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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)

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Abstract

Summary

In this observational study of women with an inadequate clinical outcome to osteoporosis therapy, those with a fracture at baseline were more likely to sustain an incident fracture and have a worse health-related quality of life than those without prior fracture.

Introduction

The Observational Study of Severe Osteoporosis (OSSO) was designed to assess the fracture incidence and health-related quality of life (HRQoL) in women with an inadequate clinical outcome to osteoporosis therapy.

Methods

Post-menopausal women (N = 1,885) with established osteoporosis and an inadequate clinical response to osteoporosis drug therapy defined as: a) a fragility fracture despite therapy for one year (index fracture, N = 988), or b) discontinued drug therapy due to adverse effects and/or non-compliance (N = 897), were assessed during one year for HRQoL using the EQ-5D and the QUALEFFO questionnaires.

Results

One hundred and sixty-six (8.8%) women had a total of 209 incident fractures (1,139 fractures/10,000 women-years). Women with an index fracture were more likely to sustain an incident fracture than those without prior fractures (hazard ratio 1.91; 95% CI: 1.37–2.66; p < 0.001). Co-morbidities or antidepressant use at baseline also increased the risk of incident fracture. Median total EQ-5D Health State Values and QUALEFFO scores were worse in women with an incident fracture regardless of index fracture status. The worst scores were reported in the EQ-5D sub-domains of self-care, usual activities and pain/discomfort.

Conclusions

Women with an inadequate response to osteoporosis therapy had a high rate of incident fracture which had an adverse impact on HRQoL.

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References

  1. Sambrook P, Cooper C (2006) Osteoporosis. Lancet 367:2010–2018

    Article  PubMed  CAS  Google Scholar 

  2. Cumming SR, Melton LJ III (2002) Epidemiology and outcomes of osteoporotic fractures. Lancet 359:1761–1767

    Article  Google Scholar 

  3. Marcus R, Wong M, Heath H et al (2002) Antiresorptive treatment of postmenopausal osteoporosis: comparison of study designs and outcomes in large clinical trials with fracture as an endpoint. Endocr Rev 23:1535–1541

    Article  Google Scholar 

  4. Black DM, Thompson DE, Bauer DC et al, for the Fit Research Group (2000) Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. J Clin Endocrinol Metab 85:4118–4124

    Article  PubMed  CAS  Google Scholar 

  5. Maricic M, Adachi JD, Sarkar S et al (2002) Early effects of raloxifene on clinical vertebral fractures at 12 months in postmenopausal women with osteoporosis. Arch Intern Med 162:1140–1143

    Article  PubMed  CAS  Google Scholar 

  6. Harris ST, Watts NB, Genant HK et al (1999) Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomised control trial. JAMA 282:1344–1352

    Article  PubMed  CAS  Google Scholar 

  7. Black DM, Cummings SR, Karpf DB et al (1996) Randomised trial of the effect of alendronate on risk fracture in women existing vertebral fractures. Fracture Intervention Trial Research Group. Lancet 348:1535–1541

    Article  PubMed  CAS  Google Scholar 

  8. Ettinger B, Black DM, Mitlak BH et al (1999) Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomised clinical trial. JAMA 282:637–645

    Article  PubMed  CAS  Google Scholar 

  9. Chesnut CH, Silverman S, Andriano K et al (2000) A randomised trial of nasal spray calcitonin in postmenopusal women with established osteoporosis: the Prevent Recurrence of Osteoporotic Fractures Study. Am J Med 109:267–276

    Article  PubMed  CAS  Google Scholar 

  10. Neer RM, Arnaud CD, Zanchetta JR et al (2001) Effect of parathyroid hormone (1–34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 344:1434–1441

    Article  PubMed  CAS  Google Scholar 

  11. Meunier PJ, Roux C, Seeman E et al (2004) The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. N Engl J Med 350:459–468

    Article  PubMed  CAS  Google Scholar 

  12. Ettinger B, Pressman A, Schein J et al (1998) Alendronate use among 812 women: prevalence of gastrointestinal complaints, non-compliance with patient instructions, and discontinuation. J Manag Care Pharm 4:488–492

    Google Scholar 

  13. Hamilton B, McCoy K, Taggart H (2003) Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 14:259–262

    PubMed  CAS  Google Scholar 

  14. Solomon DH, Avorn J, Katz JN et al (2005) Compliance with osteoporosis medications. Arch Inter Med 165:2414–2419

    Article  Google Scholar 

  15. Turbi C, Herrero-Beaumont G, Acebes JC et al (2004) Compliance and satisfaction with raloxifene versus alendronate for the treatment of postmenopausal osteoporosis in clinical practice: an open-label, prospective, non-randomized, observational study. Clin Ther 26:245–256

