When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
PRACTICE GUIDELINES AND POSITION STATEMENTS
AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS
The ACOG (2012, reaffirmed 2016) updated its guidelines on managing osteoporosis in women. The guidelines recommended that BMD screening should begin for all women at age 65 years. In addition, the ACOG recommended screening for women younger than 65 years in whom the Fracture Risk Assessment Tool indicates a 10-year risk of osteoporotic fracture of at least 9.3. Alternatively, ACOG recommended BMD screening women younger than 65 or with any of the following risk factors (they are similar, but not identical to risk factors in the Fracture Risk Assessment Tool):
NATIONAL OSTEOPOROSIS FOUNDATION
The NOF (2014) updated its practice guidelines. The NOF guidelines recommended that all postmenopausal women and men ages 50 and older be evaluated clinically for osteoporosis risk to determine the need for BMD testing.
Indications for BMD testing included:
The NOF also indicated that:
“Central DXA [dual x-ray absorptiometry] assessment of the hip or lumbar spine is the ‘gold standard’ for serial assessment of BMD. Biological changes in bone density are small compared to the inherent error in the test itself, and interpretation of serial bone density studies depends on appreciation of the smallest change in BMD that is beyond the range of error of the test. This least significant change (LSC) varies with the specific instrument used, patient population being assessed, measurement site, technologist’s skill with patient positioning and test analysis, and the confidence intervals used. Changes in the BMD of less than 3-6 % at the hip and 2-4 % at the spine from test to test may be due to the precision error of the testing itself.”
AMERICAN COLLEGE OF PHYSICIANS
The guidelines from the American College of Physicians (2017) on the treatment of osteoporosis recommended against bone density monitoring during the 5-year pharmacologic treatment period of osteoporosis in women (weak recommendation, low-quality evidence). The American College of Physicians noted that data from several studies showed a reduction in fractures with pharmacologic treatment, even when BMD did not increase. In addition, current evidence “does not support frequent monitoring of women with normal bone density for osteoporosis, because data showed that most women with normal CSA scores did not progress to osteoporosis with 15 years.”
AMERICAN COLLEGE OF RADIOLOGY
Appropriateness criteria from the American College of Radiology, updated in 2017, state that BMD measurement is indicated whenever a clinical decision is likely to be directly influenced by the result of the test. Indications for DXA of the lumbar spine and hip included but were not limited to the following patient populations:
1. All women age 65 years and older and men age 70 years and older (asymptomatic screening)
2. Women younger than age 65 years who have additional risk for osteoporosis, based on medical history and other findings. Additional risk factors for osteoporosis include:
b. A history of maternal hip fracture that occurred after the age of 50 years
c. Low body mass (less than 127 lb or 57.6 kg)
d. History of amenorrhea (more than 1 year before age 42 years)
b. Loss of height, thoracic kyphosis
5. Individuals age 50 years and older who develop a wrist, hip, spine, or proximal humerus fracture with minimal or no trauma, excluding pathologic fractures
6. Individuals of any age who develop one or more insufficiency fractures
7. Individuals being considered for pharmacologic therapy for osteoporosis.
8. Individuals being monitored to:
b. Follow-up medical conditions associated with abnormal BMD.
INTERNATIONAL SOCIETY FOR CLINICAL DENSITOMETRY
The 2013 update of theInternational Society for Clinical Densitometry guidelines recommended bone density testing in the following patients:
AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY
The American Association of Clinical Endocrinologists and American College of Endocrinology (2016) issued updated joint guidelines on the diagnosis and treatment of postmenopausal osteoporosis. The guidelines listed the potential uses for BMD measurements in postmenopausal women as:
US PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
The USPSTF (2018) updated its recommendations on screening for osteoporosis with bone density measurements. The USPSTF recommended screening for osteoporosis in women aged 65 years or older and in postmenopausal women younger than 65 years at increased risk of osteoporosis. The supporting document notes there are multiple instruments to predict risk for low BMD, including the Fracture Risk Assessment Tool. The updated USPSTF recommendations stated that the scientific evidence is “insufficient” to assess the balance of benefits and harms of screening for osteoporosis screening in men. The Task Force did not recommend specific screening tests but said the most commonly used tests are DXA of the hip and lumbar spine and quantitative ultrasound of the calcaneus.
The USPSTF concluded the evidence base is sparse on screening interval. While two studies showed no advantage to repeated testing, other evidence suggested that the optimal screening interval may vary by baseline BMD, age, and use of hormone replacement therapy.
CLINICAL PRACTICE GUIDELINES FOR THE CARE OF GIRLS AND WOMEN WITH TURNER SYNDROME
The Clinical Practice Guidelines for the Care of Girls and Women with Turner Syndrome (Gravholt, et al., 2017) recommends a DEXA scan every 5 years due to the increased risk of osteoporosis in these patients.
FINITE ELEMENT ANALYSIS
Quantitative computed tomography-based finite element analysis (QCT/FEA) estimates fracture strength using 3D bone mineral distribution and geometry. The finite element analysis (FEA) is a computer simulation method, which is being investigated as a tool for bone fragility prediction. FEA considers both, the individual geometric and densitometric parameters retrieved from computed tomography imaging. In homogenized continuum level voxel based FE (hvFE) models, voxels are directly converted to hexahedral elements with specific homogenized material properties depending on local bone density. An example of a FEA test is the VirtuOst test. FEA ) is the central technology used in the proprietary VirtuOst test to conduct a "virtual" stress test for determining breaking strength. This virtual stress test considers the amount of bone mass a patient has, as well as bone size, shape, and internal structure, and provides analysis called Biomechanical Computer Tomography Analysis (BCT), CT-based measurements for BMD and bone strength.
