A systematic review of intervention thresholds based on FRAX

A report prepared for the National Osteoporosis Guideline Group and the International Osteoporosis Foundation

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.

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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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Correspondence to John A. Kanis.

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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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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

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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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Keywords

  • Assessment guidelines
  • Calibration
  • Discrimination
  • FRAX
  • Intervention threshold