Epidemiology; FRAX; Fracture probability; Hip fracture; Major osteoporotic fracture; Risk assessment; Endocrinology, Diabetes and Metabolism
Abstract :
[en] We describe the collection of cohorts together with the analysis plan for an update of the fracture risk prediction tool FRAX with respect to current and novel risk factors. The resource comprises 2,138,428 participants with a follow-up of approximately 20 million person-years and 116,117 documented incident major osteoporotic fractures.
INTRODUCTION: The availability of the fracture risk assessment tool FRAX® has substantially enhanced the targeting of treatment to those at high risk of fracture with FRAX now incorporated into more than 100 clinical osteoporosis guidelines worldwide. The aim of this study is to determine whether the current algorithms can be further optimised with respect to current and novel risk factors.
METHODS: A computerised literature search was performed in PubMed from inception until May 17, 2019, to identify eligible cohorts for updating the FRAX coefficients. Additionally, we searched the abstracts of conference proceedings of the American Society for Bone and Mineral Research, European Calcified Tissue Society and World Congress of Osteoporosis. Prospective cohort studies with data on baseline clinical risk factors and incident fractures were eligible.
RESULTS: Of the 836 records retrieved, 53 were selected for full-text assessment after screening on title and abstract. Twelve cohorts were deemed eligible and of these, 4 novel cohorts were identified. These cohorts, together with 60 previously identified cohorts, will provide the resource for constructing an updated version of FRAX comprising 2,138,428 participants with a follow-up of approximately 20 million person-years and 116,117 documented incident major osteoporotic fractures. For each known and candidate risk factor, multivariate hazard functions for hip fracture, major osteoporotic fracture and death will be tested using extended Poisson regression. Sex- and/or ethnicity-specific differences in the weights of the risk factors will be investigated. After meta-analyses of the cohort-specific beta coefficients for each risk factor, models comprising 10-year probability of hip and major osteoporotic fracture, with or without femoral neck bone mineral density, will be computed.
CONCLUSIONS: These assembled cohorts and described models will provide the framework for an updated FRAX tool enabling enhanced assessment of fracture risk (PROSPERO (CRD42021227266)).
Disciplines :
Public health, health care sciences & services
Author, co-author :
Vandenput, L ; Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia ; Sahlgrenska Osteoporosis Centre, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Johansson, H; Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia ; Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK
McCloskey, E V; Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK ; MRC Versus Arthritis Centre for Integrated Research in Musculoskeletal Ageing, Mellanby Centre for Musculoskeletal Research, University of Sheffield, Sheffield, UK
Liu, E; Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia
Åkesson, K E; Clinical and Molecular Osteoporosis Research Unit, Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Orthopedics, Skåne University Hospital, Malmö, Sweden
Anderson, F A; GLOW Coordinating Center, Center for Outcomes Research, University of Massachusetts Medical School, Worcester, MA, USA
Azagra, R; Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain ; Health Center Badia del Valles, Catalan Institute of Health, Barcelona, Spain ; GROIMAP (Research Group), Unitat de Suport a La Recerca Metropolitana Nord, Institut Universitari d'Investigació en Atenció Primària Jordi Gol, Santa Coloma de Gramenet, Barcelona, Spain
Bager, C L; Nordic Bioscience A/S, Herlev, Denmark
Beaudart, Charlotte ; Université de Liège - ULiège > Unité de recherche Santé publique, épidémiologie et économie de la santé (URSAPES)
Bischoff-Ferrari, H A; Department of Aging Medicine and Aging Research, University Hospital, Zurich, and University of Zurich, Zurich, Switzerland ; Centre On Aging and Mobility, University of Zurich and City Hospital, Zurich, Switzerland