Johannesdottir and associates (2018) reviewed the ability of CT-based methods (e.g., finite element analysis [FEA]) to predict incident hip and vertebral fractures. These investigators stated that CT-based techniques with concurrent calibration all showed strong associations with incident hip and vertebral fracture, predicting hip and vertebral fractures as well as, and sometimes better than, dual-energy X-ray absorptiometry areal biomass density (DXA aBMD). There is growing evidence for use of routine CT scans for bone health assessment. These investigators noted that CT-based techniques provide a robust approach for osteoporosis diagnosis and fracture prediction. It remains to be seen if further technical advances will improve fracture prediction compared to DXA aBMD. Future work should include more standardization in CT analyses, establishment of treatment intervention thresholds, and more studies to determine whether routine CT scans can be efficiently used to expand the number of individuals who undergo evaluation for fracture risk.
Groenen and colleagues (2018) noted that current FE models predicting failure behavior comprise single vertebrae, thereby neglecting the role of the posterior elements and intervertebral discs. These investigators developed a more clinically relevant, case-specific non-linear FE model of 2 functional spinal units able to predict failure behavior in terms of the vertebra predicted to fail; deformation of the specimens; stiffness; and load to failure. In addition, they examined the effect of different bone density-mechanical properties relationships (material models) on the prediction of failure behavior. Twelve 2 functional spinal units (T6 to T8, T9 to T11, T12 to L2, and L3 to L5) with and without artificial metastases were destructively tested in axial compression. These experiments were simulated using CT-based case-specific non-linear FE models. Bone mechanical properties were assigned using 4 commonly used material models. In 10 of the 11 specimens, the FE model was able to correctly indicate which vertebrae failed during the experiments. However, predictions of the three-dimensional (3D) deformations of the specimens were less promising. Whereas stiffness of the whole construct could be strongly predicted (R2 = 0.637 to 0.688, p < 0.01), these researchers obtained weak correlations between FE predicted and experimentally determined load to failure, as defined by the total reaction force exhibiting a drop in force (R2 = 0.219 to 0.247, p > 0.05). Furthermore, they found that the correlation between predicted and experimental fracture loads did not strongly depend on the material model implemented, but the stiffness predictions did. The authors concluded that whereas the FE model was able to correctly indicate which vertebrae failed during the experiments, it had difficulties predicting the 3D deformation of the specimens. In addition, stiffness could be strongly predicted by this model, but these researchers obtained weak correlations between FE predicted and experimentally determined vertebral strength. Thus, this work showed that, in its current state, the FE models may be used to identify the weakest vertebra, but that substantial improvements are needed to quantify in-vivo failure loads.
These investigators stated that the FE model might profit from more realistic intervertebral discs (IVDs) models. In contrast to the bone material behavior, the IVD properties used in this study were not case-specific but obtained from the literature. However, both the type of material model and values for coefficients used in previous FE studies varied highly. The effect of these varying parameters on predictions of vertebral stiffness and/or bone strength is not well-studied. Thus, effort could be put in determining (case‐specific) mechanical properties of IVD tissue, and, subsequently, in examining how implementing these properties in FE models affects the failure behavior of both single vertebra and 2 functional spinal units. In addition, gaining more insight into the effect of IVD properties on endplate failure would be valuable, as endplate failure could not be captured correctly by the current FE model. For this reason, emphasis should also be put on further characterizing and adequately simulating the endplates’ mechanical properties. Furthermore, in case of sufficient resources and anatomical specimens, it would be interesting to combine testing of 2 functional spinal units with single vertebra tests; thus, the validity of the material models could be better tested. These researchers also stated that whereas in the experiments soft tissues, including the spinal ligaments and facet capsules, were left intact, these structures were not accounted for in the FE simulations. Spinal ligaments may contribute to the specimens’ stiffness and strength, especially when moving in flexion, extension, or lateral bending. As these researchers allowed the specimens to pivot around the load application point, such movements could occur. Adding ligaments and facet capsules to the FE model provides loading conditions being more realistic and better mimicking the experimental conditions, which potentially results in a better predictive capacity of the FE model.
Rajapakse and Chang (2018) noted that hip fractures have catastrophic consequences. These investigators reviewed recent developments in high-resolution magnetic resonance imaging (MRI)-guided FEA of the hip as a means to determine subject-specific bone strength. Despite the ability of DXA to predict hip fracture, the majority of fractures occur in patients who do not have BMD T scores less than - 2.5. Thus, without other detection methods, these individuals go undetected and untreated. Of methods available to image the hip, MRI is currently the only one capable of depicting bone microstructure in-vivo. Availability of micro-structural MRI allowed generation of patient-specific micro-FE models that can be used to simulate real-life loading conditions and determine bone strength. The authors concluded that MRI-based FEA enabled radiation-free approach to evaluate hip fracture strength. These researchers stated that with further validation, this technique could become a potential clinical tool in managing hip fracture risk.
