Guideline

Risk factors, fracture risk assessment and case-finding

Case-finding and screening

Osteoporosis management and fracture prevention in post-menopausal women and men > 50 years of age
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Case-finding and screening

Recommendation 7

Grade

Those aged >50 years with a current or prior minimal trauma fracture should be assessed and appropriately treated.

A

Recommendation 8

Grade

For those aged >50 years with lifestyle and non-modifiable risk factors (eg parent with hip fracture) use FRAX® to calculate absolute fracture risk.

When FRAX® risk for major osteoporotic fracture (MOF) is ≥10%, refer for DXA. If the risk of MOF is <10%, DXA is not recommended.

Re-stratify risk with FRAX® after DXA using BMD reading and treat when:

  • BMD T-score is ≤–2.5
  • BMD T-score is between –1.5 and –2.5 and the FRAX® risk for MOF is ≥20% and/or the hip fracture risk is ≥3%.

D

Recommendation 9

Grade

For those aged >50 years with diseases/chronic conditions/medications associated with increased fracture risk, refer for BMD assessment by DXA.

Re-stratify risk with FRAX® after DXA using BMD reading and treat when:

  • BMD T-score is ≤–2.5
  • BMD T-score is between –1.5 and –2.5 and the FRAX® risk for MOF is ≥20% and/or the hip fracture risk is ≥3%.

C

Recommendation 10

Grade

There is insufficient evidence to recommend population-based systematic screening with BMD measurement for reduction of osteoporotic fractures in Australia, and case finding is recommended.

B

Screening is the application of a test or assessment to asymptomatic people in defined parts of the population. This can be organised proactively, as seen for bowel or breast cancer, or opportunistically when a person interacts with a health service for other reasons. The case for screening in osteoporosis is for primary prevention of fractures. Case finding is aimed at individuals who would likely accept and benefit from further assessment or investigation. Patients with a previous osteoporotic fracture should be considered for treatment, not screening. As discussed in the Background section, large numbers of people suitable for secondary fracture prevention treatment are being missed, and systems such as osteoporosis refracture prevention programs to identify them are recommended. Active case finding for prior fragility fracture should be considered by radiology services, hospitals and general practitioners.

Currently, there is no universally accepted policy for population-based screening to identify people likely to benefit from osteoporosis treatment.1 There have been three recent large population-based RCTs of screening in women for the prevention of osteoporotic fractures: Screening in the Community to Reduce Fractures in Older Women (SCOOP) in the UK,2 Risk-stratified Osteoporosis Strategy Evaluation (ROSE) in Denmark,3 and SALT Osteoporosis Study (SOS) in the Netherlands.4 None of these RCTs showed a reduction in their primary outcome of all fractures; however, there was a trend to a reduction. The planned secondary end point of a reduction in hip fractures showed a significant result in one trial and a consistent trend in the other two.2–4 This resulted in a significant result for hip fracture reduction in a meta-analysis (which included n>42,000 in total), with an absolute risk reduction of 0.47% over five years of treatment.5 Although this is promising, optimal thresholds of absolute fracture risk and implementation strategies are inadequately defined for the Australian context and there are no data on screening for men. Accordingly, there is currently insufficient evidence to support a population-based screening program in Australia.

Consequently, a case finding strategy is appropriate where patients are identified because of the presence of other clinical risk factors and if they are interested to know their fracture risk to make an informed decision regarding treatment/management, as appropriate.

An important application for fracture risk calculators is to improve the selection of individuals in whom to recommend treatment. Individuals who have not fractured but are in the osteoporotic BMD range or middle-aged to older individuals with prior minimal trauma fracture generally have high calculated absolute fracture risk, supporting a recommendation for treatment. Individuals with BMD values within the osteopenic range but without a prior fracture are more likely to benefit from fracture risk algorithms. In this group, a high fracture risk estimate may change management and lead to therapy recommendation. Health economic modelling in the UK6,7 and the US8 has demonstrated that treatment is cost-effective when FRAX® is used to identify at-risk patients. Based on a drug cost of US$600 per year for five years (with 35% fracture reduction) and an average cost per QALY designated at US$60,000 or less, the US National Osteoporosis Foundation guidelines recommend treatment when the 10-year risk of hip fracture estimated by FRAX® is ≥3% or the 10-year risk of major osteoporotic fracture is ≥20%.9

One of the challenges in managing patients suspected of having osteoporosis and at increased risk of fracture is understanding how fracture risk assessment tools, bone densitometry, and the use of anti-osteoporosis therapies can fit together to benefit patients.