Biver, E; Division of Bone Diseases, Department of Medicine, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland
Bruyère, Olivier ; Université de Liège - ULiège > Unité de recherche Santé publique, épidémiologie et économie de la santé (URSAPES)
Cauley, J A; Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Philadelphia, USA
Center, J R; Bone Biology, Healthy Ageing Theme, Garvan Institute of Medical Research, Sydney, NSW, Australia ; St Vincent's Clinical School, Faculty of Medicine, University of New South Wales Sydney, Sydney, NSW, Australia ; School of Medicine Sydney, University of Notre Dame Australia, Sydney, NSW, Australia
Chapurlat, R; INSERM UMR 1033, University of Lyon, Hôpital Edouard Herriot, Lyon, France
Cooper, Cyrus ; Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé ; MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK ; National Institute for Health Research Southampton Biomedical Research Centre, University of Southampton and University Hospitals Southampton NHS Foundation Trust, Southampton, UK ; National Institute for Health Research Oxford Biomedical Research Unit, , University of Oxford, Oxford, UK
Crandall, C J; Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine, University of California, Los Angeles, CA, USA
Cummings, S R; San Francisco Coordinating Center, California Pacific Medical Center Research Institute, San Francisco, CA, USA
da Silva, J A P; Coimbra Institute for Clinical and Biomedical Research, Faculty of Medicine, University of Coimbra, Coimbra, Portugal ; Rheumatology Department, University Hospital and University of Coimbra, Coimbra, Portugal
Dawson-Hughes, B; Bone Metabolism Laboratory, Jean Mayer US Department of Agriculture Human Nutrition Research Center On Aging, Tufts University, Boston, MA, USA
Diez-Perez, A; Department of Internal Medicine, Hospital del Mar and CIBERFES, Autonomous University of Barcelona, Barcelona, Spain
Dufour, A B; Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA, USA ; Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA
Eisman, J A; St Vincent's Clinical School, Faculty of Medicine, University of New South Wales Sydney, Sydney, NSW, Australia ; School of Medicine Sydney, University of Notre Dame Australia, Sydney, NSW, Australia ; Osteoporosis and Bone Biology Division, Garvan Institute of Medical Research, Sydney, NSW, Australia
Elders, P J M; Department of General Practice, Amsterdam UMC, Location VUmc, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
Ferrari, S; Division of Bone Diseases, Department of Medicine, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland
Fujita, Y; Department of Public Health, Faculty of Medicine, Kindai University, Osaka, Japan
Fujiwara, S; Department of Pharmacy, Yasuda Women's University, Hiroshima, Japan
Glüer, C-C; Section Biomedical Imaging, Molecular Imaging North Competence Center, Department of Radiology and Neuroradiology, University Medical Center Schleswig-Holstein Kiel, Kiel University, Kiel, Germany
Goldshtein, I; Maccabitech Institute of Research and Innovation, Maccabi Healthcare Services, Tel Aviv, Israel ; Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Goltzman, D; Department of Medicine, McGill University and McGill University Health Centre, Montreal, Canada
Gudnason, V; Icelandic Heart Association, Kopavogur, Iceland ; University of Iceland, Reykjavik, Iceland
Hall, J; MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK
HANS, Didier
Hoff, M; Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway ; Department of Rheumatology, St Olavs Hospital, Trondheim, Norway
Hollick, R J; Aberdeen Centre for Arthritis and Musculoskeletal Health, Epidemiology Group, University of Aberdeen, Aberdeen, UK
Huisman, M; Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, The Netherlands ; Department of Sociology, VU University, Amsterdam, The Netherlands
Iki, M; Department of Public Health, Faculty of Medicine, Kindai University, Osaka, Japan
Ish-Shalom, S; Endocrine Clinic, Elisha Hospital, Haifa, Israel
Jones, G; Menzies Institute for Medical Research, University of Tasmania, Hobart, Australia
