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Fracture risk assessment without bone density measurement in routine clinical practice

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Abstract

Summary

Fracture probability assessed without bone mineral density (BMD) could potentially be sufficient for clinical decision making in many individuals categorized as low or high fracture risk. For individuals falling in a moderate risk range, there is incremental value in using BMD in the probability calculation as this appropriately reclassifies risk in over one third of the individuals.

Introduction

A new fracture risk assessment tool from the World Health Organization (FRAX®) estimates 10-year major osteoporotic and hip fracture probabilities from multiple clinical risk factors with or without hip BMD. The objective of this study is to determine whether fracture probability derived without BMD can be used to identify individuals who would be designated for treatment.

Methods

A historical cohort of 36,730 women and 2,873 men aged 50 years and older drawn from the Manitoba Bone Density Program database, which contains clinical BMD results for the Province of Manitoba, Canada, was included in the study.

Results

When 10-year probability for major osteoporotic fracture estimated without knowledge of BMD was high (≥20%), the vast majority (92.8%) qualified for intervention under the National Osteoporosis Foundation (NOF) guidelines, whereas among those at low risk (<10%), the vast majority (80.5%) did not satisfy any NOF intervention criteria. The benefit of including BMD in the risk assessment was greatest among those initially at moderate risk (10–19%) when fracture probability was derived without BMD, but this represented only 29.4% of the cohort (9.3% of those aged <65 years and 48.7% of those ≥65 years).

Conclusions

Fracture probability derived without BMD is able to risk stratify women in terms of future fracture risk and could potentially be sufficient for clinical decision making in many of those designated at low or high fracture risk.

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Acknowledgments

We are indebted to Manitoba Health for providing data (HIPC File No. 2007/2008-35). The results and conclusions are those of the authors, and no official endorsement by Manitoba Health is intended or should be inferred. This article has been reviewed and approved by the members of the Manitoba Bone Density Program Committee.

Conflicts of interest

William Leslie received unrestricted research grants from Merck Frosst, Amgen, and Genzyme and research honoraria and unrestricted educational grants from Sanofi-Aventis, Warner-Chilcott/Procter & Gamble, and Novartis. He is also a member of the advisory boards of Genzyme, Novartis, and Amgen. Lisa Lix received an unrestricted research grant from Amgen. Suzanne Morin is a consultant to Warner-Chilcott/Procter & Gamble, Sanofi-Aventis, Amgen, and Novartis. She is also a member of the speaker bureau of Amgen and Novartis. Eugene McCloskey received speaker fees and/or unrestricted research grants from Novartis, Amgen, AstraZeneca, Pfizer, Bayer, Warner-Chilcott/Procter & Gamble, Lilly, Roche, Servier, and Hologic. John A Kanis serves as director of the WHO Collaborating Centre for Metabolic Bone Diseases. Dr. Kanis led the team that developed FRAX; he has no financial interest in FRAX. Dr. Kanis has served as a consultant to Abiogen, Italy; Amgen, USA, Switzerland, and Belgium; Bayer, Germany; Besins-Iscovesco, France; Biosintetica, Brazil; Boehringer Ingelheim, UK; Celtrix, USA; D3A, France; the European Federation of Pharmaceutical Industries and Associations; Gador, Argentina; General Electric, USA; GSK, UK and USA; Hologic, Belgium and USA; Kissei, Japan; Leo Pharma, Denmark; Lilly, USA, Canada, Japan, Australia, and UK; Merck Research Labs, USA; Merlin Ventures, UK; MRL, China; Novartis, Switzerland and USA; Novo Nordisk, Denmark; Nycomed, Norway; Ono, UK and Japan; Organon, Holland; Parke-Davis, USA; Pfizer, USA; Pharmexa, Denmark; Procter and Gamble, UK and USA; ProStrakan, UK; Roche, Germany, Australia, Switzerland, and USA; Rotta Research, Italy; Sanofi-Aventis, USA; and Schering, Germany and Finland. He has provided expert testimony for the High Court (UK). His institution has received grants from the Medical Research Council (UK), the Arthritis and Rheumatism Council (UK), and the European Federation of Pharmaceutical Industries and Associations. He has received speaker’s fees from Amgen, Novartis, and Servier. He has also worked with the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, the Government of Manitoba, the Group for the Respect of Ethics and Excellence in Science, INSERM (France), the Medical Research Council (UK), the Ministry of Public Health of China, the Ministry of Health of Australia, the National Institute for Health and Clinical Excellence (UK), the National Osteoporosis Guideline Group (UK), the National Osteoporosis Society (UK), the International Osteoporosis Foundation, the Japanese Osteoporosis Society, Osteoporosis 2000 (UK), Osteoporosis Australia, the Swiss Osteoporosis Society, and the WHO. The other authors do not have any conflicts of interest to declare.

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Correspondence to W. D. Leslie.

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Supplementary Table 1

Area under the curve (AUC) for fracture prediction. (DOC 15.5 kb)

Supplementary Table 2

Proportion of individuals satisfying intervention criteria according to risk categorization from hip fracture probability without BMD. (DOC 39.5 kb)

Supplementary Fig. 1

Receiver operating characteristic curves for identification of individuals meeting intervention criteria using major osteoporotic fracture probability (dark) and hip fracture probability (light) calculated without BMD. (DOC 202 kb)

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Leslie, W.D., Morin, S., Lix, L.M. et al. Fracture risk assessment without bone density measurement in routine clinical practice. Osteoporos Int 23, 75–85 (2012). https://doi.org/10.1007/s00198-011-1747-2

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