Allaire and co-workers (2019) stated that previous studies showed vertebral strength from CT-based FEA may be associated with vertebral fracture risk. These investigators found vertebral strength had a strong association with new vertebral fractures, suggesting that vertebral strength measures may identify those at risk for vertebral fracture and may be a useful clinical tool. In a case-control study, these researchers examined the association between vertebral strength by QCT-based FEA and incident vertebral fracture (VF). In addition, they determined sensitivity and specificity of previously proposed diagnostic thresholds for fragile bone strength and low BMD in predicting VF. A total of 26 incident VF cases (13 men, 13 women) and 62 age- and sex-matched controls aged 50 to 85 years were selected from the Framingham multi-detector CT cohort. Vertebral compressive strength, integral volumetric BMD (vBMD), trabecular vBMD, CT-based BMC, and CT-based aBMD were measured from CT scans of the lumbar spine. Lower vertebral strength at baseline was associated with an increased risk of new or worsening VF after adjusting for age, BMI, and prevalent VF status (OR = 5.2 per 1 SD decrease, 95 % CI: 1.3 to 19.8). Area under receiver operating characteristic (ROC) curve comparisons revealed that vertebral strength better predicted incident VF than CT-based aBMD (AUC = 0.804 versus 0.715, p = 0.05); but was not better than integral vBMD (AUC = 0.815) or CT-based BMC (AUC = 0.794). Furthermore, proposed fragile bone strength thresholds trended toward better sensitivity for identifying VF than that of aBMD-classified osteoporosis (0.46 versus 0.23, p = 0.09). The authors concluded that the findings of this study showed an association between vertebral strength measures and incident vertebral fracture in men and women. These researchers stated that although limited by a small sample size (n = 26), these findings also suggested that bone strength estimates by CT-based FEA provided equivalent or better ability to predict incident vertebral fracture compared to CT-based aBMD. These findings need to be validated by well-designed studies.
Westbury and colleagues (2019) noted that high-resolution peripheral QCT (HRpQCT) is increasingly used for examining associations between bone micro-architectural and FEA parameters and fracture. These researchers hypothesized that combining bone micro-architectural parameters, geometry, BMD and FEA estimates of bone strength from HRpQCT may improve discrimination of fragility fractures. The analysis sample comprised of 359 subjects (aged 72 to 81 years) from the Hertfordshire Cohort Study (HCS). Fracture history was determined by self-report and vertebral fracture assessment. Subjects underwent HRpQCT scans of the distal radius and DXA scans of the proximal femur and lateral spine. Poisson regression with robust variance estimation was used to derive relative risks (RRs) for the relationship between individual bone micro-architectural and FEA parameters and previous fracture. Cluster analysis of these parameters was then performed to identify phenotypes associated with fracture prevalence. Receiver operating characteristic analysis suggested that bone micro-architectural parameters improved fracture discrimination compared to areal BMD (aBMD) alone, whereas further inclusion of FEA parameters resulted in minimal improvements. Cluster analysis (k-means) identified 4 clusters. The 1st had lower Young modulus, cortical thickness, cortical volumetric density and Von Mises stresses compared to the wider sample; fracture rates were only significantly greater among women (RR [95 % CI] compared to lowest risk cluster: 2.55 [1.28 to 5.07], p = 0.008). The 2nd cluster in women had greater trabecular separation, lower trabecular volumetric density and lower trabecular load with an increase in fracture rate compared to lowest risk cluster (1.93 [0.98 to 3.78], p = 0.057). These findings may help inform intervention strategies for the prevention and management of osteoporosis. The authors concluded that micro-architectural deterioration, bone geometry and, in women, FEA-derived bone strength contributed to an increased risk of previous fracture. Cluster analysis revealed a cortical and a trabecular deficiency phenotype, which both showed lower aBMD in men and women. Only women with the cortical deficiency phenotype had significantly increased risk of previous fractures. In this cohort, adding bone micro-architectural parameters to aBMD could better predict previous fracture, but further addition of FEA conferred little benefit.
The authors stated that this study had several drawbacks. First, a healthy responder bias has been observed in HCS and examining subject characteristics according to inclusion status has revealed healthier lifestyles at baseline for subjects included in the analysis sample compared to those who were not. However, these analyses were internal, so bias would only arise if the associations of Interest differed systematically between those who were included in the analysis sample and those who were not; this appeared unlikely. Second, temporal causation could not be inferred as this study had a cross-sectional design. It may be that the differences in bone microstructure observed were secondary to re-modelling in response to fracture, rather than properties of the bone that predispose to fracture, especially as these researchers had only collected information regarding previous fractures. Third, fracture status was missing for some subjects, although this information was available for the vast majority (91.9 %) of the analysis sample. Fourth, the low numbers of reported fractures and a relatively small sample size, along with the lack of stability regarding cluster analysis algorithms in general, may limit the generalizability of findings. However, the similarity of the clusters observed to those in other analyses and their biological plausibility suggested that they were robust.
In a review by Lewiecki, 2019 on “Osteoporotic fracture risk assessment,” the author lists FEA as one of the new and emerging technologies. The review states that “Finite element analysis (FEA) uses computer models of images and data from QCT of the spine or hip to assess bone strength. QCT-based FEA can be used to predict vertebral fracture in postmenopausal women and is comparable with spine DXA in predicting vertebral fractures in men; it is also comparable with hip DXA in predicting hip fractures in postmenopausal women and older men. FEA cannot be used to diagnose osteoporosis, initiate therapy, or monitor therapy. While all of these technologies have provided insight into skeletal properties other than BMD that determine bone strength, their role in clinical practice has not been defined. These techniques are used primarily in research settings”.
Bone mineral density (BMD) studies can be used to identify individuals with osteoporosis and monitor response to osteoporosis treatment, with the goal of reducing the risk of fracture. Bone density is most commonly evaluated with dual x-ray absorptiometry (DXA); other technologies are available.
For individuals who are eligible for screening of BMD based on risk factor assessment who receive DXA analysis of central sites (hip or spine), the evidence includes systematic reviews of randomized controlled trials and cohort studies. The relevant outcomes are morbid events, functional outcomes, quality of life, hospitalizations, and medication use. Central DXA is the most widely accepted method for measuring BMD and is the reference standard against which other screening tests are evaluated. BMD measurements with central DXA identify individuals at increased risk of fracture, and osteoporosis medications reduce fracture risk in the population identified as osteoporotic by central DXA. Therefore, test results with initial central DXA can be used to guide therapy.