Karlsson, M K; Clinical and Molecular Osteoporosis Research Unit, Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Orthopaedics, Skåne University Hospital, Malmö, Sweden
Khosla, S; Robert and Arlene Kogod Center On Aging and Division of Endocrinology, Mayo Clinic College of Medicine, Mayo Clinic, Rochester, MN, USA
Kiel, D P; Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, MA, USA ; Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA
Koh, W-P; Healthy Longevity Translational Research Programme, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore ; Singapore Institute for Clinical Sciences, Agency for Science Technology and Research (A*STAR), Singapore, Singapore
Koromani, F; Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands ; Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands
Kotowicz, M A; IMPACT (Institute for Mental and Physical Health and Clinical Translation), Deakin University, Geelong, VIC, Australia ; Barwon Health, Geelong, VIC, Australia ; Department of Medicine - Western Health, The University of Melbourne, St Albans, Victoria, Australia
Kröger, H; Department of Orthopedics and Traumatology, Kuopio University Hospital, Kuopio, Finland ; Kuopio Musculoskeletal Research Unit, University of Eastern Finland, Kuopio, Finland
Kwok, T; Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong ; Jockey Club Centre for Osteoporosis Care and Control, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong
Lamy, O; Centre of Bone Diseases, Lausanne University Hospital, Lausanne, Switzerland ; Service of Internal Medicine, Lausanne University Hospital, Lausanne, Switzerland
Langhammer, A; Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, HUNT Research Centre, Norwegian University of Science and Technology, Trondheim, Norway
Larijani, B; Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
Lippuner, K; Department of Osteoporosis, Bern University Hospital, University of Bern, Bern, Switzerland
Mellström, D; Geriatric Medicine, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden ; Geriatric Medicine, Sahlgrenska University Hospital Mölndal, Mölndal, Sweden
Merlijn, T; Department of General Practice, Amsterdam UMC, Location VUmc, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
Nordström, A; Division of Sustainable Health, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden ; School of Sport Sciences, Arctic University of Norway, Tromsø, Norway
Nordström, P; Unit of Geriatric Medicine, Department of Community Medicine and Rehabilitation, Umeå University, Umeå, Sweden
O'Neill, T W; National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK ; Centre for Epidemiology Versus Arthritis, University of Manchester, Manchester, UK
Obermayer-Pietsch, B; Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University Graz, Graz, Austria ; Center for Biomarker Research in Medicine, Graz, Austria
Ohlsson, C; Sahlgrenska Osteoporosis Centre, Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden ; Department of Drug Treatment, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden
Orwoll, E S; Department of Medicine, Oregon Health and Science University, Portland, OR, USA
Pasco, J A; Institute for Physical and Mental Health and Clinical Translation (IMPACT), Deakin University, Geelong, Australia ; Department of Medicine-Western Health, The University of Melbourne, St Albans, Australia ; Barwon Health, Geelong, Australia ; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia
Rivadeneira, F; Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands
Schei, B; Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway ; Department of Gynecology, St Olavs Hospital, Trondheim, Norway
Schott, A-M; Université Claude Bernard Lyon 1, U INSERM 1290 RESHAPE, Lyon, France
Shiroma, E J; Laboratory of Epidemiology and Population Sciences, National Institute On Aging, Baltimore, MD, USA
Simonsick, E M; Translational Gerontology Branch, National Institute On Aging Intramural Research Program, Baltimore, MD, USA
Sornay-Rendu, E; INSERM Research Unit 1033, Lyon, France
Sund, R; Kuopio Musculoskeletal Research Unit, University of Eastern Finland, Kuopio, Finland
