Effects of teriparatide in postmenopausal women with osteoporosis pre-treated with bisphosphonates: 36-month results from the European Forsteo Observational Study

European Journal of Endocrinology

Volumn 166, Issue 1, 2012, Pages 87-97

  Jakob, F ^a   Oertel, H ^b   Langdahl, B ^c   Ljunggren, O ^d   Barrett, A ^e   Karras, D ^f   Walsh, J B ^g   Fahrleitner Pammer, A ^h   Rajzbaum, G ⁱ   Barker, C ^e   Lems, W F ^j   Marin, F ^e  

^a UNIVERSITY OF WÜRZBURG   (Germany)

^b Department of Medical Research ^*  (Germany)

^c AARHUS UNIVERSITY HOSPITAL   (Denmark)

^d UPPSALA UNIVERSITY   (Sweden)

^e ELI LILLY AND COMPANY   (United States)

^f Veterans Administration Hospital   (Greece)

^g TRINITY COLLEGE DUBLIN   (Ireland)

^h MEDICAL UNIVERSITY OF GRAZ   (Austria)

ⁱ SAINT JOSEPH HOSPITAL   (France)

^j VU UNIVERSITY MEDICAL CENTER   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; CALCIUM; PARATHYROID HORMONE[1-34]; VITAMIN D;

AGED; ARTICLE; BACKACHE; BODY MASS; BONE DENSITY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG WITHDRAWAL; FEMALE; FRACTURE; HUMAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; POSTMENOPAUSE OSTEOPOROSIS; PRIORITY JOURNAL; QUALITY OF LIFE; RISK REDUCTION; TREATMENT DURATION; VISUAL ANALOG SCALE;

AGED; BONE DENSITY CONSERVATION AGENTS; DIPHOSPHONATES; FEMALE; HUMANS; OSTEOPOROSIS, POSTMENOPAUSAL; PROSPECTIVE STUDIES; QUALITY OF LIFE; TERIPARATIDE; TREATMENT OUTCOME;

EID: 84055199643     PISSN: 08044643     EISSN: 1479683X     Source Type: Journal    
DOI: 10.1530/EJE-11-0740     Document Type: Article

References (46)

