| Coverage Policy Manual | |
| Policy #: | 1997054 |
| Category: | Radiology |
| Initiated: | July 1993 |
| Last Review: | April 2024 |
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| Bone Mineral Density Study | |
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| Description: |
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.
Osteoporosis is determined using the World Health Organization diagnostic thresholds for osteoporosis based on bone mineral density measurement (BMD) compared with a calculated T-score.
Risk factors for fracture include low bone mass, low bone strength, a personal history of fracture as an adult, or a history of fracture in a first-degree relative. Osteoporosis, defined as low bone mass leading to an increased risk of fragility fractures, is an extremely common disease in the elderly population due to age-related bone loss in both sexes and menopause-related bone loss in women. The WHO has diagnostic thresholds for osteoporosis based on BMD measurements compared with a T-score, which is the standard deviation difference between an individual’s BMD and that of a young adult reference population. Conditions that can cause or contribute to osteoporosis include lifestyle factors such as low intake of calcium, high intake of alcohol or cigarette smoking, and thinness. Other risk factors for osteoporosis include certain endocrine, hematologic, gastrointestinal tract and genetic disorders, hypogonadal states, and medications.
BMD can be measured either centrally (i.e., hip or spine) or peripherally (i.e., wrist, finger, heel). While BMD measurements are predictive of fragility fractures at all sites, central measurements of the hip and spine are the most predictive. Fractures of the hip and spine (i.e., vertebral fractures) are also considered to be the most clinically relevant. BMD is typically expressed as a T-score.
The utility of screening BMD measurements can be established by demonstrating that screening identifies a population at increased risk of fracture and that, by treating those at-risk individuals, the rate of fractures is reduced thereby lowering fracture-related morbidity and mortality. These potential benefits of screening should outweigh the risks of screening (radiation exposure) or false-positives (initiation of unnecessary treatment).
Bone Mineral Density
The decision to perform a bone density assessment should be based on an individual’s fracture risk profile and skeletal health assessment. In addition to age, sex, and BMD, risk factors included in the WHO Fracture Risk Assessment Tool are (WHO, 2022):
Dual x-ray absorptiometry (DXA) (CPT 77080 and 77081) is the most commonly used technique to measure BMD because of its ease of use, low radiation exposure, and its ability to measure BMD at both the hip and spine. Dual x-ray absorptiometry generates 2 x-ray beams of different energy levels to scan the region of interest and measures the difference in attenuation as the low- and high-energy beams pass through the bone and soft tissue. The low-energy beam is preferentially attenuated by bone, while the high-energy beam is attenuated by both bone and soft tissue. This difference in attenuation between the 2 beams allows for correction for the irregular masses of soft tissue, which surrounds the spine and hip, and therefore the measurement of bone density at those sites.
A T-score is the standard deviation difference between an individual’s BMD and that of a young adult reference population.
WHO Classification of Bone Mineral Density T-Scores:
Other Measurement Tools
Available diagnostic tools use either X-rays or ultrasound. X-ray based methods measure BMD. However, studies suggest that in addition to measuring structural aspects of the bone by assessing BMD, other mechanical features and elastic properties of the bone are also important to predict the risk of fractures. X-ray based methods cannot assess these properties and therefore use of alternative methodologies such as ultrasound densitometry and quantitative computed tomography (CT) have been explored.
Quantitative Computed Tomography
Quantitative CT (CPT 77078) depends on the differential absorption of ionizing radiation by calcified tissue and is used for central measurements only. Compared with DXA, quantitative CT is less readily available and associated with relatively high radiation exposure and relatively high cost. Analysis of previously obtained clinical CT scans of the pelvis might provide an alternative method of assessing biomechanical bone strength.
Ultrasound Densitometry
Ultrasound densitometry (CPT 76977) is a technique for measuring BMD at peripheral sites, typically the heel but also the tibia and phalanges. Compared with osteoporotic bone, normal bone demonstrates higher attenuation of the ultrasound wave and is associated with a greater velocity of the wave passing through bone. Ultrasound densitometry has no radiation exposure, and machines may be purchased for use in an office setting.
Single- and dual-photon absorptiometry (CPT 78350 and 78351) and radiographic absorptiometry are now rarely used and may be considered obsolete.
Osteoporosis Treatment
Treatment of osteoporosis includes both lifestyle measures (e.g., increased intake of calcium and vitamin D, exercise, smoking cessation) and pharmacologic measures. Current pharmacologic options include bisphosphonates such as alendronate (i.e., Fosamax®), selective estrogen receptor modulators such as raloxifene (i.e., Evista®), the recombinant human parathyroid hormone teriparatide (i.e., Forteo®), and calcitonin. A 2014 systematic review funded by the Agency for Healthcare Research and Quality found good-quality evidence that bisphosphonates, denosumab, teriparatide, and raloxifene reduce fracture risk in postmenopausal women with BMD in the osteoporotic range and/or preexisting hip or vertebral fracture (Crandall, 2014).
Regulatory Status
Devices that measure bone density have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Some examples are described below.
FDA Cleared Devices to Measure Bone Density
In addition, some ultrasound bone sonometers have been approved by the FDA through the premarket approval process. One example is the Sahara® Clinical Bone Sonometer (Hologic), which received approval in March 1998. Its intended use is for quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the determination of fracture risk.
When BMD is done for USPSTF recommended screening procedures for osteoporosis, service should be billed with modifier -33. USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women aged 65 years or older and in postmenopausal women younger than 65 years who are at increased risk of osteoporosis as determined by a formal clinical risk assessment tool.
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Policy/ Coverage: |
Effective April 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Bone mineral density measurement meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances when results are likely to influence a treatment decision:
Based on expert opinion, repeat bone mineral density measurement to evaluate response to pharmacologic treatment when this information will affect patient care, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances:
Repeat bone mineral density measurement for patients who previously tested normal and do not require pharmacologic treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes at an interval not more frequent than every 3 years to 5 years depending on the risk factors.
When axial sites are unavailable or in cases of hyperparathyroidism BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry may be medically necessary.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Screening studies are a contract exclusion and are not covered unless the contract has Wellness benefits.
The efficacy of using bone density studies to determine 'rapid bone loss' is undetermined and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, bone density studies to determine 'rapid bone loss' are considered investigational. Investigational services are an exclusion in the member benefit contract.
Peripheral bone mineral density testing using ultrasound technique is not covered for members based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. Ultrasound studies of peripheral bone (calcaneus or wrist) do not correlate well with bone mineral density determined at the hip or spine. For members with contracts without primary coverage criteria), peripheral bone mineral density testing using ultrasound technique is considered investigational. Investigational services are an exclusion in the member benefit contract.
