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The Impact of Regulatory and Scientific Organizations’ Recommendations on Clinical Decision-Making

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The Duration and Safety of Osteoporosis Treatment

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Abstract

Osteoporosis represents an increasingly significant healthcare challenge in a growing geriatric patient population. Regulatory bodies have developed guidelines for assessment and treatment of osteoporosis. Approaches to guideline development for osteoporosis have varied in terms of the use of systematic review methodology of evidence-grading systems and application of the Appraisal of Guidelines Research and Evaluation Framework (AGREE), resulting in different approaches and recommendations.

This chapter investigates a number of scientific national and international bodies’ recommendations on the duration of safety of osteoporosis therapies of anabolic and antiresorptive medications. Dosage recommendations, adverse events with a focus on atypical fractures and osteonecrosis of the jaw (ONJ), drug holiday recommendations, and supporting research evidence considered by these national and international bodies in decision-making are explored. Baseline risk and relative risk reduction considerations in evaluating varying treatment options are addressed as well.

The findings of this synthesis of evidence and recommendations support the importance of health professional awareness of adverse events associated with bisphosphonate utilization. Physicians must be aware of post-marketing data that can reflect and increase the number of patients exposed to osteoporosis medications. This exposure of osteoporosis medications in a frail elderly population is not included in clinical trials.

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Notes

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Authors and Affiliations

  1. Department of Medicine, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada

    Alexandra Papaioannou BScN, MD, MSc, FRCP(C), FACP & Sarah Karampatos BASc, MSc(c)

  2. Geriatric Education and Research in the Aging Sciences (GERAS) Centre, 88 Maplewood Avenue, Hamilton, ON, L8M 1W9, Canada

    Alexandra Papaioannou BScN, MD, MSc, FRCP(C), FACP & Sarah Karampatos BASc, MSc(c)

  3. Department of Biostatistics and Epidemiology, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada

    Alexandra Papaioannou BScN, MD, MSc, FRCP(C), FACP

  4. Faculty of Medicine, University of Toronto, Toronto, ON, Canada

    Arnav Agarwal BHSc

  5. Department of Rehabilitation Sciences, McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada

    Sarah Karampatos BASc, MSc(c)

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  1. Alexandra Papaioannou BScN, MD, MSc, FRCP(C), FACP
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  2. Arnav Agarwal BHSc
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  3. Sarah Karampatos BASc, MSc(c)
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Correspondence to Alexandra Papaioannou BScN, MD, MSc, FRCP(C), FACP .

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Editors and Affiliations

  1. Division of Rheumatology, Department of Medicine, Cedars-Sinai Medical Center; University of California Los Angeles, David Geffen School of Medicine, Los Angeles, California, USA

    Stuart Silverman

  2. Institute of Clinical Research; Department of Medicine, Holbæk, Denmark, University of Southern Denmark, Odense Patient Data Explorative Network; Holbæk Hospital, Odense, Denmark

    Bo Abrahamsen

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Papaioannou, A., Agarwal, A., Karampatos, S. (2016). The Impact of Regulatory and Scientific Organizations’ Recommendations on Clinical Decision-Making. In: Silverman, S., Abrahamsen, B. (eds) The Duration and Safety of Osteoporosis Treatment. Springer, Cham. https://doi.org/10.1007/978-3-319-23639-1_21

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  • DOI: https://doi.org/10.1007/978-3-319-23639-1_21

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