1. Lips P & van Schoor NM. Quality of life in patients with osteoporosis. Osteoporosis International 2005 16 447-455. (doi:10.1007/s00198- 004-1762-7)
2. Cooper C, Jakob F, Chinn C, Martin-Mola E, Fardellone P, Adami S, Thalassinos NC, Melo-Gomes J, Torgerson D, Gibson A & Marin F. Fracture incidence and changes in quality of life in women with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO). Osteoporosis International 2008 19 493-501. (doi:10.1007/s00198-007-0488-8)
3. Francis RM, Aspray TJ, Hide G, Sutcliffe AM & Wilkinson P. Back pain in osteoporotic vertebral fractures. Osteoporosis International 2008 19 895-903. (doi:10.1007/s00198-007-0530-x)
4. Kanis JA, Burlet N, Cooper C, Delams PD, Reginster J-Y, Borgstrom F, Rizzoli R & on behalf of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) . European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporosis International 2008 19 399-428. (doi:10.1007/s00198-008-0560-z)
5. Qaseem A, Snow V, Shekelle P, Hopkins R Jr, Forciea MA, Owens DK & for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians . Pharmacologic treatment of low bone density or osteoporosis to prevent fractures. A clinical practice guideline from the American College of Physicians. Annals of Internal Medicine 2008 149 404-415.
6. Body J-J, Bergmann P, Boonen S, Boutsen Y, Devogelaer J-P, Goemaere S, Kaufman J-M, Rozenberg S & Reginster J-Y. Evidence-based guidelines for the pharmacological treatment of postmenopausal osteoporosis: a consensus document by the Belgian Bone Club. Osteoporosis International 2010 21 1657-1680. (doi:10.1007/s00198-010-1223-4)
7. Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O & Mitlak BH. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. New England Journal of Medicine 2001 344 1434-1441. (doi:10.1056/NEJM200105103441904)
8. Kaufman JM, Orwoll E, Goemaere S, San Martin J, Hossain A, Dalsky GP, Lindsay R & Mitlak BH. Teriparatide effects on vertebral fractures and bone mineral density in men with osteoporosis: treatment and discontinuation of therapy. Osteoporosis International 2005 16 510-516. (doi:10.1007/s00198-004- 1713-3)
9. Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP & Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. New England Journal of Medicine 2007 357 2028-2039. (doi:10.1056/NEJMoa071408)
10. Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H &Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. New England Journal of Medicine 2003 349 1216-1226. (doi:10.1056/NEJMoa035725)
11. Ettinger B, San Martin J, Crans G & Pavo I. Differential effects of teriparatide on BMD after treatment with raloxifene or alendronate. Journal of Bone and Mineral Research 2004 19 745-751. (doi:10.1359/jbmr.040117)
12. Obermayer-Pietsch BM, Marin F, McCloskey EV, Hadji P, Farrerons J, Boonen S, Audran M, Barker C, Anastasilakis AD, Fraser WD & for the EUROFORS Investigators . Effects of two years of daily teriparatide treatment on BMD in postmenopausal women with severe osteoporosis with and without prior antiresorptive treatment. Journal of Bone and Mineral Research 2008 23 1591-1600. (doi:10.1359/jbmr.080506)
13. Boonen S, Marin F, Obermayer-Pietsch B, Simoes ME, Barker C, Glass EV, Hadji P, Lyritis G, Oertel H, Nickelsen T, McCloskey EV &for the EUROFORS Investigators . Effects of previous antiresorptive therapy on the bone mineral density response to two years of teriparatide treatment in postmenopausal women with osteoporosis. Journal of Clinical Endocrinology and Metabolism 2008 93 852-860. (doi:10.1210/jc.2007-0711)
14. Rajzbaum G, Jakob F, Karras D, Ljunggren O, Lems WF, Langdahl BL, Fahrleitner-Pammer A, Walsh JB, Gibson A, Tynan AJ & Marin F. Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting. Current Medical Research and Opinion 2008 24 377-384. (doi:10.1185/ 030079908X261087)
15. Silverman SL. From randomized controlled trials to observational studies. American Journal of Medicine 2009 122 114-120. (doi:10.1016/j.amjmed.2008.09. 030)