Single and Dual photon absorptiometry do not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes. These technologies have been superseded by more effective technology. For members with contracts without primary coverage criteria, single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology.
BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry of peripheral sites does meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry of peripheral sites are considered investigational. Investigational services are an exclusion in the member benefit contract.
Trabecular bone score (TBS) to determine structural condition of the bone microarchitecture does meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes. (eff. 01/2022)
For members with contracts without primary coverage criteria, trabecular bone score (TBS) to determine structural condition of the bone microarchitecture is considered investigational. Investigational services are an exclusion in the member benefit contract.is considered. (eff. 01/2022)
The use of ultrasound-based radiofrequency echographic multi-spectrometry (REMS) in the assessment of bone density and fracture-risk does not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, the use of ultrasound-based radiofrequency echographic multi-spectrometry (REMS) in the assessment of bone density and fracture-risk is considered investigational. Investigational services are an exclusion in the member benefit contract.is considered.
Effective November 2023 through March 2024
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage
Criteria
Bone mineral density measurement meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances when results are likely to influence a treatment decision:
Based on expert opinion, repeat bone mineral density measurement to evaluate response to pharmacologic treatment when this information will affect patient care, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances:
Repeat bone mineral density measurement for patients who previously tested normal and do not require pharmacologic treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes at an interval not more frequent than every 3 years to 5 years depending on the risk factors.
When axial sites are unavailable or in cases of hyperparathyroidism BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry may be medically necessary.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
Screening studies are a contract exclusion and are not covered unless the contract has Wellness benefits.
The efficacy of using bone density studies to determine 'rapid bone loss' is undetermined and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, bone density studies to determine 'rapid bone loss' are considered investigational. Investigational services are an exclusion in the member benefit contract.
Peripheral bone mineral density testing using ultrasound technique is not covered for members based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. Ultrasound studies of peripheral bone (calcaneus or wrist) do not correlate well with bone mineral density determined at the hip or spine. For members with contracts without primary coverage criteria), peripheral bone mineral density testing using ultrasound technique is considered investigational. Investigational services are an exclusion in the member benefit contract.
Single and Dual photon absorptiometry do not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes. These technologies have been superseded by more effective technology. For members with contracts without primary coverage criteria, single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology.
BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry of peripheral sites does meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry of peripheral sites are considered investigational. Investigational services are an exclusion in the member benefit contract.
Trabecular bone score (TBS) to determine structural condition of the bone microarchitecture does meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes. (eff. 01/2022)
For members with contracts without primary coverage criteria, trabecular bone score (TBS) to determine structural condition of the bone microarchitecture is considered investigational. Investigational services are an exclusion in the member benefit contract.is considered. (eff. 01/2022)
Effective April 2017 through November 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage
Criteria
Bone mineral density measurement meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances when results are likely to influence a treatment decision:
Based on expert opinion, repeat bone mineral density measurement to evaluate response to pharmacologic treatment when this information will affect patient care, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances:
Repeat bone mineral density measurement for patients who previously tested normal and do not require pharmacologic treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes at an interval not more frequent than every 3 years to 5 years depending on the risk factors.
When axial sites are unavailable or in cases of hyperparathyroidism BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry may be medically necessary.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
Screening studies are a contract exclusion and are not covered unless the contract has Wellness benefits.
The efficacy of using bone density studies to determine 'rapid bone loss' is undetermined and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, bone density studies to determine 'rapid bone loss' are considered investigational. Investigational services are an exclusion in the member benefit contract.
Peripheral bone mineral density testing using ultrasound technique is not covered for members based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. Ultrasound studies of peripheral bone (calcaneus or wrist) do not correlate well with bone mineral density determined at the hip or spine. For members with contracts without primary coverage criteria), peripheral bone mineral density testing using ultrasound technique is considered investigational. Investigational services are an exclusion in the member benefit contract.
Single and Dual photon absorptiometry do not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes. These technologies have been superseded by more effective technology. For members with contracts without primary coverage criteria, single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology.
BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry of peripheral sites does meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry of peripheral sites are considered investigational. Investigational services are an exclusion in the member benefit contract.
Effective Prior to March 2017
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Bone mineral density measurement meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances when results are likely to influence a treatment decision:
Based on expert opinion, repeat bone mineral density measurement to evaluate response to pharmacologic treatment when this information will affect patient care, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances:
Repeat bone mineral density measurement for patients who previously tested normal and do not require pharmacologic treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes at an interval not more frequent than every 3 years to 5 years depending on the risk factors.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Screening studies are a contract exclusion and are not covered unless the contract has Wellness benefits.
The efficacy of using bone density studies to determine 'rapid bone loss' is undetermined and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, bone density studies to determine 'rapid bone loss' are considered investigational. Investigational services are an exclusion in the member benefit contract.
Peripheral bone mineral density testing using ultrasound technique is not covered for members covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. Ultrasound studies of peripheral bone (calcaneus or wrist) do not correlate well with bone mineral density determined at the hip or spine. For members with contracts without primary coverage criteria), peripheral bone mineral density testing using ultrasound technique is considered investigational. Investigational services are an exclusion in the member benefit contract.
Single and Dual photon absorptiometry do not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes. These technologies have been superseded by more effective technology. For members with contracts without primary coverage criteria, single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology.
Effective March 2005 - November 2010
Bone mineral density measurement meets primary coverage criteria for effectiveness and is covered in the following circumstances when results are likely to influence a treatment decision:
Repeat medically necessary bone mineral density measurement will be allowed:
The efficacy of using bone density studies to monitor patients to determine when there has been response to therapy has yet to be determined. The efficacy of using bone density studies to determine 'rapid bone loss' is also undetermined. In these circumstances, bone density studies are not covered based on member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, bone density studies to monitor patients to determine when there has been response to therapy or to determine 'rapid bone loss' are considered investigational. Investigational services are an exclusion in the member benefit contract.
Screening studies are a contract exclusion and are not covered unless the contract has Wellness benefits.
Peripheral bone mineral density testing using ultrasound technique is not covered for members covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. Ultrasound studies of peripheral bone (calcaneus or wrist) do not correlate well with bone mineral density determined at the hip or spine.
For members with contracts without primary coverage criteria), peripheral bone mineral density testing using ultrasound technique is considered investigational. Investigational services are an exclusion in the member benefit contract.
Single and Dual photon absorptiometry are not covered based on benefit certificate primary coverage criteria. These technologies have been superseded by more effective technology.