A check for the presence of risk factors is reasonable from the age of 50 years onwards because the prevalence of risk factors increases from this age upwards. Risk factors and the influence of sex can be incorporated into a better understanding of an individual’s risk through use of an absolute risk calculator. There are many clinical risk factors for fracture in addition to those included in FRAX® that can be used to trigger fracture risk assessment (e.g., inflammatory arthritis or coeliac disease). Several diseases (e.g., rheumatoid arthritis, thyroid disease) and medications (e.g., corticosteroids) on their own are also regarded as sufficient risks for osteoporosis to warrant BMD measurement. This implies the use of FRAX®-based risk estimation prior to BMD is most relevant to those weaker clinical risk factors and age (refer to the ‘Osteoporosis risk assessment, diagnosis and management flow chart’). Clinical judgment is needed when clinical risks exceed those that can be incorporated into a FRAX® assessment. This approach of recommending a BMD on the basis of FRAX® risk has been adopted in several countries.1 The use of a risk estimation tool such as FRAX® also removes the need to set different minimum ages for initial risk enquiry for men and women because sex is part of the risk estimation algorithm.

The absolute risk at which to recommend DXA and the threshold for treatment, especially pharmacotherapy, is important, yet not consistently defined. The level of risk perceived as ‘high’ will vary between individuals and may differ from the point of view of a funder. Bone density alone is not sensitive for predicting fragility fractures given that most fragility fractures occur in people in the osteopenic range. This can be improved by the use of absolute risk estimation tools, but at the expense of added complexity for the clinician. However, almost all anti-osteoporosis treatments have been studied in RCTs of patients with low BMD values and/or prior fracture rather than based on absolute risk estimation. Three trials allow an estimate of absolute risk at which treatment is effective, as detailed below.

In the Fracture Intervention Trial (FIT) trial (oral alendronate), which was effective at reducing fractures, 90% had a baseline 10-year fracture risk >14%, with virtually all having a risk >10%.10 In the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every Six Months (FREEDOM) trial, the median baseline 10-year fracture risk was 15%.11 Denosumab seemed effective for those with a baseline 10-year fracture risk >12%.11 In the third trial, which evaluated zoledronate in osteoporotic women aged >65 years, zoledronate was effective, with a median baseline absolute risk of 12% for fracture at 10 years.12

The thresholds used in the screening trials can also inform the decision to refer for DXA. The ROSE study used a threshold of 15% 10-year fracture risk (FRAX®) to recommend DXA testing.3 The SCOOP trial used a range of age-specific thresholds (3.4% at 50 years, rising to 11.1% 10-year risk of major osteoporotic fracture at 70 years),2 which may make implementation in the Australian primary care setting difficult without clinical decision support software or a graphic reference of risk thresholds by age.

Given that case finding would be used for a population selected for their interest to engage in fracture prevention interventions, the impact can be expected to be better than demonstrated in the population screening trials. A slightly lower threshold for recommending BMD assessment has been adopted, as was done in the Scottish Intercollegiate Guidelines Network 2021,13 where a 10-year risk of major fracture of >10% triggers a recommendation for BMD measurement, which is relatively pragmatic and inclusive. A patient’s personal meaning and value placed on a risk estimate should also guide the next steps.

Economic modelling of potential population screening regimens suggests a higher risk threshold is needed to be cost-effective. The absolute risk thresholds for cost-effectiveness were similar across ethnic and racial groups, and slightly higher for men. This assumes five years of full medication adherence. A 2013 Japanese study suggested screening women with a 10-year risk of osteoporotic fracture >26% would be cost-effective at US$50,000/QALY.14

Evidence statement for population screening

The SCOOP RCT recruited woman aged 70–85 years from primary care practices in the UK and showed that a screening program using FRAX® first, followed by DXA in those at high risk of hip fracture (probability 5.2–8.5%, depending on age), was associated with a reduction in hip fracture incidence (hazard ratio [HR] 0.72; 95% CI: 0.59–0.89) compared with those undergoing usual care.2 However, there was no reduction in the prespecified primary outcome of all osteoporosis-related fractures. The use of bone-protective therapy was also higher in the screened group and, in subsequent analysis, medication adherence was increased, even out to 60 months.5 Of note, fracture probability was then recalculated using the BMD result, and those with a fracture risk above the intervention threshold (hip fracture probability between 5.24% and 8.99%, depending on age) were advised to make an appointment with their GP to discuss potential treatment.2 The GP was also informed about the screening result.

