Osteoporosis International

, Volume 19, Issue 9, pp 1247–1250 | Cite as

Recommendations for the registration of agents for prevention and treatment of glucocorticoid-induced osteoporosis: an update from the Group for the Respect of Ethics and Excellence in Science

  • J. Compston
  • D. M. Reid
  • J. Boisdron
  • M.-L. Brandi
  • N. Burlet
  • D. Cahall
  • P. D. Delmas
  • W. Dere
  • J.-P. Devogelaer
  • L. A. Fitzpatrick
  • B. Flamion
  • N. Goel
  • S. Korte
  • A. Laslop
  • B. Mitlak
  • S. Ormarsdottir
  • J. Ringe
  • R. Rizzoli
  • Y. Tsouderos
  • T. Van Staa
  • J.-Y. Reginster
Consensus Statement
First Online:
Received:
Accepted:

Keywords

Bone mineral density Bridging study Glucocorticoid-induced osteoporosis Men Phase III studies Postmenopausal women 
This is a preview of subscription content, log in to check access.

Notes

Conflicts of interest

JC has received research grants from Servier and Procter & Gamble and advisory and/or speaking fees from Alliance for Better Bone Health, Amgen, Crescent Diagnostics, Eli Lilly, GlaxoSmith Kline, MSD, Nycomed, Novartis, Pfizer, Procter & Gamble, Roche, Servier and Wyeth. DMR has research grants from Roche, Amgen and Novartis and advisory and/or speaking fees from Amgen, GlaxoSmith Kline, Novartis, Pfizer, Procter & Gamble, Roche, Sanofi-Aventis, Servier and Wyeth. PD has research grants from Procter & Gamble, Eli Lilly and Amgen and advisory and/or speaking fees from Acceleron, Amgen, Eli Lilly, GlaxoSmith Kline, MSD, Novartis, Nycomed, Organon, Pfizer, Procter & Gamble, Roche, Sanofi-Aventis, Servier and Wyeth. JB is an employee of F. Hoffmann-La Roche Ltd. WD is employed by Amgen and is a shareholder in Amgen, Eli Lilly & Co, Merck and Pfizer. J-P D has research grants from Procter & Gamble, Eli Lilly and Novartis and advisory and/or speaking fees from Procter & Gamble, Aventis, Roche, Eli Lilly, Novartis and Servier. LF is an employee of GlaxoSmith Kline. NG is a full time employee of UCB Inc. and owns stock and stock options in UCB Inc. and Procter & Gamble. BM is an employee and shareholder of Eli Lilly & Co. SK is employed by Novartise Pharma AG. JR has received research grants from MSD, Procter & Gamble, Lilly, Servier, Novartis, Nycomed, Roche and GlaxoSmith Kline. RR has received advisory and/or speaking fees from the Alliance for Better Bone Health, Amgen, Danone, Eli Lilly, GlaxoSmith Kline MSD, Nycomed, Novartis, Roche, Servier and Wyeth. J-YR has received research grants from Bristol Myers, MSD, Rottapharm, Teva Lilly, Novartis, Roche, GlaxoSmith Kline, Amgen and Servier and advisory and/or speaking fees from Amgen Analis, Bristol Myers Squibb, Ebewee Pharma, Genevrier, GlaxoSmith~Kline IBSA, Lilly, MSD, Novaris, Nove-Nordisk, NPS, Nycomed, Roche, Rottapharm, Servier, Teijin, Teva, Theramex and Zodiac. MLB, AL, SO, JR, TVS have no conflict of interest.