16. Dowd R, Recker RR & Heaney RP. Study subjects and ordinary patients. Osteoporosis International 2000 11 533-536. (doi:10.1007/s001980070097)
17. Langdahl BL, Rajzbaum G, Jakob F, Karras D, Ljunggren O, Lems WF, Fahrleitner-Pammer A, Walsh JB, Barker C, Kutahov A & Marin F. Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS). Calcified Tissue International 2009 85 484-493. (doi:10.1007/s00223-009-9299-6)
18. Fahrleitner-Pammer A, Langdahl BL, Marin F, Jakob F, Karras D, Barrett A, Ljunggren O, Walsh JB, Rajzbaum G, Barker C &Lems WF. Fracture rate and back pain during and after discontinuation of teriparatide: 36-month data from the European Forsteo Observational Study (EFOS). Osteoporosis International 2011 22 2709-2719 doi: 10.1007/s00198-010-1498-5. (doi:10.1007/s00198-010-1498-5)
19. Forsteo (teriparatide). Summary of Product Characteristics. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/ medicines/000425/human--med-000798.jsp&murl=menus/medicines/medicines. jsp&jsenabled=true. Accessed 25 March 2011.
20. Ross PD. Clinical consequences of vertebral fractures. American Journal of Medicine 1997 103 30S-42S. (doi:10.1016/S0002-9343(97)90025-5)
21. The EuroQol Group. EuroQoL - a new facility for the measurement of health-related quality of life. Health Policy 1990 16 199-208. (doi:10.1016/0168-8510(90)90421-9)
22. Szende A & Williams A. Measuring self reported population health: an international perspective based on EQ-5D. Budapest: SpringMed, 2004
23. Liang YK & Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika 1986 73 13-22. (doi:10.1093/biomet/73.1.13)
24. Hosmer DW & Lemeshow S. In Applied Logistic Regression, 2nd edn. New York: Wiley, 2000.
25. Lindsay R, Scheele WH, Neer R, Pohl G, Adami S, Mautalen C, Reginster J-Y, Stepan JJ, Myers SL & Mitlak BH. Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis. Archives of Internal Medicine 2004 164 2024-2030. (doi:10.1001/archinte.164.18.2024)
26. Prince R, Sipos A, Hossain A, Syversen U, Ish-Shalom S, Marcinowska E, Halse J, Lindsay R, Dalsky GP & Mitlak BH. Sustained nonvertebral fragility fracture risk reduction after discontinuation of teriparatide treatment. Journal of Bone and Mineral Research 2005 20 1507-1513. (doi:10.1359/JBMR.050501)
27. Abelson A, Ringe JD, Gold DT, Lange JL & Thomas T. Longitudinal change in clinical fracture incidence after initiation of bisphosphonates. Osteoporosis International 2010 21 1021-1029. (doi:10.1007/s00198-009-1046-3)
28. Lindsay R, Miller P, Pohl G, Glass EV, Chen P & Krege JH. Relationship between duration of teriparatide therapy and clinical outcomes in postmenopausal women with osteoporosis. Osteoporosis International 2009 20 943-948. (doi:10.1007/s00198-008-0766-0)
29. Chavassieux PM, Arlot ME, Reda C, Wei L, Yates AJ & Meunier PJ. Histomorphometric assessment of the long-term effects of alendronate on bone quality and remodeling in patients with osteoporosis. Journal of Clinical Investigation 1997 100 1475-1480. (doi:10.1172/JCI119668)
30. Eriksen EF, Melsen F, Sod E, Barton I & Chines A. Effects of long-term risedronate on bone quality and bone turnover in women with postmenopausal osteoporosis. Bone 2002 31 620-625. (doi:10.1016/S8756-3282(02) 00869-4)
31. Recker RR, Weinstein RS, Chesnut CH III, Schimmer RC, Mahoney P, Hughes C, Bonvoisin B & Meunier PJ. Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporosis International 2004 15 231-237. (doi:10.1007/s00198-003-1530-0)
32. Recker RR, Delmas PD, Halse J, Reid IR, Boonen S, Garcia-Hernandez PA, Supronik J, Lewiecki EM, Ochoa L, Miller P, Hu H, Mesenbrink P, Hartl F, Gasser J & Eriksen EF. Effects of intravenous zoledronic acid once yearly on bone remodeling and bone structure. Journal of Bone and Mineral Research 2008 23 6-16. (doi:10.1359/jbmr.070906)
33. Porras AG, Holland SD & Gertz BJ. Pharmacokinetics of alendronate. Clinical Pharmacokinetics 1999 36 315-328. (doi:10.2165/00003088-199936050- 00002)
