Abstract
Summary
This systematic review identified assessment guidelines for osteoporosis that incorporate FRAX. The rationale for intervention thresholds is given in a minority of papers. Intervention thresholds (fixed or age-dependent) need to be country-specific.
Introduction
In most assessment guidelines, treatment for osteoporosis is recommended in individuals with prior fragility fractures, especially fractures at spine and hip. However, for those without prior fractures, the intervention thresholds can be derived using different methods. The aim of this report was to undertake a systematic review of the available information on the use of FRAX® in assessment guidelines, in particular the setting of thresholds and their validation.
Methods
We identified 120 guidelines or academic papers that incorporated FRAX of which 38 provided no clear statement on how the fracture probabilities derived are to be used in decision-making in clinical practice. The remainder recommended a fixed intervention threshold (n = 58), most commonly as a component of more complex guidance (e.g. bone mineral density (BMD) thresholds) or an age-dependent threshold (n = 22). Two guidelines have adopted both age-dependent and fixed thresholds.
Results
Fixed probability thresholds have ranged from 4 to 20 % for a major fracture and 1.3–5 % for hip fracture. More than one half (39) of the 58 publications identified utilised a threshold probability of 20 % for a major osteoporotic fracture, many of which also mention a hip fracture probability of 3 % as an alternative intervention threshold. In nearly all instances, no rationale is provided other than that this was the threshold used by the National Osteoporosis Foundation of the USA. Where undertaken, fixed probability thresholds have been determined from tests of discrimination (Hong Kong), health economic assessment (USA, Switzerland), to match the prevalence of osteoporosis (China) or to align with pre-existing guidelines or reimbursement criteria (Japan, Poland). Age-dependent intervention thresholds, first developed by the National Osteoporosis Guideline Group (NOGG), are based on the rationale that if a woman with a prior fragility fracture is eligible for treatment, then, at any given age, a man or woman with the same fracture probability but in the absence of a previous fracture (i.e. at the ‘fracture threshold’) should also be eligible. Under current NOGG guidelines, based on age-dependent probability thresholds, inequalities in access to therapy arise especially at older ages (≥70 years) depending on the presence or absence of a prior fracture. An alternative threshold using a hybrid model reduces this disparity.
Conclusion
The use of FRAX (fixed or age-dependent thresholds) as the gateway to assessment identifies individuals at high risk more effectively than the use of BMD. However, the setting of intervention thresholds needs to be country-specific.
Abbreviations
- AACE:
-
American Association of Clinical Endocrinologists
- ACR:
-
American College of Rheumatology
- AUC:
-
Area under the receiver operating characteristic (ROC) curve
- BMD:
-
Bone mineral density
- BMI:
-
Body mass index
- CAROC:
-
Canadian Association of Radiologists and Osteoporosis Canada
- CI:
-
Confidence interval
- CRF:
-
Clinical risk factor
- DXA:
-
Dual-energy X-ray absorptiometry
- ECTS:
-
European Calcified Tissue Society
- EFPIA:
-
European Federation of Pharmaceutical Industry Associations
- ESCEO:
-
European Society for Clinical and Economic Aspects of Osteoporosis
- FRAX:
-
WHO fracture risk assessment tool.