For members with contracts without primary coverage criteria, single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology.
Effective September 2002 – February 2005
Dual Energy X-ray Absorptiometry is covered for patients who fall into the following clinical categories: (1) Women who are deficient in estrogen; used as a means of identifying those with low bone mass and to help physicians and patients make decisions about hormone replacement therapy. (It should be understood that not all menopausal women are included in this recommendation). Many women choose not to take estrogen, and others receive hormonal replacement therapy for reasons other than the prevention of osteoporosis. This should, therefore, not be construed as a recommendation for the general screening of all menopausal women but as an approach to help women with specific problems. Screening procedures are not covered. For patients in this category, testing will be allowed no more frequently than every three to five years, if medically necessary; (2) In patients with vertebral abnormalities or roentgenographic osteopenia; (3) A baseline study for patients receiving long-term therapy with glucocorticoids, (4) In patients with primary asymptomatic hyperparathyroidism to diagnose low bone mass in order to identify those at risk of severe skeletal disease who may be candidates for surgical intervention.
The efficacy of using bone density studies to monitor patients to determine when there has been response to therapy has yet to be determined. The efficacy of using bone density studies to determine 'rapid bone loss' is also undetermined. Medically necessary Dual Energy X-ray Absorptiometry will be allowed: (1) For patients who are on therapy with Calcitonin or Bisphosphates, and the physician is assessing effectiveness of therapy (if the result of the testing is to be used to alter therapy), DEXA may be done once every eighteen months of therapy with Calcitonin or Bisphosphates to determine the effectiveness of the therapy. If the therapy is judged to be ineffective, and the physician changes to an alternate drug, re-testing within one year to test the effectiveness of the second drug is allowed. The ICD-9-CM code that is used should be one of the categories that we have listed; The type of drug listed would be Calcitonin, Bisphosphates, or Estrogen; (2) In patients receiving long-term therapy with glucocorticoids additional scans will be covered no more frequently than yearly and only if medically necessary; (3) In patients with primary asymptomatic hyperparathyroidism, repeat scans will be allowed annually if the scan result is to be used in the determination for need for surgical intervention.
Ultrasound densitometry measurement of bone mineral density is considered a screening study and is not covered.
Single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology and are not covered.
Effective July 1983 – August 2002
An ad hoc subcommittee of the Scientific Advisory Board of the National Osteoporosis Foundation prepared a document for the Health Care Financing Administration identifying four indications for measurement of bone mass that were thought to be justified by published evidence. Dual Energy X-ray Absorptiometry is covered for patients who fall into the following clinical categories: (1) Women who are deficient in estrogen; used as a means of identifying those with low bone mass and to help physicians and patients make decisions about hormone replacement therapy. (It should be understood that not all menopausal women are included in this recommendation). Many women choose not to take estrogen, and others receive hormonal replacement therapy for reasons other than the prevention of osteoporosis. This should, therefore, not be construed as a recommendation for the general screening of all menopausal women but as an approach to help women with specific problems. Screening procedures are not covered. For patients in this category, testing will be allowed no more frequently than every three to five years, if medically necessary; (2) In patients with vertebral abnormalities or roentgenographic osteopenia; (3) In patients receiving long-term therapy with glucocorticoids, the procedure may be repeated within six months of starting glucocorticoids if the result is used to reduce therapy. If a reduction in the dose of glucocorticoid is not possible despite the result of the DEXA scan, the procedure will not be covered.
Subsequent to the six-month scan, additional scans will be covered no more frequently than yearly and only if medically necessary to evaluate for rapid development of osteoporosis; (4) In patients with primary asymptomatic hyperparathyroidism to diagnose low bone mass in order to identify those at risk of severe skeletal disease who may be candidates for surgical intervention.
The efficacy of using bone density studies to monitor patients to determine when there has been response to therapy has yet to be determined. The efficacy of using bone density studies to determine 'rapid bone loss' is also undetermined. Medically necessary Dual Energy X-ray Absorptiometry will be allowed: (1) Once every two years for patients described under category one above; (2) For patients who are on therapy with Calcitonin or Bisphosphates, and the physician is assessing effectiveness of therapy (if the result of the testing is to be used to alter therapy), DEXA may be done once every eighteen months of therapy with Calcitonin or Bisphosphates to determine the effectiveness of the therapy. If the therapy is judged to be ineffective, and the physician changes to an alternate drug, re-testing within one year to test the effectiveness of the second drug is allowed. The ICD-9-CM code that is used should be one of the categories that we have listed; The type of drug listed would be Calcitonin, Bisphosphates, or Estrogen; (3) In patients receiving long-term therapy with glucocorticoids, the procedure may be repeated within six months of starting glucocorticoids if the result is used to reduce therapy. If a reduction in dose of glucocorticoid is not possible despite the result of the DEXA scan, the procedure will not be covered. Subsequent to the six-month scan, additional scans will be covered no more frequently than yearly and only if medically necessary; (4) In patients with primary asymptomatic hyperparathyroidism, repeat scans will be allowed annually if the scan result is to be used in the determination for need for surgical intervention.
Single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology and are not covered.
Ultrasound densitometry measurement of bone mineral density is considered a screening study and is not covered. (Effective July 2002)
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| Rationale: |
The National Osteoporosis Foundation (NOF) guidelines exist in 2 formats; a formal background report and a summary version presented as a “Physician’s Guide.” Although bone mineral density (BMD) measurements at the clinically relevant central sites (i.e., hip and spine) are most predictive of future fracture risk, the Physician’s Guidelines do not recommend one particular type or site of BMD testing technology, although the background report states that hip measurements are preferred. A literature search in 1999 specifically addressed the use of ultrasound densitometry of the heel, not only to assess fracture risk, but to predict response to drug therapy. Although these outcomes may seem the same, there is a subtle but important distinction. While both DXA and ultrasound densitometry were equivalent in predicting fracture risk, the correlation coefficient was only modest, suggesting that the 2 techniques identified different populations of at-risk patients. Recent randomized trials of various drug therapies, such as bisphosphonates, selective estrogen receptor modulators, and calcitonin, have all used DXA to measure therapy-induced changes in bone mineral density. Thus, it is not clear whether the results of these trials can be extrapolated to the potentially different population of at-risk patients identified by ultrasound densitometry. A literature search in 2002 focused on the use of ultrasound densitometry performed at peripheral sites other than the heel, i.e., at the phalanges or tibia. The conclusion was the same limitations regarding the evidence of ultrasonography of the heel applied to other peripheral sites. Specifically, ultrasound of any site is a poor predictor of DXA and thus cannot be used to direct patients’ treatment.