References

  1. 1.
    van Staa TP, Leufkens HGM, Abenhaim L, Begaud B, Zhang B, Cooper C (2000) Use of oral corticosteroids in the United Kingdom. Q Med J 93:105–111Google Scholar
  2. 2.
    Canalis E, Bilezekian JP, Angeli A, Giustina A (2004) Perspectives on glucocorticoid-induced osteoporosis. Bone 34:593–598PubMedCrossRefGoogle Scholar
  3. 3.
    van Staa TP, Leufkens HGM, Cooper C (2002) A meta-analysis of the epidemiology of corticosteroid-induced osteoporosis. Osteoporos Int 13:777–787PubMedCrossRefGoogle Scholar
  4. 4.
    van staa TP, Leufkens HGM, Abenhaim L, Zhang B, Cooper C (2000) Oral corticosteroids and fracture risk: relationship to daily and cumulative doses. Rheumatol 39:1383–1389CrossRefGoogle Scholar
  5. 5.
    Van Staa T, Leufkens HGM, Abenhaim L, Zhang B, Cooper C (2000) Use of oral corticosteroids and risk of fractures. J Bone Miner Res 15:993–1000PubMedCrossRefGoogle Scholar
  6. 6.
    Laan RFJM, Van Riel PLCM, van de Putte LBA, van Erning LJTO, van’t Hof MA, Lemmens JAM (1993) Low-dose prednisone induces rapid reversible axial bone loss in patients with rheumatoid-arthritis - a randomized, controlled-study. Ann Intern Med 119:963–968PubMedGoogle Scholar
  7. 7.
    Kanis JA, Johansson H, Oden A et al (2004) A meta-analysis of prior corticosteroid use and fracture risk. J Bone Miner Res 19:893–899PubMedCrossRefGoogle Scholar
  8. 8.
    Luengo M, Picado C, Del Rio L, Guanabens N, Montserrat JM, Setoain J (1990) Treatment of steroid-induced osteopenia with calcitonin in corticosteroid-dependent asthma. Am Rev Resp Dis 142:104–107PubMedGoogle Scholar
  9. 9.
    van Staa TP, Laan RF, Barton IP, Cohen S, Reid DR, Cooper C (2003) Bone density threshold and other predictors of vertebral fracture in patients receiving oral glucocorticoid therapy. Arthritis Rheum 48:3224–3229PubMedCrossRefGoogle Scholar
  10. 10.
    Dalle Carbonare L, Arlot ME, Chavassieux PM, Roux JP, Portero NR, Meunier PJ (2001) Comparison of trabecular bone microarchitecture and remodeling in glucocorticoid-induced and postmenopausal osteoporosis. J Bone Miner Res 16:97–103PubMedCrossRefGoogle Scholar
  11. 11.
    Bresssot C, Meunier PJ, Chapuy MC et al (1979) Histomorphometric profile, pathophysiology and reversibility of corticosteroid-induced osteoporosis. Metab Bone Dis Rel Res 1:303–311CrossRefGoogle Scholar
  12. 12.
    Dempster DW (1989) Bone histomorphometry in glucocorticoid-induced osteoporosis. J Bone Miner Res 4:137–147PubMedCrossRefGoogle Scholar
  13. 13.
    Dempster DW, Arlot MA, Meunier PJ (1983) Mean wall thickness and formation periods of trabecular bone packets in corticosteroid-induced osteoporosis. Calcif Tissue Int 35:410–417PubMedCrossRefGoogle Scholar
  14. 14.
    Compston JE, Reginster J-Y, Avouac B et al (1996) Recommendations for the registration of agents used in the prevention and treatment of glucocorticoid-induced osteoporosis. Calcif Tissue Int 59:323–327PubMedCrossRefGoogle Scholar
  15. 15.
    Abadie EC, Devogelaer J-P, Ringe JD et al (2005) Recommendations for the registration of agents to be used in the prevention and treatment of glucocorticoid-induced osteoporosis: updated recommendations from the Group for the Respect of Ethics and Excellence in Science. Sem Arthritis Rheum 35:1–4CrossRefGoogle Scholar
  16. 16.
    Saag KG, Emkey R, Schnitzer TJ et al (1998) Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. New Engl J Med 339:292–299PubMedCrossRefGoogle Scholar
  17. 17.
    Cohen S, Levy RM, Keller M et al (1999) Risedronate therapy prevents corticosteroid-induced bone loss. Arthritis Rheum 42:2309–2318PubMedCrossRefGoogle Scholar
  18. 18.
    Reid DM, Hughes RA, Laan RFJM et al (2000) Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomised trial. J Bone Miner Res 15:1006–1013PubMedCrossRefGoogle Scholar
  19. 19.
    Orwoll ES, Ettinger M, Weiss S et al (2000) Alendronate for the treatment of osteoporosis in men. New Engl J Med 343:604–610PubMedCrossRefGoogle Scholar
  20. 20.
    Bobba R, Adachi JD (2007) Review of the safety and efficacy for the treatment of male osteoporosis. Clin Interv Aging 2:275–282PubMedGoogle Scholar
  21. 21.
    Orwoll ES, Scheele WH, Paul S et al (2003) The effect of teriparatide [human parathyroid hormone (1–34)] therapy on bone density in men with osteoporosis. J Bone Miner Res 18:9–17PubMedCrossRefGoogle Scholar

