Summary: Among 62,275 women and 6455 men, FRAX stratified risk for incident major osteoporotic fracture (MOF) and incident hip fracture (HF) without sex interaction. Performance was good in those with osteoporosis regardless of how this was defined. Introduction: Some studies have reported that FRAX performance differs according to sex and/or osteoporosis definitions. We evaluated whether the performance of FRAX to predict incident MOF and HF in women and men was affected by the presence or absence of osteoporosis defined by World Health Organization (WHO) or National Osteoporosis Foundation (NOF) criteria. Methods: We studied women and men age ≥ 40 years with baseline hip and spine DXA scans (1996–2013). Individuals were classified into four non-overlapping subgroups: osteoporosis by WHO criteria, osteoporosis exclusively by NOF criteria, high fracture risk by FRAX (MOF ≥ 20% or HF ≥ 3%, without osteoporosis), and low fracture risk (MOF OpenSPiltSPi 20% and HF OpenSPiltSPi 3% without osteoporosis). In each subgroup, we evaluated stratification (hazard ratios [HR]) and calibration (observed vs predicted 10-year fracture probability) for incident fracture. Results: The population included 62,275 women (5345 MOF and 1471 HF) and 6455 men (405 MOF and 108 HF). FRAX scores were strongly predictive of MOF (HR per SD: women 2.12, 95% CI 2.06–2.18; men 1.89, 95% CI 1.73–2.08; sex interaction p value = 0.97) and HF (women 4.78, 95% CI 4.44–5.14; men 4.20, 95% CI 3.22–5.49; sex interaction p value = 0.71). FRAX scores gave similar HRs for MOF among the four subgroups (subgroup interaction p value 0.34 for women, 0.22 for men). Observed versus predicted 10-year MOF and HF probability for the defined subgroups demonstrated a high level of concordance for women and men (all r 2 ≥ 0.9). Conclusions: FRAX was a strong and consistent predictor of MOF and HF in both women and men and performed well in those with osteoporosis whether defined by WHO or NOF criteria.
Bibliographical noteFunding Information:
John A. Kanis: Grants from Amgen, grants from Lilly, nonfinancial support from Medimaps, grants from Unigene, nonfinancial support from Asahi, and grants from Radius Health, outside the submitted work. Dr. Kanis is the architect of FRAX but has no financial interest. Governmental and NGOs: National Institute for health and clinical Excellence (NICE), UK; International Osteoporosis Foundation; INSERM, France; Ministry of Public Health, China; Ministry of Health, Australia; Ministry of Health, Abu Dhabi; National Osteoporosis Guideline Group, UK; WHO.
Funding information No funding support was received for this research project. SNM is chercheur-clinicienne boursier des Fonds de Recherche du Québec en Santé. LML is supported by a Manitoba Health Research Chair. SRM holds the Endowed Chair in Patient Health Management supported by the Faculties of Medicine and Dentistry and Pharmacy and Pharmaceutical Sciences at the University of Alberta.
Eugene McCloskey: Nothing to declare for FRAX and the context of this paper, but numerous ad hoc consultancies/speaking honoraria and/or research funding from Amgen, Bayer, General Electric, GSK, Hologic, Lilly, Merck Research Labs, Novartis, Novo Nordisk, Nycomed, Ono, Pfizer, ProStrakan, Roche, Sanofi-Aventis, Servier, Tethys, UBS, and Warner-Chilcott.
© 2018, International Osteoporosis Foundation and National Osteoporosis Foundation.
- Fracture risk assessment