J A Kanis1,2, H Johansson3,4, N C Harvey5,6, M Lorentzon3,7, E Liu3, L Vandenput3,8, E V McCloskey4,9. 1. Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia. w.j.pontefract@shef.ac.uk. 2. Centre for Metabolic Bone Diseases, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK. w.j.pontefract@shef.ac.uk. 3. Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia. 4. Centre for Metabolic Bone Diseases, University of Sheffield, Beech Hill Road, Sheffield, S10 2RX, UK. 5. MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK. 6. NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK. 7. Sahlgrenska Osteoporosis Centre, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden. 8. Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. 9. Mellanby Centre for Bone Research, Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.
Abstract
The National Osteoporosis Guideline Group (NOGG) has developed intervention thresholds based on FRAX® to characterise patients at high and very high risk of fracture. INTRODUCTION: Guidelines for the assessment of fracture risk have begun to categorise patients eligible for treatment into high and very high risk of fracture to inform choice of therapeutic approach. The aim of the present study was to develop intervention thresholds based on the hybrid assessment model of NOGG. METHODS: We examined the impact of intervention thresholds in a simulated cross-sectional cohort of women age 50 years or more from the UK with the distribution of baseline characteristics based on that in the FRAX cohorts. The prevalence of very high risk using the hybrid model was compared with age-dependent thresholds used by the International Osteoporosis Foundation and the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (IOF/ESCEO). The appropriateness of thresholds was tested based on the populations treated with anabolic agents. RESULTS: With an upper intervention threshold using the IOF/ESCEO criteria, 56% of women age 50 years or more would be characterised at very high risk. This compares with 36% using the IOF/ESCEO criteria and an age-specific intervention threshold over all ages. With an upper intervention threshold of 1.6 times the pre-existing intervention threshold, 10% of women age 50 years or more would be characterised at very high risk. The data from phase 3 studies indicate that most trial participants exposed to romosozumab or teriparatide would fall into the very high-risk category. CONCLUSIONS: Proposals for FRAX-based criteria for very high risk for the NOGG hybrid model categorise a small proportion of women age 50 years or more (10%) in this highest risk stratum. The level of risk identified was comparable to that of women enrolled in trials of anabolic agents.
The National Osteoporosis Guideline Group (NOGG) has developed intervention thresholds based on FRAX® to characterise patients at high and very high risk of fracture. INTRODUCTION: Guidelines for the assessment of fracture risk have begun to categorise patients eligible for treatment into high and very high risk of fracture to inform choice of therapeutic approach. The aim of the present study was to develop intervention thresholds based on the hybrid assessment model of NOGG. METHODS: We examined the impact of intervention thresholds in a simulated cross-sectional cohort of women age 50 years or more from the UK with the distribution of baseline characteristics based on that in the FRAX cohorts. The prevalence of very high risk using the hybrid model was compared with age-dependent thresholds used by the International Osteoporosis Foundation and the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (IOF/ESCEO). The appropriateness of thresholds was tested based on the populations treated with anabolic agents. RESULTS: With an upper intervention threshold using the IOF/ESCEO criteria, 56% of women age 50 years or more would be characterised at very high risk. This compares with 36% using the IOF/ESCEO criteria and an age-specific intervention threshold over all ages. With an upper intervention threshold of 1.6 times the pre-existing intervention threshold, 10% of women age 50 years or more would be characterised at very high risk. The data from phase 3 studies indicate that most trial participants exposed to romosozumab or teriparatide would fall into the very high-risk category. CONCLUSIONS: Proposals for FRAX-based criteria for very high risk for the NOGG hybrid model categorise a small proportion of women age 50 years or more (10%) in this highest risk stratum. The level of risk identified was comparable to that of women enrolled in trials of anabolic agents.
Authors: Celia L Gregson; David J Armstrong; Jean Bowden; Cyrus Cooper; John Edwards; Neil J L Gittoes; Nicholas Harvey; John Kanis; Sarah Leyland; Rebecca Low; Eugene McCloskey; Katie Moss; Jane Parker; Zoe Paskins; Kenneth Poole; David M Reid; Mike Stone; Julia Thomson; Nic Vine; Juliet Compston Journal: Arch Osteoporos Date: 2022-04-05 Impact factor: 2.879
Authors: Amit Gupta; Christina Maslen; Madhavi Vindlacheruvu; Richard L Abel; Pinaki Bhattacharya; Paul A Bromiley; Emma M Clark; Juliet E Compston; Nicola Crabtree; Jennifer S Gregory; Eleni P Kariki; Nicholas C Harvey; Eugene McCloskey; Kate A Ward; Kenneth E S Poole Journal: Ther Adv Musculoskelet Dis Date: 2022-03-28 Impact factor: 5.346
Authors: L Johansson; H Johansson; K F Axelsson; H Litsne; N C Harvey; E Liu; W D Leslie; L Vandenput; E McCloskey; J A Kanis; M Lorentzon Journal: Osteoporos Int Date: 2022-04-22 Impact factor: 5.071
Authors: Elizabeth M Curtis; Jean-Yves Reginster; Nasser Al-Daghri; Emmanuel Biver; Maria Luisa Brandi; Etienne Cavalier; Peyman Hadji; Philippe Halbout; Nicholas C Harvey; Mickaël Hiligsmann; M Kassim Javaid; John A Kanis; Jean-Marc Kaufman; Olivier Lamy; Radmila Matijevic; Adolfo Diez Perez; Régis Pierre Radermecker; Mário Miguel Rosa; Thierry Thomas; Friederike Thomasius; Mila Vlaskovska; René Rizzoli; Cyrus Cooper Journal: Aging Clin Exp Res Date: 2022-03-24 Impact factor: 4.481