Another issue related to BMD testing is the need for serial monitoring to assess treatment response. The NOF guidelines did not explicitly address serial monitoring, although the cost effectiveness analysis in the background report assumed that the patient would undergo a single assessment of BMD. (The NOF screening guidelines were based in part on this cost-effectiveness analysis.)
For unknown reasons, treatment-related changes in BMD are not observed at peripheral sites and thus ultrasound densitometry of the heel cannot be used for serial monitoring. This suggests that if serial monitoring is considered, a central DXA BMD measurement should be the initial BMD test performed in patients at high risk for osteoporosis. A central DXA measurement will simultaneously establish the diagnosis of osteoporosis and provide a baseline.
2010 Update
A search of the MEDLINE database was conducted through September 2010.
Longitudinal changes in BMD, as a function of age and antiresorptive agents, were reported by the Canadian Multicentre Osteoporosis Study Research Group (Berger, 2008). Of a random selection of 9,423 men and women from 9 major Canadian cities, 4,433 women and 1,935 men (70%) were included for analysis. The subjects were 25 years of age or older with BMD measurements repeated 3 or 5 years apart; they tended to have better health than the 30% who did not have longitudinal data and who were excluded from analysis. Results showed that annual rates of bone loss, measured at the hip or femoral neck, increased between 25 to 85 years of age in women who were not on antiresorptive therapy, with accelerated periods of bone loss around menopausal transition (40–54 years of age) and after 70 years of age. Antiresorptive therapy, which consisted primarily of hormone replacement when the study began in 1995, was associated with attenuated bone loss across all age ranges. In women 50–79 years of age, the average loss in BMD over a 5-year period was 3.2% in nonusers of antiresorptive therapy and 0.2% in women who used antiresorptive therapy. The pattern in men was generally similar to that of women with two exceptions, BMD loss began earlier in men, and the rate of change remained relatively constant between 40 and 70 years of age. Notably, BMD at the lumbar spine did not parallel measurements at the hip and femoral neck, suggesting that vertebral bone density assessment may be obscured by degenerative changes in the spine or other artifact. The report concluded that “although current guidelines recommend that measurements of bone density be repeated once every 2–3 years, our data suggest that, at this rate of testing, the average person would exhibit change well below the margin of error, especially since only 25% of women experienced a loss of bone density that exceeded 5% over 5 years.” Poor concordance between different densitometers (e.g., Prodigy and DPX) has also been reported for BMD change measured over 2 years (Frost, 2007).
Frost and colleagues developed a prognostic model to determine the optimal screening interval for an individual without osteoporosis (defined as T-score more than -2.5) (Frost, 2009). They used prospective population-based data collected from 1,008 women and 750 men who were non-osteoporotic at baseline; participants received BMD screening every 2 years and received a median follow-up of 7.1 years. The prognostic model included the variables of age and initial BMD score; results were presented in complex tables stratified by these two variables. In the table of estimated time to reach 20% risk of sustaining a fracture or osteoporosis, most of the time estimates were 3 years or longer. The shortest time to reach a 20% risk was estimated at 2.4 years; this was for women 80 years and older with a baseline T-score of -2.2. For a typical screening candidate, a 65-year-old woman with a baseline T-score of –1.0, the estimated time to reach a 10% risk of fracture was 3.8 years and to reach a 20% risk of fracture was 6.5 years. Overall, the study suggests that the 3- to 5-year time interval included in the policy for repeat measurement of BMD in people who tested normal is reasonable, but that an individualized model could result in longer or shorter recommended re-testing intervals.
Bell and colleagues conducted a secondary analysis of data from the Fracture Intervention Trial (FIT), which randomized 6,459 post-menopausal women with low BMD to receive treatment with bisphosphonates or placebo; women underwent annual bone density scans (Bell, 2009). In their analysis, the investigators estimated between-person (treatment-related) variation and within-person (measurement-related) variation in hip and spine BMD over time to assess the value of repeat bone mineral density scans for monitoring response to treatment. After 3 years, the mean cumulative increase in hip bone mineral density was 0.30 g/cm2 in the alendronate group compared to a mean decrease of 0.012 g/cm2 in the placebo group. Moreover, 97.5% of patients treated with alendronate had increases in hip bone mineral density of at least 0.019 g/cm2, suggesting a clinically significant response. However, the study also found large within-person variability in year-to-year bone density measurements. The average within-person variation in BMD measurement was 0.013 g/cm2, which was substantially higher than the average annual increase in BMD in the alendronate group, 0.085 g/cm2. This finding suggests that the precision of BMD measurement is not reliable from year to year, and thus annual re-testing is not useful. Additional studies are needed to determine the optimal time interval for re-screening after starting bisphosphonate treatment.
Recently, there has been interest in gastric bypass surgery as a potential risk factor for osteoporosis. Several case series have found a significant decrease in BMD at one or more sites following gastric bypass surgery. For example, Carrasco and colleagues reported on a series of 42 women, mean age 38 years, who underwent gastric bypass surgery (Carrasco, 2009). A year after surgery there was a significant reduction of 3% in total BMD, reduction of 10.5% in hip BMD and reduction of 7.4% in spine BMD. Another case series by Fleischer and colleagues included 23 individuals, aged 20–64 years, who had gastric bypass surgery (Fleischer, 2008). After 1 year of follow-up, there was a significant decrease in hip BMD, a mean loss of 9.2% at the femoral neck and 8.0% of the total hip. There was not a significant difference in lumbar spine BMD. Decline in BMD was strongly associated with the extent of weight loss and the authors speculated that this change might, in part, be due to unloading of the skeleton. Moreover, the authors comment that the study had a small sample size and larger longer-term studies are needed to answer the question of how bone density loss accompanying weight loss affects bone quality and fracture risk. The 1 comparative study that was identified had a different finding as regards hip BMD. This was a retrospective cohort study by Valderas and colleagues. It included 26 post-menopausal women (mean age 58 years) who underwent Roux-en-Y gastric bypass and 26 women non-operated women matched for age and body mass index (Valeras, 2009). After a mean of 3.1 years after surgery, the mean decrease in femoral neck BMD s 0.892 g/cm2 in the gastric bypass group and 0.934 cm2 in the comparison group; this difference was not statistically significant. Differences in lumbar spine BMD also did not differ significantly. Two clinical guidelines, the National Osteoporosis Foundation (NOF) and the American Association of Clinical Endocrinologists (AACE) list gastric surgery as one of many factors linked to an increased risk of osteoporosis or fracture.