For individuals without osteoporosis on initial screen who receive repeat DXA analysis of central sites (hip or spine), the evidence includes systematic reviews of large cohort and observational studies. The relevant outcomes are morbid events, functional outcomes, quality of life, hospitalizations, and medication use. Little research has been done on the frequency of BMD monitoring for osteoporosis. The available research has evaluated repeat measurement with central DXA. Evidence on whether repeat measurements add to risk prediction compared with a single measurement is mixed. Although the optimal interval may differ depending on risk factors, current evidence does not support repeat monitoring in patients with BMD on DXA in the normal range.
For individuals who are receiving pharmacologic treatment for osteoporosis who receive repeat DXA analysis of central sites (hip or spine), the evidence includes systematic reviews of randomized controlled trials and observational studies. The relevant outcomes are morbid events, functional outcomes, quality of life, hospitalizations, and medication use. There is no high-quality evidence to guide how often to monitor BMD during osteoporosis treatment. Within-person variation in measurement may exceed treatment effects, and fracture risk has been shown to be reduced in some treatment studies in the absence of changes in BMD. Together, these results suggest that frequent (i.e., every two years) repeat monitoring has low value. It is unclear whether DXA at the end of the initial five years of therapy is sufficiently accurate to guide subsequent therapy.
For individuals who are eligible for screening of BMD based on risk factor assessment who receive ultrasound densitometry, or quantitative computed tomography (including CT-based methods such as finite element analysis [FEA]), or DXA analysis of peripheral sites, the evidence includes observational studies and systematic reviews. The relevant outcomes are morbid events, functional outcomes, quality of life, hospitalizations, and medication use. In comparison with central DXA, other measures of bone health showed area under the curves around 0.80 for the identification of osteoporosis. These technologies are not commonly used for BMD measurements in practice, and no studies have shown that they can select patients who benefit from treatment for osteoporosis. There is little to no evidence on the usefulness of repeat measurement of BMD using these techniques.
ACR Appropriateness Criteria™. Osteoporosis and bone mineral density. 2016 Available online at: https://acsearch.acr.org/docs/69358/Narrative/. Accessed June 29, 2018.
Adams AL, Fischer H, Kopperdahl DL, et al. Osteoporosis and Hip Fracture Risk From Routine Computed Tomography Scans: The Fracture, Osteoporosis, and CT Utilization Study (FOCUS). J Bone Miner Res. Jul 2018;33(7):1291-1301. PMID 29665068
Adler RA, El-Hajj Fuleihan G, Bauer DC, et al. Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research.. J. Bone Miner. Res., 2016 Oct 21;31(10). PMID 27759931
Agency for Healthcare Research and Quality. Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: Update of a 2007 Report. 2012; https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoporosis-bone-fracture_research.pdf. Accessed January 2, 2020.
Allaire BT, Lu D, Johannesdottir F, et al. Prediction of incident vertebral fracture using CT-based finite element analysis. Osteoporos Int. 2019 30(2):323-331.
American Academy of Orthopaedic Surgeons (AAOS). Osteoporosis tests. [AAOS Web site]. August 2009. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00413. http://orthoinfo.aaos.org/fact/thr_report.cfm?Thread_ID=176&topcategory=Osteoporosis.Accessed June 29, 2018.
American Academy of Pediatrics. Committee on Adolescence. Identifying and treating eating disorders. Pediatrics. 2003; 111(1):204-211.
American Association of Clinical Endocrinologists (AACE) Osteoporosis Task Force. AACE Medical Guidelines for Clinical Practice for the diagnosis and treatment of postmenopausal osteoporosis- 2016. Endocr Pract. 2016; 22(Suppl 4): 1-42. Also available on the AACE Web site at: https://www.aace.com/files/postmenopausal-guidelines.pdf. Accessed July 2, 2018.
American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Osteoporosis (Practice Bulletin N. 129). Obstet Gynecol. 2012; 120(3):718-34.
American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins. Osteoporosis (Practice Bulletin N. 129). Obstet Gynecol. Sep 2012, reaffirmed 2014;120(3):718-734. PMID 22914492
Amiel C, Ostertag A, Slama L, et al. BMD is reduced in HIV-infected men irrespective of treatment. J Bone Miner Res. 2004; 19(3):402-409.
Amin S, Felson DT. Osteoporosis in men. Rheum Dis Clin North Am. 2001; 27(1):19-47.
Aparicio LF, Jurkovic M, DeLullo J. Decreased bone density in ambulatory patients with duchenne muscular dystrophy. J Pediatr Orthop. 2002; 22(2):179-181.
Apkon SD. Osteoporosis in children who have disabilities. Phys Med Rehabil Clin N Am. 2002; 13(4):839-855.
Aris RM, Merkel PA, Bachrach LK, et al. Guide to bone health and disease in cystic fibrosis. J Clin Endocrinol Metab. 2005; 90(3):1888-1896.
Bachman DM, Crewson PE, Lewis RS. Comparison of heel ultrasound and finger DXA to central DXA in the detection of osteoporosis. Implications for patient management. J Clin Densitom. 2002; 5(2):131-141.
Bae DC, Stein BS. The diagnosis and treatment of osteoporosis in men on androgen deprivation therapy for advanced carcinoma of the prostate. J Urol. 2004; 172(6 Pt 1):2137-2144.
Baim S, Leonard MB, Bianchi ML, et al. Official positions of the International Society for Clinical Densitometry and executive summary of the 2007 ISCD Pediatric Position Development Conference. J Clin Densitom. 2008; 11(1):6-21.
Bell KJ, Hayen A, Macaskill P, et al. Value of routine monitoring of bone mineral density after starting bisphosphonate treatment: secondary analysis of trial data. BMJ. 2009; 338:b2266.
