Osteoporosis: assessing the risk of fragility fracture

Intervention thresholds. A key concern from topic experts is the lack of clarity about thresholds for treatment which poses a problem in clinical practice. Although the original scope for osteoporosis: assessing the risk of fragility fracture (CG146) did not cover thresholds for intervention, other pieces of NICE guidance do cite thresholds, which differ as they were developed using different methods. In the NICE quality standard on osteoporosis (QS149), intervention thresholds were adapted from the National Osteoporosis Guideline Group's Clinical guideline for the prevention and treatment of osteoporosis which, in turn, are derived from FRAX (for details see quality statement 2). Until July 2019, the NICE technology appraisal on bisphosphonates for treating osteoporosis (TA464) included intervention thresholds which were determined from the levels of absolute fracture risk at which bisphosphonates were cost effective. In response to concerns raised by the MHRA that these thresholds included in TA464 may lead to wider use of bisphosphonates (oral and intravenous) in a population at low risk of fracture, outside of the supporting evidence, the recommendations were reviewed and amended. TA464 no longer includes information on the absolute risk level at which oral bisphosphonates are recommended and advises that bisphosphonates should be prescribed according to the recommendations in CG146 which defines who is eligible for osteoporotic fracture risk assessment, and QS149 which defines thresholds and the circumstances and preferences of individual people. See the review decision paper for full information. The NICE technology appraisals team are currently assessing non-bisphosphonates for treating osteoporosis (ID901) (expected publication date to be confirmed). Experts highlighted that a guideline definition of intervention thresholds with consideration of non-pharmacological interventions would be valued and would be the groundwork for consistency across NICE guidance. The emphasis from TA464 on applying the TA guidance in conjunction with the guideline and related quality standard emphasises the need for evidence-based thresholds to be determined within NICE guidelines.

Vertebral fractures. Vertebral fractures are one of the most common fragility fractures and are associated with decreased life expectancy. Topic expert feedback highlighted that the diagnosis and assessment of vertebral fractures are not addressed in CG146. It was also noted that although the two tools recommended in the guideline (FRAX and QFracture) assess the risk of fragility fracture, they may underestimate fracture risk in people with previous vertebral fracture(s). We identified a relevant ongoing study which aims to develop a checklist for use in primary care for identifying undiagnosed osteoporotic vertebral fractures in women with back pain (see ongoing research). Results are expected in June 2021 and we will pass the details of this study to the developers responsible for updating the guideline.

High-dose oral or high-dose systemic glucocorticoids is considered a major risk factor for fragility fractures. CG146 defines a high-dose of systemic glucocorticoid treatment as 7.5mg/day for 3 months, whereas QS149 defines a high-dose as 5mg/day for 3 months. There is no clear reason for this discrepancy, and this should be addressed in the update of CG146.

Bindex for investigating suspected osteoporosis (MIB106) provides advice for the use of Bindex for investigating suspected osteoporosis. This technology is not currently addressed in CG146 and could be considered in the update.

Using GP practice lists to identify people at high risk. New evidence suggests that community-based screening strategies might reduce the number of hip fractures in high risk populations.

FRAX and QFracture in adults receiving bone protective therapy. Topic experts agreed that the reassessment of fracture risk after 3–5 years of bisphosphonate treatment is not well considered in the current guideline. It was also noted that the NICE guideline on multimorbidity: clinical assessment and management (NG56) already recommends discussing whether bisphosphonate should be stopped after 3 years of treatment considering the benefits and harms of bisphosphonates, the risk of fracture, life expectancy and patient choice. Therefore, although no specific new evidence was identified, advice on risk assessment during bone protective treatment would be valued by the system.