Swart, K M A; Department of General Practice, Amsterdam UMC, Location VUmc, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
Szulc, P; INSERM UMR 1033, University of Lyon, Hôpital Edouard Herriot, Lyon, France
Tamaki, J; Department of Hygiene and Public Health, Faculty of Medicine, Educational Foundation of Osaka Medical and Pharmaceutical University, Osaka, Japan
Torgerson, D J; York Trials Unit, Department of Health Sciences, University of York, York, UK
van Schoor, N M; Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, The Netherlands
van Staa, T P; Centre for Health Informatics, Faculty of Biology, Medicine and Health, School of Health Sciences, University of Manchester, Manchester, UK
Vila, J; Statistics Support Unit, Hospital del Mar Medical Research Institute, CIBER Epidemiology and Public Health (CIBERESP), Barcelona, Spain
Wareham, N J; MRC Epidemiology Unit, University of Cambridge, Cambridge, UK
Wright, N C; Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL, USA
Yoshimura, N; Department of Preventive Medicine for Locomotive Organ Disorders, The University of Tokyo Hospital, Tokyo, Japan
Zillikens, M C; Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands
Zwart, M; Health Center Can Gibert del Plà, Catalan Institute of Health, Girona, Spain ; Department of Medical Sciences, University of Girona, Girona, Spain ; GROIMAP (Research Group), Institut Universitari d'Investigació en Atenció Primària Jordi Gol, Barcelona, Spain
Harvey, Nick ; Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé ; MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton, UK ; NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
Lorentzon, M; Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia ; Sahlgrenska Osteoporosis Centre, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden ; Geriatric Medicine, Region Västra Götaland, Sahlgrenska University Hospital, Mölndal, Sweden
Leslie, W D; Department of Medicine, University of Manitoba, Winnipeg, MB, Canada
Kanis, J A; Mary McKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia. w.j.pontefract@shef.ac.uk ; Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK. w.j.pontefract@shef.ac.uk ; Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, UK. w.j.pontefract@shef.ac.uk
JA Kanis led the team that developed FRAX as director of the WHO Collaborating Centre for Metabolic Bone Diseases; he has no financial interest in FRAX. EV McCloskey, WD Leslie, M Lorentzon, NC Harvey, E Liu, L Vandenput and H Johansson are members of the FRAX team. JA Kanis, NC Harvey and EV McCloskey are members of the advisory body to the National Osteoporosis Guideline Group. JA Kanis reports no additional competing interests. KE Åkesson has no financial interest related to FRAX; chaired the National SALAR Group for Person-Centered Care Pathway Osteoporosis. FA Anderson led the team that developed GLOW, while director of the Center for Outcomes Research at the University of Massachusetts Medical School; he has no financial interest in FRAX. R Azagra has received funding for research from Instituto Carlos III of Spanish Ministry of Health, IDIAP Jordi Gol of Catalan Government and from Scientific Societies SEMFYC and SEIOMM. CL Bager is employed at Nordic Bioscience and owns stock in Nordic Bioscience. She declares no competing interests in relation to this work. HA Bischoff-Ferrari has no financial interest in FRAX. For the DO-HEALTH trial cohort, Prof. Bischoff-Ferrari reports independent and investigator-initiated grants from European Commission Framework 7 Research Program, from the University of Zurich, from NESTEC, from Pfizer Consumer Healthcare, from Streuli Pharma, plus non-financial support from DNP. For the study cohort extension, she reports independent and investigator-initiated grants from Pfizer and from Vifor. Furthermore, Prof. Bischoff-Ferrari reports non-financial support from Roche Diagnostics and personal fees from Wild, Sandoz, Pfizer, Vifor, Mylan, Roche, Meda Pharma, outside the submitted work with regard to speaker fees and travel fees. JR Center has received honoraria for speaking at educational meetings and for advisory boards from Amgen and honoraria for an advisory board