Berger C, Langsetmo L, Joseph L, et al. Canadian Multicentre Osteoporosis Study Research Group. Change in bone mineral density as a function of age in women and men and association with the use of antiresorptive agents. CMAJ. 2008; 178(13):1660-8.
Berry SD, Samelson EJ, Pencina MJ et al. Repeat bone mineral density screening and prediction of hip and major osteoporotic fracture. JAMA. 2013; 310(12):1256-62.
Binkley N, Krueger D. Osteoporosis in men. WMJ. 2002; 101(4):28-32.
Black DM, Bilezikian JP, Ensrud KE, et al, and the PaTH Study Investigators. One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. N Engl J Med. 2005; 353(6):555-565.
Blake GM, Fogelman I. Applications of bone densitometry for osteoporosis. Endocrinol Metab Clin North Am. 1998; 27(2):267-288.
Blake GM, Fogelman I. Monitoring treatment for osteoporosis by using bone densitometry. Semin Nucl Med. 2001; 31(3):212-222.
Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Ultrasonography of the heel for diagnosing osteoporosis and selecting patients for pharmacologic treatment. TEC Assessments. 1999;Volume 14:Tab 19.
Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Ultrasonography of peripheral sites for diagnosing and selecting patients for pharmacologic treatment for osteoporosis. TEC Assessments. 2002;Volume 17:Tab 5.
Blue Cross and Blue Shield Association, Technology Evaluation Center (TEC). Monitoring of bone density to assess active treatment of osteoporosis. TEC Assessments 1999; Volume 14, Tab 24.
Blue Cross and Blue Shield Association, Technology Evaluation Center (TEC). Ultrasonography of the heel for diagnosing osteoporosis and selecting patients for pharmacologic treatment. TEC Assessments 1999; Volume 14, Tab 19.
Brunader R, Shelton DK. Radiologic bone assessment in the evaluation of osteoporosis. Am Fam Physician. 2002; 65(7):1357-1364.
Burgess E, Nanes MS. Osteoporosis in men: pathophysiology, evaluation, and therapy. Curr Opin Rheumatol. 2002; 14(4):421-428.
Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis - 2016. Endocr Pract. Sep 02 2016;22(Suppl 4):1-42. PMID 27662240
Carrasco F, Ruz M, Rojas P, et al. Changes in bone mineral density, body composition and adiponectin levels in morbidly obese patients after bariatric surgery. Obes Surg. 2009; 19(1):41-6.
Castro J, Toro J, laZaro L, et al. Bone mineral density in male adolescents with anorexia nervosa. J Am Acad Child Adolesc Psychiatry. 2002; 41(5):613-618.
Centers for Medicare & Medicaid Services (CMS). National Coverage Determination for Bone (Mineral) Density Studies (150.3). 2007; http://www.cms.gov/Regulations-and- Guidance/Guidance/Transmittals/downloads/R70BP.pdf. Accessed January 2, 2020.
Crandall CJ, Newberry SJ, Diamant A, et al. Comparative effectiveness of pharmacologic treatments to prevent fractures: an updated systematic review. Ann Intern Med. Nov 18 2014;161(10):711-723. PMID 25199883
Cummings SR, Nevitt MC, Browner WS, et al. Risk factors for hip fracture in white women. Study of Osteoporotic Fractures Research Group. N Engl J Med. 1995; 332(12):767-773.
Cummings SR, Palermo L, Browner W, et al. Monitoring osteoporosis therapy with bone densitometry: misleading changes and regression to the mean. Fracture Intervention Trial Research Group. JAMA. 2000; 283(10):1318-21.
Deal CL. Using bone densitometry to monitor therapy in treating osteoporosis: pros and cons. Curr Rheumatol Rep. 2001; 3(3):233-239.
Dolan SE, Huang JS, Killilea KM, et al. Reduced bone density in HIV-infected women. AIDS. 2004; 18(3):475-483.
Eastell R, Boyle IT, Compston J, et al. Management of male osteoporosis: report of the UK Consensus Group. QJM. 1998; 91(2):71-92.
Eastell R, Rosen CJ, Black DM, et al. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society* Clinical Practice Guideline.. J. Clin. Endocrinol. Metab., 2019 Mar 26;104(5). PMID 30907953
Eastell R. Treatment of postmenopausal osteoporosis. N Engl J Med. 1998; 338(11):736-746.
Ekman A, Michaëlsson K, Petrén-Mallmin M, et al. DXA of the hip and heel ultrasound but not densitometry of the fingers can discriminate female hip fracture patients from controls: a comparison between four different methods. Osteoporos Int. 2001; 12(3):185-191.
Elffors L. Are osteoporotic fractures due to osteoporosis? Impacts of a frailty pandemic in an aging world. Aging (Milano). 1998; 10(3):191-204.
Expert Panel on Musculoskeletal I, Ward RJ, Roberts CC, et al. ACR Appropriateness Criteria((R)) Osteoporosis and Bone Mineral Density. J Am Coll Radiol. May 2017;14(5S): S189-S202. PMID 28473075
Faulkner KG, McClung MR, Ravn DJ, et al. Monitoring skeletal response to therapy in early post-menopausal women: which bone to measure. J Bone Miner Res. 1996; 11(suppl 1):S96.
Faulkner KG, Orwoll E. Implications in the use of T-scores for the diagnosis of osteoporosis in men. J Clin Densitom. 2002; 5(1):87-93.
Feldstein AC, Nichols G, Orwoll E, et al. The near absence of osteoporosis treatment in older men with fractures. Osteoporos Int. 2005; 16(8):953-62.
Fleischer J, Stein EM, Bessler M, et al. The decline in hip bone density after gastric bypass surgery is associated with extent of weight loss. J Clin Endocrinol Metab. 2008; 93(10):3735-40.
