Abstract
Summary
Guidelines concerning the definition of failure of therapies used to reduce the risk of fracture are provided.
Introduction
This study aims to provide guidelines concerning the definition of failure of therapies used to reduce the risk of fracture.
Methods
A working group of the Committee of Scientific Advisors of the International Osteoporosis Foundation was convened to define outcome variables that may assist clinicians in decision making.
Results
In the face of limited evidence, failure of treatment may be inferred when two or more incident fractures have occurred during treatment, when serial measurements of bone remodelling markers are not suppressed by anti-resorptive therapy and where bone mineral density continues to decrease.
Conclusion
The provision of pragmatic criteria to define failure to respond to treatment provides an unmet clinical need and may stimulate research into an important issue.
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Acknowledgments
This working group has been funded by the International Osteoporosis Foundation.
Conflicts of interest
A. Diez-Perez has given lectures and provided advice for Novartis, Amgen, Lilly and MSD. His institution has received research grants from Amgen and Servier.
J.D. Adachi has given lectures and is a consultant for Amgen, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Procter & Gamble, Roche, Sanofi-Aventis, Warner Chilcott. D. Agnusdei is an employee of Eli Lilly.
J. Bilezikian is a consultant for Amgen, Merck, Lilly and GlaxoSmithKline, gives lectures for Amgen, Lilly and has received research grant from Amgen.
J. Compston has no disclosure.
S. Cummings is a consultant for Merck, Amgen and Lilly.
R. Eastell serves as a consultant, has received honoraria for speaking, and has received grant support from Amgen, AstraZeneca, California Pacific Medical Center, GlaxoSmithKline, Hologic, Kyphon Inc., Lilly Industries, Maxygen, Nastech Pharmaceuticals, Nestle Research Center, New Zealand Milk Limited, Novartis, Novo Nordisk, ONO-Pharma, Organon Laboratories, Osteologix, Pfizer, Procter & Gamble Pharmaceuticals, Roche Diagnostics, Sanofi-Aventis, Servier, Shire, Tethys, Trans-Pharma Medical Limited, Unilever and Unipath.
E. Eriksen has given lectures and has provided advice for Novartis, Amgen, Eli Lilly and ISD.
J. González-Macías has given lectures and provided advice for Amgen, Lilly, Servier and MSD.
U. Liberman has given lectures for MSD.
D Wahl declares no conflict of interest.
E. Seeman serves as advisory board member and gives lectures at symposia organised by several pharmaceutical companies including, variously Amgen, Warner Chilcott, MSD, Eli Lilly, Sanofi-Aventis, and Novartis.
J.A. Kanis receives research funding and consults with many companies involved with skeletal metabolism.
C. Cooper has received honoraria and consulting fees from Servier, Amgen, Eli Lilly, Merck, Medtronic and Novartis.
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This position paper has been endorsed by the Committee of Scientific Advisors of IOF.
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Diez-Perez, A., Adachi, J.D., Agnusdei, D. et al. Treatment failure in osteoporosis. Osteoporos Int 23, 2769–2774 (2012). https://doi.org/10.1007/s00198-012-2093-8
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DOI: https://doi.org/10.1007/s00198-012-2093-8