use 54, 79, 85. Based on these studies, the ISCD recommends that VFA be performed when a commitment to long-term glucocorticoid therapy is made.
Example 4. History and/or findings suggestive of vertebral fracture not documented by prior radiologic study.
Prior vertebral fractures are a very strong risk factor for subsequent incident vertebral fractures 40, 44, 50, 51, 52. Performing VFA in patients with this history is important, not only to document the number and severity of prevalent fractures, as these are known to influence the risk of future fractures, but also because they need to be taken into account when making therapeutic decisions 9, 86. In addition, VFA may be helpful in detecting new fractures that may have occurred since the last imaging was performed, if the latter was performed in distant past. Examples of clinical information suggestive of vertebral fractures would be a patient's report of new back pain consistent with vertebral fractures, or finding of kyphosis on physical examination.
Note: Although implied in the above discussion, it should be stressed that VFA should not be performed if the results are not likely to alter clinical management, such as in:
These recommendations are supported by large population-based, cross-sectional and observational studies that examined the relationship between risk factors and vertebral fractures detected on radiographs. These risk factors (which included age over 65, height loss of >4 cm, history of peripheral fractures, history of steroid use, and BMD T-score ≤−2.5) have been examined prospectively and recently reported (in abstract form) to be predicative of prevalent vertebral fractures in participants of the OPUS study, which used radiographs (87), and in a small population of densitometry patients (88).
There is good supporting evidence for these recommendations in Caucasian populations. The same recommendations are likely to be applicable to Asian populations, particularly Japanese and Chinese 7, 89, 90, 91, 92.
VFA is just one component of an overall patient management approach. It should be done when the results are likely to influence management, rather than as a population-screening tool. These recommendations are not intended to cover all possible patient situations; clinicians must tailor their clinical decisions to each individual patient. Examples of such situations include obtaining VFA in an older woman with a T-score above −2.0, but no other risk factors, in whom finding a vertebral fracture would prompt therapy. Similarly, VFA might be useful in a patient with osteoporosis, as determined by BMD criteria, if finding a fracture would influence the type of therapeutic agent selected.
VFA is not recommended as a routine screening procedure in patients over a designated age. Although advanced age is a robust predictor of vertebral fracture risk, it is anticipated that age will be considered in the methodology being developed by the World Health Organization (WHO) for prediction of absolute fracture risk, and will therefore be taken into consideration in determining the need for pharmacological intervention. The important impact of advancing age on fracture risk is exemplified by the increase in relative risk for vertebral fracture of approximately 1.5–2.0 for every 10 years increase in age. In population-based studies there is a progressive increase in relative risk for vertebral fracture associated with age over 50 years, and even more so with age over 65 years in Caucasian 1, 2, 3, 4, 6 and Asian (i.e., Japanese and Chinese) populations 7, 89, 90, 91, 92. To our knowledge, there are no data on age-related vertebral fracture prevalence in other racial or ethnic groups.
Vertebral fracture prevalence is similar in men and women aged between 50 and 60 years, presumably because at least some of the fractures in men result from trauma at younger ages (4). However, in older adults both prevalent and incident vertebral fractures are more common in women 1, 2, 3, 4, 6, 45, 52. In EVOS, men at age 75 yr have a vertebral fracture prevalence comparable to that in women over age 65 yr using Eastell's criteria for fracture definition, and around 70 years using McKloskey's criteria 93, 94. Age in males corresponding to fracture incidence at age 65 years in women is around 75 years in EPOS (40) and in the Rotterdam study (52). Given the consistent increase in vertebral fracture risk with advancing age, it seems plausible that age alone, perhaps age 65 yr in women and 70 yr in men, may at some time be considered an indication for performance of VFA. However, such a recommendation is premature at this time and necessitates future research with evaluation of cost-effectiveness.
