Treatment failure in osteoporosis
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Guidelines concerning the definition of failure of therapies used to reduce the risk of fracture are provided.
This study aims to provide guidelines concerning the definition of failure of therapies used to reduce the risk of fracture.
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.
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.
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.
KeywordsBone mineral density Fractures Markers of bone turnover Osteoporosis Treatment
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.
- 1.Food and Drug Administration (1994) Guidelines for preclinical and clinical evaluation of agents used in the prevention or treatment of postmenopausal osteoporosis. Division of Metabolism and Endocrine Drug Products, Food and Drug Administration, Rockville, MD, 1994Google Scholar
- 2.Committee for Medicinal Products for Human Use (CHMP) (2006) Guideline on the evaluation of medicinal products in the treatment of primary osteoporosis. Ref CPMP/EWP/552/95Rev.2. CHMP, London, Nov 2006Google Scholar
- 5.National Institute for Health and Clinical Excellence (2010) Final appraisal determination. Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women. NICE, LondonGoogle Scholar
- 6.National Institute for Health and Clinical Excellence (2010) Final appraisal determination. Alendronate, tidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. NICE, LondonGoogle Scholar
- 9.Ettinger B, Black DM, Mitlak BH (1999) Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomised clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 282:637–645PubMedCrossRefGoogle Scholar
- 24.Delmas PD, Li Z, Cooper C (2004) Relationship between changes in bone mineral density and fracture risk reduction with anti-resorptive drugs: some issues with meta-analyses. J Bone Miner Res 19:33–37Google Scholar
- 26.CRCPD’s Task Force on Bone Densitometry (2006) Technical White Paper: Bone Densitometry. October 2006. http://crcpd.org/Pubs/BoneDensitometryWhitePaper.pdf
- 27.El-Hajj Fulehian G, Testa MA, Angell JA, Porrino N, Leboff MS (1995) Reproducibility of DXA absorptiometry: a model for bone loss estimates. J Bone Miner Res 10:1004–1014Google Scholar
- 39.Vasikaran S, Eastell R, Bruyere O, for the IOF-IFCC Bone Marker Standards Working Group et al (2011) Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int 22:391–420PubMedCrossRefGoogle Scholar
- 45.Hadji P, Gamerdinger D, Spieler W et al (2012) Rapid Onset and Sustained Efficacy (ROSE) study: results of a randomised, multicentre trial comparing the effect of zoledronic acid or alendronate on bone metabolism in postmenopausal women with low bone mass. Osteoporos Int 23:625–633PubMedCrossRefGoogle Scholar