2 Research recommendations
The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of research recommendations is detailed in the full guideline.
What is the clinical and cost effectiveness of using GP practice lists to identify people at high risk of fracture, leading to formal risk assessment and possible treatment?
Fracture risk is currently assessed opportunistically. GP records are now universally computerised and contain information that may be useful in identifying patients at high risk of fracture (for example, age, record of prescriptions, major diagnoses and previous fracture). A study is needed to assess whether people at higher risk can be identified by using risk assessment tools to obtain an estimate of risk based on pre-existing information and inviting people at highest risk for a clinical assessment and risk-factor estimation. This could result in a more effective and efficient use of staff time and health service resources than an opportunistic approach.
What is the utility of FRAX and QFracture in adults receiving bone protective therapy?
Because of concerns about rare but serious side-effects of long-term anti-resorptive therapy, many physicians prescribe these drugs for a finite period of time, usually 3–5 years. Reassessment of fracture risk at the end of this treatment period is important, since some people remain at high risk of fracture and require continued treatment whereas others may benefit from a 'drug holiday' for 1 or more years. Neither FRAX nor QFracture has been examined in treated patients, and it is not known whether the ability of clinical risk factors with or without measurement of BMD to predict fracture risk is similar in untreated and treated patients. There is therefore a need for prospective studies to investigate the predictive power of these tools to assess fracture risk in patients after a period of bone protective therapy.
What is the utility of FRAX and QFracture in detecting risk of fragility fracture in adults with secondary causes of osteoporosis?
If secondary osteoporosis is entered as a risk factor in FRAX, the algorithm assumes that the effect is mediated solely through effects on BMD. Input of BMD into the questionnaire in such patients will therefore generate the same fracture risk whether or not secondary osteoporosis is entered. However, it is likely that at least some causes of secondary osteoporosis (for example, inflammatory bowel disease) affect fracture risk by mechanisms that are partially independent of BMD and fracture risk may therefore be underestimated in such patients. There is therefore a need to investigate the accuracy of FRAX in predicting fracture risk in patients with causes of secondary osteoporosis other than rheumatoid arthritis and to establish whether their effect on fracture risk is mediated solely through effects on BMD.
What is the added prognostic value of BMD in the assessment of fracture risk with FRAX?
The 10-year fracture risk as estimated by FRAX is calculated using clinical risk factors with or without BMD. The clinical risk factors are routinely available, making calculation of fracture risk possible at the time of consultation. However, refinement of a patient's 10-year fracture risk using BMD requires assessment using DXA scanning equipment.
Currently, there are no definitive studies in primary or secondary care evaluating whether the addition of BMD to FRAX improves the accuracy of the predicted fracture risk. There is a need for studies to examine whether adding BMD to FRAX results in the correct reclassification of patients from low risk to high risk (and vice-versa). Furthermore, studies are also needed to evaluate the clinical usefulness (net benefit) of adding BMD to FRAX; that is, how many more patients are correctly classified as high risk (true positives) and low risk (true negatives).
What is the utility of FRAX and QFracture in detecting risk of fragility fracture in adults living in residential care?
Care home residents are at high risk of fragility fracture. This is probably related to increased age and frailty with multiple comorbidities, which increase fracture risk. There is also evidence that care home residents have lower BMD, with 70% assessed as having osteoporosis using densitometry criteria alone. However, tools such as FRAX and QFracture, which only estimate fracture risk up to the 9th decade and use 10-year fracture risk, may underestimate short-term risk in care home residents, who have a mean age of approximately 85 years and a life expectancy of less than 5 years.
A study is required to assess whether care home residents should have targeted fracture risk assessment and whether residents at higher risk of fracture can be identified, using FRAX or QFracture. This could result in a more effective and efficient strategy for fracture prevention, targeting health service resources on those at the very highest fracture risk.