Technology Assessments, Guidelines and Position Statements
The NOF updated its practice guidelines in 2008. Current NOF guidelines recommend that all postmenopausal women and older men should be evaluated clinically for osteoporosis risk to determine the need for BMD testing. In general, the more risk factors that are present, the greater the risk of fracture. BMD assessment is indicated in:
The NOF guidelines suggest that BMD measurement is not indicated unless the results will influence the patient’s treatment decision, and that serial monitoring of BMD is appropriate for monitoring bone loss in patients on pharmacotherapy (commonly performed at 2-year intervals). These guidelines are based on economic analysis that takes into consideration the cost effectiveness of treatments and competition for resources in the United States. NOF analysis concluded that it is cost effective to treat individuals with a prior fracture and those with BMD T scores below -2.5 in the absence of other risk factors, and in individuals with BMD T scores between -1.0 and -2.5 (osteopenia), if other risk factors are present (this is a change from prior recommendations).
The U.S. Surgeon General published a report on bone health and osteoporosis in 2004. DXA measurements were considered precise enough to be used for monitoring patients over time, provided the interval between measurements is tailored to the specific patient’s situation. Several points were made regarding the most appropriate approaches for BMD monitoring.
Guidelines from the U.S. Preventative Services Task Force (USPSTF) in 2002 recommend that women aged 65 and older should be screened routinely for osteoporosis with bone density measurements. The USPSTF recommends that routine screening begin at age 60 for women at increased risk for osteoporotic fractures and “makes no recommendation for or against routine osteoporosis screening in postmenopausal women who are younger than 60 or in women aged 60–64 who are not at increased risk for osteoporotic fractures.” The available evidence indicated that screening women at lower risk can identify women who may be eligible for treatment, but it would prevent a small number of fractures. Regarding repeat testing, the report states that no studies have evaluated the optimal intervals for repeated screening. “Because of limitations in the precision of testing, a minimum of 2 years may be needed to reliably measure a change in bone mineral density; however, longer intervals may be adequate for repeated screening to identify new cases of osteoporosis. Yield of repeated screening will be higher in older women, those with lower BMD at baseline, and those with other risk factors for fracture. No data were available to determine the appropriate age to stop screening. An updated literature review for the USPSTF recommendation on osteoporosis screening (Nelson, 2010) was published in July 2010. The findings from this review, do not impact the coverage statement. The USPSTF posted a draft of their updated guidelines for public comment but have not finalized the updated guidelines at the time of this policy update.
2008 guidelines from the American College of Physicians (ACP) recommend that clinicians periodically perform individualized assessment of risk factors for osteoporosis in men older than 50 years (Grade: strong recommendation; moderate-quality evidence). Factors that increase the risk for osteoporosis in men include age (>70 years), low body mass index (BMI), weight loss, physical inactivity, corticosteroid use, androgen deprivation therapy, and previous fragility fracture. The ACP recommends that clinicians obtain DXA for men who are at increased risk for osteoporosis and are candidates for drug therapy (Grade: strong recommendation; moderate-quality evidence). The guidelines indicate that bone density measurement with DXA is the accepted reference standard for diagnosing osteoporosis in men; because treatment trials have not measured the effectiveness of therapy for osteoporosis diagnosed by ultrasound densitometry rather than DXA, the role of ultrasound in diagnosis remains uncertain. This evidence review found no studies that evaluated the optimal intervals for repeated screening by using BMD measurement with DXA in men.
Practice guidelines from the American College of Radiology (ACR), amended in 2006 and 2007, recommend that BMD measurement is indicated whenever a clinical decision to intervene will be directly influenced by the result of the test (Bradford, 2007). The ACR states that BMD measurement is used to identify patients with low bone density and increased fracture risk or patients being monitored to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy, with DXA being the gold standard and the only BMD technology for which WHO criteria for diagnosis of osteoporosis, originally for postmenopausal Caucasian women over age 65, can be used. Follow-up for treatment can be performed using DXA and QCT only and “should be performed at appropriate intervals as indicated.” All other measurements are peripheral and for identifying individuals at risk for fracture and low BMD (pDXA, pQCT, SXA, QUS). Hyperparathyroidism is an exception to routine BMD testing in which the forearm is essential for diagnosis. Another exception is pediatric patients in whom DXA can measure spine, but total body calcium is preferred because it helps reduce the issue of following patients with growing bones.
Guidelines from the American College of Obstetricians and Gynecologists (ACOG) from 2004 indicate that testing of BMD should be performed on the basis of an individual woman’s risk profile and is not indicated unless the results will influence a treatment or management decision. The following guidelines were recommended:
ACOG recommends that in the absence of new risk factors, subsequent screening should not be performed more frequently than every 2 years. The usefulness of repeated screening will be greater in older women, those with lower baseline BMD, and those with numerous risk factors. For older women who have experienced an osteoporotic vertebral fracture, treatment may be given without BMD measurement, although baseline BMD testing may be useful to follow the effects of therapy. A non-vertebral fracture (e.g., hip or wrist) is, by itself, not an indication for treatment in the absence of low BMD. Testing of BMD in early postmenopausal women may be of value in helping women make a decision about preventive therapy; however, it cannot be justified on the basis of fracture reduction in the short term.
Guidelines from the American Association of Clinical Endocrinologists (AACE), published in 2003, indicate that in women who are at risk for postmenopausal osteoporosis, BMD measurement can accomplish the following:
Specifically regarding serial BMD measurements, the AACE guidelines state that they are “useful for monitoring changes in bone mass. Each technique for evaluation of bone density has an inherent variability (that is, precision error) that must be considered when the clinical significance of BMD changes is assessed…..Until specific data about the most efficient use of BMD for monitoring become available, the following general guidelines for performing follow-up BMD measurements may be used:
The American College of Rheumatology Ad Hoc Committee on Glucocorticoid-Induced Osteoporosis (2001) recommends obtaining a baseline measurement of BMD at the lumbar spine and/or hip when initiating long-term (i.e., >6 months) glucocorticoid therapy. Longitudinal measurements may be repeated as often as every 6 months for monitoring glucocorticoid-treated patients to detect bone loss. In patients who are receiving therapy to prevent bone loss; annual follow-up measurements are probably sufficient.