Frost ML, Blake GM, Fogelman I. Changes in QUS and BMD measurements with antiresorptive therapy: a two-year longitudinal study. Calcif Tissue Int. 2001; 69(3):138-146.
Frost SA, Nguyen ND, Center JR, et al. Discordance of longitudinal changes in bone density between densitometers. Bone. 2007; 41(4):690-7.
Frost SA, Nguyen ND, Center JR, et al. Timing of repeat BMD measurements: development of an absolute risk-based prognostic model. J Bone Miner Res. 2009; 24(11):1800-7.
Gadam RK, Schlauch K, Izuora KE. Frax prediction without BMD for assessment of osteoporotic fracture risk. Endocr Pract. 2013; 19(5):780-4.
Gafni RI, Baron J. Overdiagnosis of osteoporosis in children due to misinterpretation of dual-energy x-ray absorptiometry (DEXA). J Pediatr. 2004; 144(2):253-257.
Gourlay ML, Brown SA. Clinical considerations in premenopausal osteoporosis. Arch Intern Med. 2004; 164(6):603-614.
Gourlay ML, Fine JP, Preisser JS et al. Bone-density testing interval and transition to osteoporosis in older women. N Engl J Med. 2012; 366(3):225-33.
Gourlay ML, Fine JP, Preisser JS, et al. Bone-density testing interval and transition to osteoporosis in older women. N Engl J Med. Jan 19 2012;366(3):225-233. PMID 22256806
Gourlay ML, Overman RA, Ensrud KE. Bone Density Screening and Re-screening in Postmenopausal Women and Older Men. Current osteoporosis reports. Dec 2015;13(6):390-398. PMID 26408154
Gourlay ML, Preisser JS, Lui LY et al. BMD screening in older women: initial measurement and testing interval. J Bone Miner Res. 2012; 27(4):743-6.
Green AD, Colón-Emeric CS, Bastian L, Drake MT, Lyles KW. Does this woman have osteoporosis? JAMA. 2004; 292(23):2890-2900.
Greenspan SL, Cheng S, Miller PD, Orwoll ES; QUS-2 PMA Trials Group. Clinical performance of a highly portable, scanning calcaneal ultrasonometer. Osteoporos Int. 2001; 12(5):391-398.
Groenen KHJ, Bitter T, van Veluwen TCG, et al. Case-specific non-linear finite element models to predict failure behavior in two functional spinal units. J Orthop Res. 2018;36(12):3208-3218.
Hans D, Dargent-Molina P, Schott AM. Ultrasonographic heel measurements to predict hip fracture in elderly women: the EPIDOS prospective study. Lancet. 1996; 348(9026):511-514.
Hillier TA, Stone KL, Bauer DC, et al. Evaluating the value of repeat bone mineral density measurement and prediction of fractures in older women: the study of osteoporotic fractures. Arch Intern Med. 2007; 167(2):155-60.
Horlick M, Wang J, Pierson RN Jr, Thornton JC. Prediction models for evaluation of total-body bone mass with dual-energy X-ray absorptiometry among children and adolescents. Pediatrics. 2004; 114(3):e337-345.
http://www.ncbi.nlm.nih.gov/books/NBK45201/pdf/TOC.pdf. Accessed July 5, 2018.
https://cdn.nof.org/wp-content/uploads/2016/01/995.pdf Accessed July 5, 2018.
Institute for Clinical Systems Improvement (ICSI). Diagnosis and treatment of osteoporosis. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2006.
International Society for Clinical Densitometry (ISCD). Official positions 2015. Indications for bone mineral density (BMD) testing. [ISCD Web site]. 2015. Available at: http://www.iscd.org/official-positions/2015-iscd-official-positions-adult/. Accessed July 5, 2018.
International Society for Clinical Densitometry. 2013 ISCD Official Positions-Adult 2013; http://www.iscd.org/official-positions/2013-iscd-official-positions-adult/. Accessed January 2, 2020.
Jacobs-Kosmin D, Hobar C, Shanmugam S. Osteoporosis. [eMedicine Web site]. Updated July 2, 2018. Available at: http://www.emedicine.com/med/topic1693.htm. Accessed July 5, 2018.
Johannesdottir F, Allaire B, Bouxsein ML, et al. Fracture prediction by computed tomography and finite element analysis: Current and future perspectives. Curr Osteoporos Rep. 2018;16(4):411-422.
Johnell O, Kanis JA, Oden A, et al. Predictive value of BMD for hip and other fractures. J Bone Miner Res. 2005; 20(7):1185-94.
Jørgensen HL, Warming L, Bjarnason NH, et al.Andersen PB, Hassager C. How does quantitative ultrasound compare to dual X-ray absorptiometry at various skeletal sites in relation to the WHO diagnosis categories? Clin Physiol. 2001; 21(1):51-59.
Kanis JA. Diagnosis of osteoporosis and assessment of fracture risk. Lancet. 2002; 359(9321):1929-1936.
Karjalainen J, Riekkinen O, Kroger H. Pulse- echo ultrasound method for detection of post-menopausal women with osteoporotic BMD. Osteoporos Int. 2018 .29(5):1193-1199.
Karjalainen J, Riekkinen O, Toyras J, et al. New method for point-of-care osteoporosis screening and diagnostics. Osteoporos Int. 2016. 27:971-977.
Kelepouris N, Harper KD, Gannon F, et al. Severe osteoporosis in men. Ann Intern Med. 1995;23(6):452-460.
Kenny AM, Prestwood KM. Osteoporosis. Pathogenesis, diagnosis, and treatment in older adults. Rheum Dis Clin North Am. 2000; 26(3):569-591.
Koval PG, Easterling L, Pettus D, et al. Clinical inquiries. How should a DEXA scan be used to evaluate bisphosphonate therapy for osteoporosis? J Fam Pract. 2005; 54(1):65-71.
