Abstract
ABSTRACTThe ability of the fracture risk assessment tool (FRAX) to discriminate between women who do and do not experience major osteoporotic fractures (MOFs) is suboptimal. Adding common clinical risk factors may improve discrimination. We used data from the Women's Health Initiative, a prospective study of women aged 50 to 79 years at baseline (n = 99,413; n = 5722 in BMD subset) enrolled at 40 US clinical centers. The primary outcome was incident MOFs assessed annually during 10 years' follow‐up. For prediction of incident MOF, we examined the area under the receiver operatic characteristic curve (AUC) and net reclassification index (NRI) of the FRAX model alone and FRAX plus additional risk factors (singly or together: type 2 diabetes mellitus, frequent falls [≥2 falls in the past year], vasomotor symptoms, self‐reported physical function score [RAND 36‐item Health Survey subscale), and lumbar spine BMD). For NRI calculations, high risk was defined as predicted MOF risk ≥20%. We also assessed calibration as observed MOF events/expected MOF events. The AUC value for FRAX without BMD information was 0.65 (95% CI, 0.65 to 0.66). Compared with the FRAX model (without BMD), the AUC value was not improved by the addition of vasomotor symptoms, diabetes, or frequent falls, but was minimally increased by adding physical function score (AUC 0.66, 95% CI, 0.66 to 0.67). FRAX was well‐calibrated for MOF prediction. The NRI of FRAX + additional variables versus FRAX alone was 5.7% (p < 0.001) among MOF cases and −1.7% among noncases (p > 0.99). Additional variables (diabetes, frequent falls, vasomotor symptoms, physical function score, or lumbar spine BMD) did not yield meaningful improvements in NRI or discrimination of FRAX for MOFs. Future studies should assess whether tools other than FRAX provide superior discrimination for prediction of MOFs. © 2019 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.
Highlights
The fracture risk assessment tool, FRAX, is a web-based clinical tool that uses individual clinical risk factors to predict the 10-year risk of hip fracture and the 10-year risk of major osteoporotic fracture (MOF; clinical spine, forearm, hip, or shoulder fracture).(1) The FRAX prediction tool can be used either with or without femoral neck BMD information
In the overall analytic sample, FRAX had suboptimal ability to distinguish between women who did and did not experience a MOF (AUC 0.65; 95% CI, 0.65 to 0.66)
Compared with the area under the receiver operating characteristic (AUC) value for FRAX alone in predicting a MOF, AUC values were not improved by the addition of vasomotor symptoms, diabetes, or frequent falls (≥2 falls in the past year), individually or simultaneously, to the FRAX model
Summary
The fracture risk assessment tool, FRAX, is a web-based clinical tool that uses individual clinical risk factors to predict the 10-year risk of hip fracture and the 10-year risk of major osteoporotic fracture (MOF; clinical spine, forearm, hip, or shoulder fracture).(1) The FRAX prediction tool can be used either with or without femoral neck BMD information. Because data were not consistently available in its development cohort, FRAX does not include several known fracture risk factors, such as type 2 diabetes[7,8,9] and falls.[9,10] FRAX is not validated for use with lumbar spine BMD.[1] If lumbar spine BMD is lower than femoral neck BMD, FRAX will underestimate major osteoporotic fracture risk.[11,12] In the National Health and Nutrition Examination Survey 2005 to 2008, roughly onethird of US women aged ≥50 years differed in skeletal status at the lumbar spine and hip, with most being normal at one site and having T-score ≤ −1.0 at the other site.[13] Women who are osteoporotic only at the spine may have not have been identified from hip BMD measurement alone, yet they may have high enough fracture risk to warrant consideration of treatment.[14] a previous report from the Women’s Health Initiative (WHI) study reported that women with vasomotor symptoms (hot flashes and/or night sweats) have lower BMD and higher fracture risk than women without vasomotor symptoms.[15,16]. Using data from the WHI, we examined measures of discrimination, calibration, and net risk reclassification to evaluate whether the addition of selected risk factors (frequent falls, type 2 diabetes mellitus, vasomotor symptoms, impaired physical function, and lumbar spine BMD) to FRAX improved model performance for prediction of risk of subsequent MOF
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