- HF:
-
Hip fracture
- HSOO:
-
Hungarian Society for Osteoporosis and Osteoarthrology
- IOF:
-
International Osteoporosis Foundation
- ISCD:
-
International Society of Clinical Densitometry
- JSBMR:
-
Japanese Society for Bone and Mineral Research
- MOF:
-
Major osteoporotic fracture
- NCGC:
-
National Clinical Guideline Centre
- NCGC:
-
National Clinical Guideline Centre
- NICE:
-
National Institute for health and Clinical Excellence
- NNF:
-
Number Needed to FRAX
- NNS:
-
Number needed to scan
- NOF:
-
National Osteoporosis Foundation, US
- NOFSA:
-
National Osteoporosis Foundation of South Africa
- NOGG:
-
National Osteoporosis Guideline Group, UK
- NRI:
-
Net reclassification improvement (I)
- OST:
-
Osteoporosis Self-Assessment Tool
- OSTPRE:
-
Kuopio Osteoporosis Risk Factor and Prevention - study
- PSTF:
-
US Preventive Services Task Force
- QALY:
-
Quality-adjusted life year
- QALY:
-
Quality-adjusted life year
- QFracture:
-
A fracture risk assessment tool
- RCP:
-
Royal College of Physicians, London
- ROC:
-
Receiver operating characteristics
- SCOOP:
-
Screening of older women for prevention of fracture - study
- SCORE:
-
Simple Calculated Osteoporosis Risk Estimation Tool
- SD:
-
Standard deviation
- SIGN:
-
Scottish Intercollegiate Guidelines Network
- SIOMMMS:
-
Società Italiana dell'Osteoporosi, del Metabolismo Minerale e delle Malattie dello Scheletro
- TBS:
-
Trabecular bone score
- THIN:
-
The Health Improvement Network
- T-score:
-
The number of SD units that BMD differs from the young healthy reference population
- WHO:
-
World Health Organization
- YAM:
-
Young adult mean values for BMD
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Acknowledgments
We are grateful to the University of Southampton and the International Osteoporosis Foundation for their help with the literature searches. The manuscript was appraised by the members of the Committee of Scientific Advisors of the International Osteoporosis Foundation and the National Osteoporosis Guideline Group (UK) and we appreciate their constructive reviews. We are grateful to the International Osteoporosis Foundation and the National Osteoporosis Guideline Group for their endorsement of this paper.
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Conflicts of interest
Professor 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. Professors McCloskey, Oden, Harvey and Dr Johansson are members of the FRAX team. Professors Cooper, Kanis, Harvey and McCloskey are members of the Advisory Board of the National Osteoporosis Guideline Group. Ken E Poole, Neil Gittoes and Sally Hope declare no competing interests with respect to this paper.
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Additional information
Members of the Advisory Board of the National Osteoporosis Guideline Group: Cyrus Cooper, Nicholas Harvey, Eugene McCloskey, Ken E. Poole (Department of Medicine, University of Cambridge, Cambridge, UK); John A. Kanis, Neil Gittoes (Department of Endocrinology, University Hospitals Birmingham and University of Birmingham, Birmingham, UK); Sally Hope (Metabolic Bone Unit/Oxfordshire Osteoporosis Service, Nuffield Orthopaedic Centre, Oxford, UK).
Appendix
Appendix
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*Published after the cut-off date. Recommends an intervention threshold of 20 and 3 % probability of major and hip fracture, respectively.
Glossary
- Age-dependent threshold
-
Intervention or assessment threshold of fracture probability that varies with age
- Assessment threshold
-
The fracture probability at which further assessment id recommended (usually BMD)
- Fixed threshold
-
Intervention or assessment threshold of fracture probability that is fixed over all ages
- Fracture threshold
-
The average probability of fracture for a specific age
- Hybrid threshold
-
Intervention or assessment threshold of fracture probability that partly varies with age and is partly fixed
- Intervention threshold
-
For this report, the fracture probability at which treatment is recommended
- Major osteoporotic fracture
-
Fracture of hip, spine (clinical), distal forearm or humerus.
- NOGG strategy
-
The strategy that describes intervention or assessment threshold of fracture probability that varies with age
- Osteopenia
-
In this report, BMD defined: a T-score of between −1 and −2.5
- Osteoporosis
-
In this report, BMD defined: a T-score of <−2.5
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Kanis, J.A., Harvey, N.C., Cooper, C. et al. A systematic review of intervention thresholds based on FRAX. Arch Osteoporos 11, 25 (2016). https://doi.org/10.1007/s11657-016-0278-z
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DOI: https://doi.org/10.1007/s11657-016-0278-z