LaCroix AZ, Buist DS, Brenneman SK, Abbott TA 3rd. Evaluation of three population-based strategies for fracture prevention: results of the osteoporosis population-based risk assessment (OPRA) trial. Med Care. 2005; 43(3):293-302.
Lewiecki EM, Compston JE, Miller PD et al. Official positions for FRAX® Bone Mineral Density and FRAX® simplification from Joint Official Positions Development Conference of the International Society for Clinical Densitometry and International Osteoporosis Foundation on FRAX®. J Clin Densitom. 2011; 14(3):226-36.
Lewiecki EM. Osteoporotic fracture risk assessment. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed June 2019.
Mayo Clinic. Bone density test. [Mayo Clinic Web site]. 08/21/2014. Available at: http://www.mayoclinic.com/health/osteoporosis/DS00128/DSECTION=1http://www.mayoclinic.com/health/bone-density-test/MY00304 http://www.mayoclinic.org/tests-procedures/bone-density-test/basics/definition/prc-20020254. Accessed July 5, 2018.
Mayo Clinic. Osteoporosis. [Mayo Clinic Web site]. Revised 07/06/2016. Available at: http://www.mayoclinic.com/health/osteoporosis/DS00128/DSECTION=1. Accessed July 5 ,2018.
McDonagh JE. Osteoporosis in juvenile idiopathic arthritis. Curr Opin Rheumatol. 2001; 13(5):399-404.
Miller PD, Zapalowski C, Kulak CA, Bilezikian JP. Bone densitometry: the best way to detect osteoporosis and to monitor therapy. J Clin Endocrinol Metab. 1999; 84(6):1867-1871.
Moyad MA. Preventing male osteoporosis: prevalence, risks, diagnosis and imaging tests. Urol Clin North Am. 2004; 31(2):321-330.
Mussolino ME, Looker AC, Madans JH, et al. Risk factors for hip fracture in white men: the NHANES I Epidemiologic Follow-up Study. J Bone Miner Res. 1998; 13(6):918-924.
National Institute for Health and Care Excellence (NICE). Bindex for investigating suspected osteoporosis. [NICE website]. May 31, 2017. Available at: https://www.nice.org.uk/advice/mib106. Accessed June 26, 2018.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Juvenile osteoporosis. [NIAMS Web site]. Reviewed June 2015. Available at: http://www.niams.nih.gov/Health_Info/Bone/Bone_Health/Juvenile/juvenile_osteoporosis.asp. Accessed July 5, 2018.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Osteoporosis in men. [NIAMS Web site]. Reviewed June 2015. Available at: http://www.niams.nih.gov/Health_Info/Bone/Osteoporosis/men.asp. Accessed July 5, 2018.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Osteoporosis overview. [NIAMS Web site]. Reviewed June 2015. Available at: https://www.bones.nih.gov/health-info/bone/osteoporosis/overview Accessed July 5, 2018.
National Osteoporosis Foundation. Clinician's guide to prevention and treatment of osteoporosis. 2014; https://my.nof.org/file/bonesource/Clinicians-Guide.pdf. Accessed January 2, 2020.
National Osteoporosis Foundation. Osteoporosis: Review of the evidence for prevention, diagnosis and treatment and cost-effectiveness analysis. Osteoporosis Int. 1998; 8(suppl 4):1-88.
National Osteoporosis Guideline Group (NOGG). Guideline for the diagnosis and management of osteoporosis in postmenopausal women and men from the age of 50 years in the UK. March 2014. Available online at: http://www.shef.ac.uk/NOGG/NOGG_Pocket_Guide_for_Healthcare_Professionals.pdf Accessed July 5, 2018.
National Osteoporosis Society (NOS). [NOS Web site]. 2011. Available at: http://www.nos.org.uk/. Accessed July 5, 2018.
Neff MJ; American College of Obstetricians and Gynecologists (ACOG). ACOG releases guidelines for clinical management of osteoporosis. Am Fam Physician. 2004; 69(6):1558-1560.
Nelson HD, Haney EM, Chou R, et al. Screening for Osteoporosis: Systematic Review to Update the 2002 U.S. Preventive Services Task Force Recommendation. Evidence Synthesis No. 77. AHRQ Publication No. 10-05145-EF-1. Rockville, Maryland: Agency for Healthcare Research and Quality, July 2010. Available at:
Nevitt MC, Cummings SR, Stone KL, et al. Risk factors for a first-incident radiographic vertebral fracture in women less than or equal to 65 years of age: the study of osteoporotic fractures. J Bone Miner Res. 2005; 20(1):131-140.
North American Menopause Society. Management of osteoporosis in postmenopausal women. [NAMS Web site]. 2010. Available at: http://www.menopause.org/docs/default-document-library/psosteo10.pdf?sfvrsn=2. Accessed July 5, 2018
Oefelein MG, Resnick MI. The impact of osteoporosis in men treated for prostate cancer. Urol Clin North Am. 2004; 31(2):313-319.
Oregon Evidence-based Practice Center prepared to Agency for Healthcare Research and Quality (AHRQ). Screening for Osteoporosis: Systematic Review to Update the 2002 U.S. Preventive Services Task Force Recommendation. Available online at: http://www.ncbi.nlm.nih.gov/books/NBK45201/pdf/TOC.pdf. Accessed July 5, 2018.
Orwoll ES, Bevan L, Phipps KR. Determinants of bone mineral density in older men. Osteoporos Int. 2000; 11(10):815-821.
Osteogenesis Imperfecta (OI) Foundation. Bone densitometry in children and adults with OI. [OI Foundation Web site]. 02/01/98. Available at: http://www.oif.org/site/PageServer?pagename=BoneDens. Accessed July 5, 2018.