The Danish community-based ROSE study enrolled woman aged 65–80 years and used data obtained from a self-administered questionnaire to calculate an absolute risk of fracture using FRAX®, followed by a DXA scan in women with moderate-to-high fracture risk (≥15% at 10 years).3 Unlike the SCOOP trial, there was no difference in fracture incidence between the screening and control groups in the intention-to-treat analysis, possibly because treatment decisions were based on DXA results only.3 However, another randomised large community-based Dutch study of women aged 65–90 years examined the effect of a screening program involving DXA, vertebral fracture assessment and FRAX®, and failed to show a reduction in fractures compared with usual GP care.4 However, this may have been affected by suboptimal patient participation and incomplete medication adherence.

Due to concern that the above individual studies may have been underpowered, a subsequent meta-analysis was undertaken and found a statistically significant reduction in osteoporotic fractures (HR 0.95; 95% CI: 0.89–1.00), major osteoporotic fractures (HR 0.91; 95% CI: 0.84–0.98) and hip fractures (HR 0.80; 95% CI: 0.71–0.91), but no reduction in all fractures (HR 0.95; 95% CI: 0.89–1.02).5 The pooled HR for the secondary outcome of all-cause mortality was not significant at 1.04 (95% CI: 0.95–1.14). The number needed to screen to prevent one fracture was 247 for osteoporotic fractures and 272 for hip fractures.5 This suggested that population screening might be effective in reducing osteoporotic fractures and hip fractures. Of the three recent RCTs using FRAX®,2–4 only the SCOOP study has published a cost-effectiveness analysis, which found that a widespread community-based screening program of fracture risk in older UK woman was likely to be cost-effective.15 Widespread applicability to the Australian population remains to be determined, mainly due to the lack of an Australian-specific treatment threshold above which bone-protective pharmacotherapy should be commenced. However, a population fracture risk screening program based around the FRAX® tool and DXA appears promising.16