34. Bone HG, Hosking D, Devogelaer JP, Tucci JR, Emkey RD, Tonino RP, Rodriguez-Portales JA, Downs RW, Gupta J, Santora AC, Liberman UA & Alendronate Phase III Osteoporosis Treatment Study Group . Ten years' experience with alendronate for osteoporosis in postmenopausal women. New England Journal of Medicine 2004 350 1189-1199. (doi:10.1056/NEJMoa030897)
35. Blumsohn A, Marin F, Nickelsen T, Brixen K, Sigurdsson G, GonzalezdelaVera J, Boonen S, Liu-Leage S, Barker C, Eastell R &EUROFORS Study Group . Early changes in biochemical markers of bone turnover and their relationship with bone mineral density changes after 24 months of treatment with teriparatide. Osteoporosis International 2011 22 1935-1946. (doi:10.1007/s00198-010-1379-y)
36. Stepan JJ, Burr DB, Li J, Ma YL, Petto H, Sipos A, Dobnig H, Fahrleitner-Pammer A, Michalska D & Pavo I. Histomorphometric changes by teriparatide in alendronate-pretreated women with osteoporosis. Osteoporosis International 2010 21 2027-2036. (doi:10.1007/s00198-009-1168-7)
37. Graeff C, Timm W, Nickelsen TN, Farrerons J, Marin F, Barker C, Gluer CC & for the EUROFORS High Resolution Computed Tomography Substudy Group . Monitoring teriparatide-associated changes in vertebral microstructure by high-resolution CT in vivo: results from the EUROFORS study. Journal of Bone and Mineral Research 2007 22 1426-1433. (doi:10.1359/jbmr.070603)
38. Graeff C, Chevalier Y, Charlebois M, Varga P, Pahr D, Nickelsen TN, Morlock MM, Gluer CC & Zysset PK. Improvements in vertebral body strength under teriparatide treatment assessed in vivo by finite element analysis: results from the EUROFORS study. Journal of Bone and Mineral Research 2009 24 1672-1680. (doi:10.1359/jbmr.090416)
39. Borggrefe J, Graeff C, Nickelsen TN, Marin F & Glüer CC. Quantitative computed tomographic assessment of the effects of 24 months of teriparatide treatment on 3D femoral neck bone distribution, geometry, and bone strength: results from the EUROFORS study. Journal of Bone and Mineral Research 2010 25 472-481. (doi:10.1359/jbmr.090820)
40. Middleton ET, Steel SA & Doherty SM. The effect of prior bisphosphonate exposure on the treatment response to teriparatide in clinical practice. Calcified Tissue International 2007 81 335-340. (doi:10.1007/s00223- 007-9066-5)
41. Keel C, Kraenzlin ME, Kraenzlin CA, Muller B & Meier C. Impact of bisphosphonate wash-out prior to teriparatide therapy in clinical practice. Journal of Bone and Mineral Metabolism 2010 28 68-76. (doi:10.1007/s00774-009- 0101-7)
42. Stepan JJ, Burr DB, Pavo I, Sipos A, Michalska D, Li J, Fahrleitner-Pammer A, Petto H, Westmore M, Michalsky D, Sato M &Dobnig H. Low bone mineral density is associated with bone microdamage accumulation in postmenopausal women with osteoporosis. Bone 2007 41 378-385. (doi:10.1016/j.bone.2007.04.198)
43. Dobnig H, Stepan JJ, Burr DB, Li J, Michalska D, Sipos A, Petto H, Fahrleitner-Pammer A & Pavo I. Teriparatide reduces bone microdamage accumulation in postmenopausal women previously treated with alendronate. Journal of Bone and Mineral Research 2009 24 1998-2006. (doi:10.1359/jbmr. 090527)
44. Chevalier Y, Quek E, Borah B, Gross G, Stewart J, Lang T & Zysset P. Biomechanical effects of teriparatide in women with osteoporosis treated previously with alendronate and risedronate: results from quantitative computed tomography-based finite element analysis of the vertebral body. Bone 2010 46 41-48. (doi:10.1016/j.bone.2009.09.032)
45. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM & de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine 2008 33 90-94. (doi:10.1097/BRS.0b013e31815e3a10)
46. Lyritis G, Marin F, Barker C, Pfeifer M, Farrerons J, Brixen K, del Pino J, Keen R, Nickelsen TN & EUROFORS Study Group. Back pain during different sequential treatment regimens of teriparatide: results from EUROFORS. Current Medical Research and Opinion 2010 26 1799-1807. (doi:10.1185/03007995.2010. 488516)