Perry HM 3rd, Morley JE. Osteoporosis in men: are we ready to diagnose and treat? Curr Rheumatol Rep. 2001; 3(3):240-244.
Qaseem A, Snow V, Shekelle P, et al. Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Screening for osteoporosis in men: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2008; 148(9):680-84.
Qaseem A, Snow V, Shekelle P, et al. Screening for osteoporosis in men: a clinical practice guideline from the American College of Physicians. Ann Intern Med. May 06 2008;148(9):680-684. PMID 18458281
Raisz LG. Clinical practice. Screening for osteoporosis. N Engl J Med.2005; 353(2):164-171.
Rajapakse CS, Chang G. Micro-finite element analysis of the proximal femur on the basis of high-resolution magnetic resonance images. Curr Osteoporos Rep. 2018;16(6):657-664.
Rojo Conejo P, Ramos Amador JT, García Piñar L, et al. Decreased bone mineral density in HIV-infected children receiving highly active antiretroviral therapy [abstract]. An Pediatr (Barc). 2004; 60(3):249-253.
Rosen CJ. Clinical practice. Postmenopausal osteoporosis. N Engl J Med. 2005; 353(6):595-603.
Rosen DS, American Academy of Pediatrics Committee on Adolescence. Identification and management of eating disorders in children and adolescents. Pediatrics. 2010; 26(6):1240-1253.
Ross PD. Risk factors for osteoporotic fracture. Endocrinol Metab Clin North Am. 1998; 27(2):289-301.
Ross RW, Small EJ. Osteoporosis in men treated with androgen deprivation therapy for prostate cancer. J Urol. 2002; 167(5):1952-1956.
Sawka AM, Papaioannou A, Josse RG, et al; The CaMos Research Group. What is the number of older Canadians needed to screen by measurement of bone density to detect an undiagnosed case of osteoporosis? a population-based study from CaMos. J Clin Densitom. 2006; 9(4):413-8.
Schousboe J, Riekkinen O, Karjalainen J. Prediction of hip osteoporsis by DXA using a novel pulse-echo ultrasound device. Osteoporos Int. 2017. 28:85-93.
Siris ES, Brenneman SK, Barrett-Connor E, et al. The effect of age and bone mineral density on the absolute, excess, and relative risk of fracture in postmenopausal women aged 50-99: results from the
National Osteoporosis Risk Assessment (NORA). Osteoporosis Int. 2006; 17(4):565-574.
Siris ES, Brenneman SK, Miller PD, et al. Predictive value of low BMD for 1-year fracture outcomes is similar for postmenopausal women ages 50-64 and 65 and Older: results from the National Osteoporosis Risk Assessment (NORA). J Bone Miner Res. 2004; 19(8):1215-1220.
Steelman J, Zeitler P. Osteoporosis in pediatrics. Pediatr Rev. 2001; 22(2):56-65.
U.S. Preventive Services Task Force (USPSTF). Osteoporosis to Prevent Fractures: Screening. Available online at: https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/osteoporosis-screening1. Accessed June 27, 2018.
U.S. Preventive Services Task Force (USPSTF). Osteoporosis: Screening to Prevent Fractures. 2018; http://www.uspreventiveservicestaskforce.org/uspstf/uspsoste.htm. Accessed January 2, 2020.
US Department of Health and Human Services, Office of the Surgeon General. The 2004 Surgeon General’s report on bone health and osteoporosis: What it means to you. [Surgeon General Web site]. Available at: http://www.ncbi.nlm.nih.gov/books/NBK45513/. Accessed July 5, 2018.
Valderas JP, Velasco S, Solari S, et al. Increase of bone resorption and the parathyroid hormone in postmenopausal women in the long-term after Roux-en-Y gastric bypass. Obes Surg. 2009; 19(8):1132-8
Vanderschueren D, Boonen S, Bouillon R. Osteoporosis and osteoporotic fractures in men: a clinical perspective (abstract). Baillieres Best Pract Res Clin Endocrinol Metab. 2000; 14(2):299-315.
Vilarrasa N, San Jose P, Garcia I, et al. Evaluation of bone mineral density in morbidly obese women after gastric bypass: 3-year follow-up. Obstet Surg. 2011; 21:465-472.
Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men: an Endocrine Society clinical practice guideline. J. Clin. Endocrinol. Metab., 2012 Jun 8;97(6). PMID 22675062
Wehren LE, Siris ES. Beyond bone mineral density: can existing clinical risk assessment instruments identify women at increased risk of osteoporosis? J Intern Med. 2004; 256(5):375-380.
Westbury LD, Shere C, Edwards MH, et al. Cluster analysis of finite element analysis and bone microarchitectural parameters identifies phenotypes with high fracture risk. Calcif Tissue Int. 2019 Jun 11 [Epub ahead of print].
Woodson GC. Risk factors for osteoporosis in postmenopausal African-American women. Curr Med Res Opin. 2004; 20(10):1681-1687.
World Health Organization (WHO). FRAX: Fracture Risk Assessment Tool. n.d.; http://www.shef.ac.uk/FRAX/tool.jsp. Accessed January 2, 2020.
Writing Group for the ISCD Position Development Conference. Diagnosis of osteoporosis in men, premenopausal women, and children. J Clin Densitom. 2004; 7(1):17-26.
Policy: 08.00.94m:Denosumab (Prolia®, Xgeva®), Romosozumab-aqqg (Evenity™)
Policy: 09.00.40d:Screening for Vertebral Fracture with Dual-Energy X-ray Absorptiometry (DEXA/DXA)
Policy: 00.06.02ac:Preventive Care Services (AmeriHealth)
Policy: 09.00.46ab:High-Technology Radiology Services (AmeriHealth)