IV. Method for Defining and Reporting Fractures on VFA
ISCD Official Position
Rationale & Discussion
The method used for diagnosing vertebral fractures remains an ongoing subject of debate, even for interpreting radiographs. Large population studies have used morphometric approaches with different ways of defining vertebral fractures 3, 95, 96, 97, 98. However, morphometric methods have drawbacks when being considered for use in VFA. Specifically, they are cumbersome to apply indiscriminately to all vertebrae in routine clinical practice. Additionally, and importantly, purely morphometric diagnosis is associated with both false positive and false negative results. False positive identification of fractures occurs when the loss of vertebral height is due to non-fracture deformity, while false negative reporting results from failure to diagnose a fractured vertebral body that has a clear depression of the endplate, or that does not meet preset morphometric criteria for fracture 99, 100, 101. Consequently, some combination of visual inspection and quantification of vertebral heights is better suited for clinical diagnosis using VFA. Genant's semiquantitative method (SQ) addresses these concerns by suggesting that each vertebra be visually evaluated, and those that appear abnormal be compared to a chart to determine the grade and type of fracture (102). This method is easy to use in clinical practice, and compares well to more complicated morphometric methods 30, 35, 96. Furthermore, with the exception of earlier clinical trials which used a morphometric approach (103), most recent trials documenting fracture reduction with pharmacologic therapy used a combination of Genant's SQ approach with confirmation of fracture by morphometry 104, 105, 106, 107, 108, 109, 110, 111. Moreover, the visual SQ method was used for fracture diagnosis in the existing publications that have compared fracture detection by VFA and by radiographs 18, 19, 26, 28. Finally, the SQ system is included in the software for both GE Healthcare Lunar and Hologic densitometers. Although any consistent methodology that combines visual and quantitative or semiquantitative aspects would be suitable, using Genant's SQ method has the practical advantages of being included in the current densitometry systems, and being widely used in clinical studies of osteoporosis.
The grade of vertebral deformation should be considered in reporting a ‘fracture’ on VFA. When Genant's SQ approach is used, caution should be exercised when diagnosing Grade 1 deformities as fractures, particularly when such deformities are observed in the thoracic spine. Such a conservative approach is appropriate, as Grade 1 fractures are less predicative of future fractures (86), and are more difficult to detect on VFA (28). Therefore, Grade 2 and 3 deformities should be considered as clear fractures, and Grade 1 reported only if the interpreter is certain that the vertebra is fractured. Considering that many VFA interpreters are likely to be non-radiologists, the committee recommends a 3-step process combining visual, SQ and, if needed, morphometry, when diagnosing fractures on VFA. The recommended steps are to:
There are no studies to address this question, yet the recommendations offered here are likely to be applicable worldwide.
V. Indications for Following VFA with Another Imaging Modality
ISCD Official Position
Note: VFA is designed to detect vertebral fractures and not other abnormalities.
Grade: Poor-C-1
Rationale & Discussion
Since there are no studies that examine when VFA should be followed by another imaging modality, the recommendations given in the introduction are based on expert opinion. It is important to consider the overall clinical care of the patient in making the decision for further testing. The instances below are examples of possible situations where additional imaging may be useful:
VI. Components of a VFA Report
ISCD Official Position
Rationale
An appropriate VFA report should include information that identifies the patient, assists the interpreter in evaluating the scan, conveys the validity of the study, and provides clear scan interpretation and recommendations where appropriate.
The position stated is based on expert opinion and a previous publication stating the appropriate components of a BMD report (112). The conclusions are applicable worldwide.
In Summary
The ISCD Official Positions on VFA represent an effort to create order in the use of a newly developed technology that has important clinical implications. It is likely that these positions will evolve over time as new data become available. Further research, designed to address issues that may emerge through the course of clinical use, should be undertaken to expand the body of knowledge and move the field of clinical densitometry forward.
Acknowledgments
The following served as advisors/consultants during the VFA subcommittees work in developing these Official Positions:
Richard Eastell, M.D., FRCP, FRCPath, FMedSci, University of Sheffield Clinical Sciences Ctr, Sheffield, S Yorkshire, UK.
Harry Genant, M.D., Ph.D., University Of California, San Francisco, CA, USA.
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PII: S1094-6950(06)00188-0
doi:10.1016/j.jocd.2006.05.006
© 2006 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.