  1. An initial FRAX® assessment, which provides the 10-year probability of MOF (clinical spine, hip, forearm or humerus) and/or hip fracture, can be used to risk stratify patients.
  2. Consider, particularly in older people, drug treatment in those with a prior and/or recent fragility fracture, with fracture risk assessment informing the choice of drug treatment, particularly the need for bone anabolic therapy.
  3. When BMD is included in a FRAX® assessment, the patient’s risk (high, very high or low) is determined by the higher of the two (MOF and hip fracture) risk assessments. (Note: ‘High’ is MOF risk ≥20% and hip risk ≥3%; ‘very high’ is MOF risk ≥30% and hip risk ≥4.5%.17)
  4. Men and women with low fracture risk and without a prior fragility fracture can be reassured their fracture risk is low and offered lifestyle advice, as appropriate.
  5. Consider referral of patients at very high risk to an endocrinologist or rheumatologist for assessment and consideration of parenteral treatment or first-line osteoanabolic drug treatment, especially those with multiple vertebral fractures. Indications for specialist referral may include a BMD T-score ≤–3.0 and one or more of the following:
    • treatment with glucocorticoids (refer promptly given rapid bone loss after initiation of glucocorticoids; if any delay is anticipated, start an oral bisphosphonate in the meantime)
    • the presence of multiple clinical risk factors, particularly with a recent fragility fracture indicating high imminent risk of refracture
    • other indicators of very high fracture risk (see Section 1.3).
  • Absolute fracture risk is not a qualifier for access to PBS-subsided therapy.
  • Estimation of absolute fracture risk using a fracture risk calculator does not consider lumbar spine BMD, and such estimates should not disqualify therapeutic decisions based on a low lumbar spine T-score.
  • Calculator-based estimations of fracture risk are estimates only, and should always be interpreted in the clinical, racial, and cultural context of the patient.
  • Strong shared decision making is important for treatment adherence given bone-protective treatment is long term and for risk management rather than symptom relief. Fracture risk assessment tools may be most useful for this reason.
  • When using the FRAX® tool (https://fraxplus.org), ensure to select ‘Calculation tool’ → ‘Oceania’ → ‘Australia’.
  1. Burden AM, Tanaka Y, Xu L, et al. Osteoporosis case ascertainment strategies in European and Asian countries: A comparative review. Osteoporos Int 2021;32(5):817–29.
  2. Shepstone L, Lenaghan E, Cooper C, et al. Screening in the community to reduce fractures in older women (SCOOP): A randomised controlled trial. Lancet 2018;391(10122):741–47.
  3. Rubin KH, Rothmann MJ, Holmberg T, et al. Effectiveness of a two-step population-based osteoporosis screening program using FRAX: The randomized Risk-stratified Osteoporosis Strategy Evaluation (ROSE) study. Osteoporos Int 2018;29(3):567–78.
  4. Merlijn T, Swart KM, van Schoor NM, et al. The effect of a screening and treatment program for the prevention of fractures in older women: A randomized pragmatic trial. J Bone Miner Res 2019;34(11):1993–2000.
  5. Merlijn T, Swart KMA, van der Horst HE, Netelenbos JC, Elders PJM. Fracture prevention by screening for high fracture risk: A systematic review and meta-analysis. Osteoporos Int 2020;31(2):251–57.
  6. McCloskey E, Kanis JA, Johansson H, et al. FRAX®-based assessment and intervention thresholds – an exploration of thresholds in women aged 50 years and older in the UK. Osteoporos Int 2015;26(8):2091-9.
  7. Kanis JA, McCloskey EV, Johansson H, Strom O, Borgstrom F, Oden A. Case finding for the management of osteoporosis with FRAX® – assessment and intervention thresholds for the UK. Osteoporos Int 2008;19(10):1395-1408.
  8. Dawson-Hughes B, Tosteson ANA, Melton LJ III, et al. Implications of absolute fracture risk assessment for osteoporosis practice guidelines in the USA. Osteoporos Int 2008;19(4):449-458.
  9. Tosteson ANA, Melton LJ, III, Dawson-Hughes B, et al. Cost-effective osteoporosis treatment thresholds: The United States perspective. Osteoporos Int 2008;19(4):437-447.
  10. Donaldson MG, Palermo L, Ensrud KE, Hochberg MC, Schousboe JT, Cummings SR. Effect of alendronate for reducing fracture by FRAX score and femoral neck bone mineral density: The Fracture Intervention Trial. J Bone Miner Res 2012;27(8):1804–10.
  11. Clark EM, Gould V, Morrison L, Ades AE, Dieppe P, Tobias JH. Randomized controlled trial of a primary care-based screening program to identify older women with prevalent osteoporotic vertebral fractures: Cohort for Skeletal Health in Bristol and Avon (COSHIBA). J Bone Miner Res 2012;27(3):664–71.
  12. Reid IR, Horne AM, Mihov B, et al. Fracture prevention with zoledronate in older women with osteopenia. N Engl J Med 2018;379(25):2407–16.
  13. Scottish Intercollegiate Guidelines Network (SIGN). Management of osteoporosis and the prevention of fragility fractures. SIGN, 2021 [Accessed 30 October 2023]
  14. Moriwaki K, Komaba H, Noto S, et al. Cost-effectiveness of alendronate for the treatment of osteopenic postmenopausal women in Japan. J Bone Miner Res 2013;28(2):395–403.
  15. Söreskog E, Borgström F, Shepstone L, et al. Long-term cost-effectiveness of screening for fracture risk in a UK primary care setting: The SCOOP study. Osteoporos Int 2020;31(8):1499–506.
  16. Nelson HD, Haney EM, Dana T, Bougatsos C, Chou R. Screening for osteoporosis: An update for the U.S. Preventive Services Task Force. Ann Intern Med 2010;153(2):99–111.
  17. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis – 2020 update. Endocr Pract 2020;26(Suppl 1):1–46.
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