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2008

Authors and Affiliations

  • J. Compston
    • 1
  • D. M. Reid
    • 2
  • J. Boisdron
    • 3
  • M.-L. Brandi
    • 4
  • N. Burlet
    • 5
  • D. Cahall
    • 6
  • P. D. Delmas
    • 7
  • W. Dere
    • 8
  • J.-P. Devogelaer
    • 9
  • L. A. Fitzpatrick
    • 10
  • B. Flamion
    • 11
  • N. Goel
    • 12
  • S. Korte
    • 13
  • A. Laslop
    • 14
  • B. Mitlak
    • 15
  • S. Ormarsdottir
    • 16
  • J. Ringe
    • 17
  • R. Rizzoli
    • 18
  • Y. Tsouderos
    • 19
  • T. Van Staa
    • 20
  • J.-Y. Reginster
    • 21
  1. 1.Department of MedicineUniversity of Cambridge School of Clinical MedicineCambridgeUK
  2. 2.University of Aberdeen Medical SchoolAberdeenUK
  3. 3.Hoffman-La Roche LtdBasleSwitzerland
  4. 4.Metabolic Bone Unit, Laboratory of Molecular Genetics, Department of Internal MedicineUniversity of FlorenceFlorenceItaly
  5. 5.International Osteoporosis FoundationNyonSwitzerland
  6. 6.Sanofi-AventisCincinnatiUSA
  7. 7.Department of MedicineUniversity of Lyon and INSERM Research Unit 831LyonFrance
  8. 8.AmgenThousand OaksUSA
  9. 9.The Arthritis UnitUniversité Catholique de LouvainBrusselsBelgium
  10. 10.Medicines Disease CenterGlaxoSmithKlineKing of PrussiaUSA
  11. 11.Laboratory of Physiology and PharmacologyUniversity of NamurNamurBelgium
  12. 12.Clinical Development, UCB Inc.SmyrnaUSA
  13. 13.Novartis PharmaAGSwitzerland
  14. 14.AGES PharmMedViennaAustria
  15. 15.Lilly Research LaboratoriesEli Lilly and CompanyIndianapolisUSA
  16. 16.Icelandic Medicines Control AgencySeltjarnarnesIceland
  17. 17.West German Osteoporosis Center (WOZ) and Med. Clinic 4 at Klinikum LeverkusenUniverity of CologneCologneGermany
  18. 18.Division of Bone Diseases, WHO Collaborating Centre for Osteoporosis Prevention, Department of Rehabilitation and GeriatricsGeneva University Hospitals and Faculty of MedicineGenevaSwitzerland
  19. 19.Institut de Recherches Internationales ServierCourbevoieFrance
  20. 20.General Practice Research DatabaseMedicines and Healthcare Products Regulatory AgencyLondonUK
  21. 21.Department of Public Health SciencesUniversity of Liège, Liège, Belgium, Chairman GREESLiègeBelgium

Personalised recommendations