The Institute for Clinical Systems Improvement (ICSI) recommends:
The bone density testing in individuals as follows:
The 2007 International Society for Clinical Densitometry (ISCD) guidelines recommend bone density testing in the following patients:
The 2010 position statement of The North American Menopause Society recommends the following:
2011 Update
In January 2011, the U.S. Preventative Services Task Force (USPSTF) issued updated recommendations on screening for osteoporosis with bone density measurements. The USPSTF recommends routine osteoporosis screening in women age 65 years or older, and in younger women whose risk of fracture is at least equal to that of a 65-year old average-risk white woman. This represents a change from the previous (2002) version in which there was no specific recommendation regarding screening in women younger than 65 years old. The supporting document notes that there are multiple instruments to predict risk for low BMD, and that the USPSTF used the FRAX tool. The FRAX tool can be accessed online at: http://www.shef.ac.uk/FRAX/. The USPSTF recommends using a 9.3% 10-year fracture risk threshold to screen women between the ages of 50 and 64 years. The updated USPSTF recommendations state that the scientific evidence is insufficient to recommend for or against routine osteoporosis screening in men. The Task Force did not recommend specific screening tests, but said that the most commonly used tests are DXA of the hip and lumbar spine and quantitative ultrasound of the calcaneus. The recommendations state the following on screening intervals: “…A lack of evidence exists about the optimal intervals for repeat screening and whether repeated screening is necessary in a woman with normal BMD. Because of limitations in the precision of testing, a minimum of two years may be needed to reliably measure a change in BMD; however, longer intervals may be necessary to improve fracture risk prediction.”
2012 Update
A literature search conducted through September 2012 did not identify any new information that would prompt a change in the coverage statement.
2013 Update
A search of the MEDLINE database was conducted through September 2013. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
A 2012 multicenter prospective study by Gourlay and colleagues provided data on the optimal bone density screening interval in a large cohort of women with normal BMD or osteopenia at an initial screen (Gourlay, 2012). The investigators included a total of 4,957 women age 67 years or older who had BMD data at 2 or more examinations or at one examination before a competing risk event (hip or clinical vertebral fracture). More than 99% of the sample reported they were white. The study only included women who were candidates for osteoporosis screening. Other women, such as those with osteoporosis at baseline or with a history of a hip or clinical vertebral fracture were excluded, as they would already be candidates for pharmacological treatment (Hillier, 2007). The primary study outcome was the estimated time interval for 10% of participants to make the transition from normal BMD or osteopenia at baseline to osteoporosis before a hip or clinical vertebral fracture occurred and before starting osteoporosis treatment. For women with normal BMD at baseline, the estimated BMD testing interval was 16.8 years (95% confidence interval [CI]: 11.5 to 24.6). The study found that the estimated BMD testing interval was 17.3 years (95% CI: 13.9 to 21.5) for women with mild osteopenia at baseline, 4.7 years (95% CI: 4.2 to 5.2) with moderate osteopenia, and 1.1 years (95% CI: 1.0 to 1.3) for women with advanced osteopenia. Findings of this study have not been incorporated into national guidelines.
In 2012, the American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines on managing osteoporosis in women (ACOG, 2012). The guidelines recommend that BMD screening should begin for all women at age 65 years. In addition, they recommend screening for women younger than 65 years in whom the Fracture Risk Assessment (FRAX) Tool indicates a 10-year risk of osteoporotic fracture of at least 9.3%. Alternatively, they recommend BMD screening women in younger than 65 or with any of the following risk factors (these are similar, but not identical to risk factors in FRAX):
2014 Update
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2014, Gadam et al performed a cross-sectional analysis of data to evaluate the incremental predictive ability of BMD when added to the FRAX model. The study included 151 subjects (145 women, 6 men) older than 50 years of age without a prior osteoporosis diagnosis and who were not being treated with U.S. Food and Drug Administration (FDA)-approved medications for treating osteoporosis (Gadam, 2013). Of the 151 individuals, predictions of 10-year fracture risk were identical for 127 patients (84%) when BMD was added to the FRAX model compared with the FRAX model without BMD. Of the subjects who had different risk estimates, the difference in risk prediction resulted in an additional 2 patients meeting the NOF threshold for treatment when BMD was added to the FRAX model. Age was the only risk factor that differed significantly between participants with identical versus different recommendations (p<0.001). Subjects who were younger (mean age, 64 years) were more likely to receive identical predictions than older subjects (mean age, 76 years). The study had a relatively small sample size and lacked longitudinal data on fracture. It provides some initial evidence that BMD may not add substantially to the predictive ability of the FRAX models, but these findings need to be corroborated in prospective studies with larger sample sizes.
Other studies suggesting that a longer time interval may be used or that repeat BMD measurements may not be critical include a 2007 study by Hillier et al. The study did not find that follow-up BMD measurements 8 years after a baseline screen provided substantial value in terms of predicting risk of fracture The study included 4124 women age 65 years and older and assessed total hip BMD at initial and follow-up screening examinations. In analyses adjusted for age and weight change, the initial and repeat BMD measurements had similar associations with fracture risk; this included risk of vertebral fractures, nonvertebral fractures, and hip fractures. Stratifying the analysis by initial BMD T scores (ie, normal, osteopenic, osteoporotic) did not alter findings. Moreover, a 2013 study by Berry et al did not find that changes in BMD 4 years after initial measurement added substantially to the prediction of fracture risk in untreated subjects (Berry, 2013). The authors conducted a population-based cohort study including 210 women and 492 men (mean age, 75 years) who had 2 BMD measurements a mean of 3.7 years apart and did not have a hip fracture before the second test. Median follow-up was 9.6 years after the second BMD test. During this time, 76 individuals experienced a hip fracture and 113 had a major osteoporotic fracture (fracture of the hip, spine, forearm or shoulder). In receiver operating curve (ROC) analyses, adding repeat BMD to a model containing baseline BMD did not meaningfully improve the model’s ability to predict hip fracture (area under the curve [AUC], 0.72; 95% CI, 0.66 to 0.79). When percent change in BMD was used, the AUC was 0.71 (95% CI, 0.65 to 0.78) in a model including only baseline BMD and 0.68 (95% CI, 0.62 to 0.75) in a model including percent change in BMD.
Practice guidelines from the American College of Radiology (ACR), last amended in 2010, state that BMD measurement is usually appropriate in the following patient populations (ACR, 2014):
2015 Update
A literature search conducted through April 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Serial Measurement of Central BMD to Monitor Discontinuation of Treatment
In 2014, Bauer and colleagues reported fracture risk prediction among women who discontinued alendronate after 4 to 5 years of treatment in the FLEX (Fracture Intervention Trial Long-term Extension) study (Bauer, 2014). Women aged 61 to 86 years who had previously been treated with alendronate were randomized to 5 more years of alendronate or to placebo. A prior report of this study found that although hip BMD decreased in the placebo group, rates of fracture were similar between the group randomized to placebo and the group that continued on bisphosphonate therapy (Black, 2006). It should be noted that alendronate has a half-life in humans that is estimated to exceed 10 years (Gourlay, 2014). During the 5 years of placebo, 94 of 437 women (22%) experienced 1 or more symptomatic fractures; most of these (87%) occurred after 1 year. Post-hoc analysis found that older age and lower hip (but not spine) DXA at time of discontinuation were significantly related to increased fracture risk; however, changes in BMD between the beginning of discontinuation to years 1 and 3 were not.