from Bayer. R Chapurlat has no financial interest in FRAX. He has received grant funding from Amgen, UCB, Chugai, MSD, Mylan and Medac. He has received honoraria from Amgen, UCB, Chugai, Galapagos, Biocon, Abbvie, Haoma Medica, Pfizer, Amolyt, MSD, Lilly, BMS, Novartis, Arrow, PKMed, Kyowa-Kirin and Sanofi. C Christiansen owns stock in Nordic Bioscience. He declares no competing interests in relation to this work. C Cooper reports personal fees from Alliance for Better Bone Health, Amgen, Eli Lilly, GSK, Medtronic, Merck, Novartis, Pfizer, Roche, Servier, Takeda and UCB. A Diez-Perez reports personal fees from Amgen, Lilly, Theramex and grants from Instituto Carlos III and owns shares of Active Life Scientific, all outside the submitted work. JA Eisman declares consulting and research support from Actavis, Amgen, Aspen, Lilly, Merck Sharp and Dohme, Novartis, Sanofi-Aventis, Servier and Theramex. PJM Elders has no financial interest in FRAX. PJM Elders reports support for the SOS study by Stichting Achmea Gezondheidszorg, Achmea and VGZ zorgverzekeraar. Additional support was given by the stichting Artsenlaboratorium en Trombosedienst. Outside the submitted work, she did receive independent investigator driven grants by Zonmw, the Netherlands, de Hartstichting, the Netherlands, the European foundation for the study of Diabetes, Amgen the Netherlands, TEVA, the Netherlands and Takeda, the Netherlands. NC Harvey has received consultancy/lecture fees/honoraria/grant funding from Alliance for Better Bone Health, Amgen, MSD, Eli Lilly, Radius Health, Servier, Shire, UCB, Consilient Healthcare and Internis Pharma. DP Kiel has no financial interest in FRAX but has received support for his work in the Framingham Study over the past 30 years by the National Institutes of Health, Astra Zeneca, Merck, Amgen and Radius Health. MA Kotowicz has received funding from the National Health and Medical Research Council (NHMRC) Australia, and the Medical Research Future Fund (MRFF) Australia. He has served on advisory boards for Amgen Australia, Novartic and Eli Lilly — all unrelated to this work and is the Director of the Geelong Bone Densitometry Service. M Lorentzon has received lecture fees from Amgen, Lilly, Meda, Renapharma and UCB Pharma and consulting fees from Amgen, Radius Health, UCB Pharma, Renapharma and Consilient Health, all outside the presented work. EV McCloskey has received consultancy/lecture fees/grant funding/honoraria from AgNovos, Amgen, AstraZeneca, Consilient Healthcare, Fresenius Kabi, Gilead, GSK, Hologic, Internis, Lilly, Merck, Novartis, Pfizer, Radius Health, Redx Oncology, Roche, Sanofi Aventis, UCB, ViiV, Warner Chilcott and I3 Innovus. C Ohlsson is listed as a coinventor on two patent applications regarding probiotics in osteoporosis treatment. ES Orwoll reports consulting fees from Amgen, Biocon, Radius and Bayer, and research support from Mereo. JA Pasco has received funding from the National Health and Medical Research Council (NHMRC) Australia, and the Medical Research Future Fund (MRFF) Australia, all unrelated to this work. MC Zillikens has received honoraria in the past for lectures or advice from Alexion, Amgen, Eli Lilly, Kyowa Kirin, Shire and UCB, unrelated to the current work. M Zwart has received research funding from national societies (SEMFYC and SEIOMM). C Beaudart, E Biver, O Bruyère, JA Cauley, CJ Crandall, SR Cummings, JAP da Silva, B Dawson-Huges, AB Dufour, S Ferrari, Y Fujita, S Fujiwara, C–C Glüer, I Goldshtein, D Goltzman, V Gudnason, J Hall, D Hans, M Hoff, RJ Hollick, M Huisman, M Iki, S Ish-Shalom, H Johansson, G Jones, MK Karlsson, S Khosla, W–P Koh, F Koromani, H Kröger, T Kwok, O Lamy, A Langhammer, B Larijani, WD Leslie, K Lippuner, E Liu, D Mellström, T Merlijn, A Nordström, P Nordström, TW O´Neill, B Obermayer-Pietsch, F Rivadeneira, B Schei, A-M Schott, EJ Shiroma, K Sigeirsdottir, EM Simonsick, E Sornay-Rendu, R Sund, KMA Swart, P Szulc, J Tamaki, DJ Torgerson, L Vandenput, NM van Schoor, TP van Staa, J Vila, NJ Wareham, NC Wright and N Yoshimura declare no competing interests in relation to this work.
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