There is a lack of evidence of a clinical benefit of serial measurement of BMD for patients who have discontinued pharmacologic osteoporosis treatment.
National Osteoporosis Foundation
The National Osteoporosis Foundation (NOF) updated its practice guidelines in 2014 (NOF, 2014). NOF guidelines recommend that all postmenopausal women and men age 50 and older should be evaluated clinically for osteoporosis risk to determine the need for BMD testing.
Indications for BMD testing are:
NOF states that measurements for monitoring patients should be performed in accordance with medical necessity, expected response and in consideration of local regulatory requirements. NOF recommends that repeat BMD assessments generally agree with Medicare guidelines of every two years, but recognizes that testing more frequently may be warranted in certain clinical situations.
NOF also indicates that “Central DXA 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 percent at the hip and 2-4 percent at the spine from test to test may be due to the precision error of the testing itself.”
American College of Radiology
Practice guidelines from the American College of Radiology, last amended in 2014 (ACR, 2014) state that BMD measurement is usually appropriate in the following patient populations indicated whenever a clinical decision is likely to be directly influenced by the result of the test. Indications for DXA include but are not to the following patient populations:
International Society for Clinical Densitometry
The 2013 update of the International Society for Clinical Densitometry guidelines recommend bone density testing in the following patients (ISCD, 2013):
In 2010 the American Association of Clinical Endocrinologists issued guidelines for the diagnosis and treatment of postmenopausal osteoporosis.25 The guidelines list the potential uses for BMD measurements in postmenopausal women as:
The North American Menopause Society issued a 2010 position statement 26 which states that fracture is the most significant risk of low bone density. The statement also concludes that Bone Mineral Density (BMD) is an important determinant of fracture risk, especially in women 65 years and older.
2017 Update
A literature search conducted through February 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Crandall and colleagues reported results from 11,392 participants in the Women’s Health Initiative (WHI) BMD Cohort, a prospective observational study of postmenopausal women with a mean follow-up of 8.5 years (Crandall, 2015). Each standard deviation decline in lower BMD measured with central DXA was associated with higher wrist fracture risk, the adjusted hazard ratio (HR) being 1.7 (95% CI, 1.4 to 1.9) for femoral neck BMD and 1.5 (95% CI, 1.3 to 1.6) for lumbar spine BMD.
Cauley and colleagues reported risk factors for hip fractures in 5994 men with a mean of 8.6 years of follow-up from the Osteoporotic Fractures in Men Study (Cauley, 2016). Femoral neck BMD was measured using DXA. The incidence rate of hip fracture 33.4 per 1000 person-years in men with BMD T scores less than -2.5 who also had 4 or more risk factors, 14.5 per 1000 person-years in men age 80 years and older with 3 or more major comorbidities, and 0.88 per 1000 person-years in men age less than 70 years with zero comorbidities. Low BMD by World Health Organization classification (T score < -2.5 ) was highly associated with hip fracture (hazard ratio [HR], 3.3; 95% CI, 2.7 to 3.9) in a competing risk model after adjusting for several other fracture risk factors (eg, age, previous fracture).
Leslie and colleagues reported on repeat BMD measurements in clinical practice for fracture risk assessment from a large clinical BMD database for Manitoba, Canada, of women and men ages 50 years and older from 1990 to 2009 (Leslie, 2016). BMD was measured in the hip, lumbar spine, and femoral neck using DXA. A total of 50,215 participants had 1 BMD measurement, 14,619 had a second measurement, 4722 had a third measurement, and 1500 had a fourth measurement. The mean time between measurements was 4.2 years. Total hip BMD was predictive of major osteoporotic fracture at each time point. The association between BMD and major osteoporotic fracture was similar for the first and second BMD measurements: adjusted hazard ratios per standard deviation were 1.5 (95% CI, 1.3 to 1.6) and 1.6 (95% CI, 1.5 to 1.8), respectively. The hazard ratio for the second measurement was similar when stratified by preceding change in BMD or osteoporosis therapy.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Initial Measurement of Bone Mineral Density
A 2018 systematic review for the U.S. Preventive Services Task Force (USPSTF) evaluated the evidence on screening for osteoporosis (USPSTF, 2018). The review considered centrally measured DXA to be the reference standard against which other screening measures were evaluated. Randomized controlled trials included in the systematic review have shown that osteoporosis medications are effective at reducing fracture risk in postmenopausal women with BMD in the osteoporotic range identified by central DXA. A noted limitation of the review was that treatment studies relied on DXA BMD scores to enroll participants into trials and that risk factors beyond bone density, such as bone quality, contribute to osteoporotic fractures. Therefore, “approaches that rely on BMD measurement wholly or in part may not be the most accurate approaches for identifying patients at highest risk for osteoporotic fractures.”
Repeat Measurement Of Bmd For Individuals Without Osteoporosis On Initial Screen
The 2018 USPSTF systematic review of the evidence on screening interval identified 2 studies with variable BMD that suggested no advantage to repeated bone measurement testing (Hillier, 2007; Berry, 2013). However, prognostic modeling from other studies suggested that the optimal screening interval varies by baseline BMD, and that age and use of hormone replacement therapy might also influence optimal screening intervals (Frost, 2009; Gourlay, 2012; Gourlay, 2015). Review of evidence by the Agency for Healthcare Research and Quality Sourthern California Evidence-Based Practice Center for the American College of Physicians identified moderate quality evidence that women do not require requent monitoring, with 10% of women with normal or mildly osteopenic DXA scores progressing to osteopenia within 15 years (Qaseem, 2017; AHRQ, 2012).
Serial Measurement of Central BMD to Monitor Response to Pharmacologic Treatment
Several moderate quality studies included in the Agency for Healthcare Research and Quality report showed that fracture risk may be reduced with pharmacologic treatment even when BMD does not Increase (Qaseem, 2017; AHRQ, 2012). In the Fracture Intervention Trial, 6459 women randomized to bisphosphonates or to placebo underwent annual bone density scans. A secondary analysis found an average within-person variation in BMD measurement of 0.013 g/cm2,which was substantially higher than the average annual increase in BMD (0.0085 g/cm2) in the alendronate group (Bell, 2009).
Ultrasound Densitometry, Or Quantitative Computed Tomography, Or Dxa Analysis Of Peripheral Sites
In the review of evidence for the USPSTF, 10 studies were identified that compared calcaneal quantitative ultrasound to central DXA (USPSTF, 2018). Pooled estimates of area under the curves were 0.77 (95% CI, 0.72-0.81; 1969 participants) in women and 0.80 (95% CI, 0.67-0.94; 5142 participants) in men. Similar findings were observed for digital x-ray radiogrammetry, peripheral DXA, and radiographic absorptiometry. For predicting osteoporotic fractures, no meaningful differences in accuracy by type of bone test were observed. A study by Adams et al is consistent with the results of the USPSTF systematic review, showing the prediction of fracture with a “biomechanical” computed tomography analyzed on previously taken clinical computed tomography scans that were at least as good as DXA (Adams, 2018). No studies were identified that guided treatment based on computed tomography scan results.
Practice Guidelines and Position Statements
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 (Ward, 2017). Indications for DXA of the lumbar spine and hip included but were not limited to the following patient populations:
U.S. Preventive Services Task Force Recommendations
The USPSTF updated its recommendations on screening for osteoporosis with bone density measurements (USPSTF, 2018). 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. 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.
2020 Update
A literature search was conducted through March 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 March 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
The American Association of Clinical Endocrinologists and the American College of Endocrinology published joint guidelines on the diagnosis and treatment of postmenopausal osteoporosis (Camacho, 2020).
For patients on osteoporosis pharmacotherapy, the guidelines recommended obtaining a baseline DXA and repeating DXA every 1 to 2 years until findings are stable. Successful treatment of osteoporosis was defined as stable or increasing BMD with no evidence of new fractures or vertebral fracture progression. The guidelines recommended continued follow-up every 1-2 years or at a less-frequent interval, depending on clinical circumstances. They also noted that follow-up of patients should ideally be conducted in the same facility with the same machine.
Recommendations on length of treatment were as follows:
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through March 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 March 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
For women who are being treated for osteoporosis, the guidelines recommended BMD testing with central DXA every 1 to 3 years to assess response to treatment. In women who are taking bisphosphonates, the guideline authors recommended reassessment of fracture risk after 3 to 5 years (5 years for oral, 3 for intravenous) with clinical risk assessment and BMD testing. Women who remain at high-risk of fractures should continue therapy, whereas those who are at low- to moderate-risk of fractures should be considered for a “bisphosphonate holiday. "Once a bisphosphonate holiday is initiated, fracture risk should be reassessed every 2 to 4 years. Clinicians should consider reinitiating osteoporosis therapy earlier than the 5-year suggested maximum if there is a significant decline in BMD, a fracture, or other factors that alter the clinical risk status. For women taking denosumab, the guideline authors recommended reassessment of fracture risk with BMD and clinical risk assessment after 5 to 10 years. Women who remain at high-risk of fractures should either continue denosumab or be treated with other osteoporosis therapies. These guidelines were updated in 2020, but no changes were made to the DXA recommendations (Shoback, 2020).
In 2021, the American College of Obstetricians and Gynecologists (ACOG) released clinical practice guidelines on the prevention, screening, and diagnosis of osteoporosis which was an update from their 2012 osteoporosis guidelines (Chelmow, 2021). The guidelines recommend bone mineral density (BMD) screening in all women 65 years and older to prevent osteoporotic fractures. In addition, ACOG recommends screening for women younger than 65 years who are at increased risk of osteoporosis, with at least 1 risk factor, as listed below, or as determined by a formal clinical risk assessment tool. For example, a woman younger than 65 years of age may benefit from BMD screening if the Fracture Risk Assessment Tool indicates a 10-year risk of osteoporotic fracture of at least 8.4%. Risk factors that may put women younger than 65 at an increased risk include any of the following risk factors (they are similar, but not identical to risk factors in the Fracture Risk Assessment Tool):
ACOG also recommends repeat osteoporosis screening in postmenopausal women with initial BMD test results near treatment thresholds or with any significant changes in risk factors. For most patients, repeat BMD testing should be performed no sooner than 2 years after initial screening.
The 2017 guidelines from the American College of Physicians 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) (Qaseem, 2017). 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 DXA [dual-energy x-ray absorptiometry] scores did not progress to osteoporosis within 15 years.”
The 2019 update of the International Society for Clinical Densitometry official position statements recommended bone density testing in the following patients (ISCD, 2019):
The 2019 position statement makes the following recommendations on serial BMD measurements:
In 2022, the Bone Health and Osteoporosis Foundation (BHOF), formerly known as the National Osteoporosis Foundation, updated its practice guidelines (LeBoff, 2022). The BHOF guidelines state that bone density measurements are not indicated unless test results will influence treatment and management decisions.
Indications for BMD testing recommended by the BHOF include:
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
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 DXA [dual-energy x-ray absorptiometry] scores did not progress to osteoporosis within 15 years.” These guidelines were updated in 2023, but BMD monitoring was not addressed in the update (Qaseem, 2023).
The 2022 update of appropriateness criteria from the American College of Radiology states that BMD measurement is indicated whenever a clinical decision is likely to be directly influenced by the result of the test (Yu, 2021). Indications for dual x-ray absorptiometry (DXA) of the lumbar spine and hip included but were not limited to the following patient populations:
Radiofrequency echographic multispectrometry (REMS) is a nonionizing technology for the densitometric assessment of osteoporosis. In a large, multicenter European study, REMS was able to discriminate patients with and without osteoporosis (DXA T-score equal to or less than -2.5) at the femoral neck with sensitivity and specificity of 90.4 and 95.5 percent, respectively; for the lumbar spine scans, sensitivity was 90.9 percent and specificity was 95.1 percent (Cortet, 2021).
REMS can provide insight into skeletal properties, but it is used primarily in research settings and its role in clinical practice is yet to be defined (Lewiecki, 2024).
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Adams AL, Fischer H, Kopperdahl DL, et al.(2018) 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 Adams JE, Ring EFJ, Eastell R(2001) Position statement on the use of peripheral x-ray absorptiometry in the management of osteoporosis. www.nos.org.uk; 2001. Agency for Healthcare Research and Quality.(2012) 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 November 18, 2018. American Association of Clinical Endocrinologists(2010) Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Postmenopausal Osteoporosis Endocr. Pract. 2010; 16 Suppl 3: 1-37. 2010. 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