    Article  PubMed  CAS  Google Scholar 

  16. Tosteson AN, Grove MR, Hammond CS et al (2003) Early discontinuation of treatment for osteoporosis. Am J Med 115:209–216

    Article  PubMed  Google Scholar 

  17. Badamgarav E, Fitzpatrick LA (2006) A new look at osteoporosis outcomes: the influence of treatment, compliance, persistence, and adherence. Mayo Clin Proc 81:1009–1012

    Article  PubMed  Google Scholar 

  18. NICE Guideline TA087. The clinical effectiveness and cost effectiveness of technologies for the secondary prevention of osteoporotic fractures in postmenopausal women. [http://www.nice.org.uk/page.aspx?o=115560]. Accessed: 08 March 2007

  19. Läkemedelsförmånsnämnden. Forsteo får fortsatt subvention med ny begränsning. [http://www.lfn.se/LFNTemplates/Ptjanst_1146.aspx]. Accessed: 08 March 2007

  20. Lems WF, Hamdy NAT, Netelenbos JC (2006) Teriparatide: an anabolic drug for the treatment of patients with osteoporosis. Ned Tijdschr Geneeskd 150:132–137

    PubMed  CAS  Google Scholar 

  21. Jakob F, Marin F, Martin-Mola E et al (2006) Characterization of patients with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO). Q J Med 99:531–543

    CAS  Google Scholar 

  22. Oleksik A, Lips P, Dawson A et al (2000) Health-related quality of life in postmenopausal women with low BMD with or without prevalent fractures. J Bone Miner Res 15:1384–1392

    Article  PubMed  CAS  Google Scholar 

  23. Lips P, Cooper C, Agnusdei D et al (1999) Quality of life in patients with vertebral fractures: validation of the quality of life questionnaire of the European Foundation for Osteoporosis (Qualeffo). Osteoporos Int 10:150–160

    Article  PubMed  CAS  Google Scholar 

  24. Oleksik AM, Ewing S, Shen W et al (2004) Impact of incident vertebral fractures on health-related quality of life (HRQoL) in post-menopausal women with prevalent vertebral fractures. Osteoporos Int 16:861–870

    Article  PubMed  Google Scholar 

  25. The EuroQol Group (1990) EuroQoL-a new facility for the measurement of health-related quality of life. Health Policy 16:199–208

    Article  Google Scholar 

  26. Marra CA, Woolcott JC, Kopec JA et al (2005) A comparison of generic, indirect utility measures (the HUI2, HUI3, SF-6D, and the EQ-5D) and disease-specific instruments (the RAQoL and the HAQ) in rheumatoid arthritis. Social Sci Med 60:1571–1582

    Article  Google Scholar 

  27. de Vries M, Ouwendijk R, Kessels AG et al (2005) Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease. J Vasc Surg 41:261–268

    Article  PubMed  Google Scholar 

  28. Wasserfallen J-B, Halabi G, Saudan P et al (2004) Quality of life on chronic dialysis: comparison between haemodialysis and peritoneal dialysis. Nephrol Dial Transplant 19:1594–1599

    Article  PubMed  Google Scholar 

  29. Hall SE, Criddle RA, Comito TL, Prince RL (1999) A case-control study of quality of life and functional impairment in women with long-standing vertebral osteoporotic fracture. Osteoporos Int 9:508–515

    Article  PubMed  CAS  Google Scholar 

  30. Fletcher A, Gore S, Jones D et al (1992) Quality of life measures in health care. II. Design, analysis and interpretation. BMJ 305:1145–1148

    PubMed  CAS  Google Scholar 

  31. Lips P, Cooper C, Agnusdei D et al (1997) Quality of life as outcome in the treatment of osteoporosis; the development of a questionnaire for quality of life by the European Foundation for osteoporosis. Osteoporos Int 7:36–38

    Article  PubMed  CAS  Google Scholar 

  32. Dolan P (1997) Modeling valuations for EuroQol health states. Med Care 35:1095–1108

    Article  PubMed  CAS  Google Scholar 

  33. Delmas PD, Seeman E (2004) Changes in bone mineral density explain little of the reduction in vertebral or nonvertebral fracture risk with anti-resorptive therapy. Bone 34:599–604

    Article  PubMed  CAS  Google Scholar 

  34. van Schoor NM, Smit JH, Twisk JWR, Lips P (2005) Impact of vertebral deformities, osteoarthritis, and other chronic diseases on quality of life: a population-based study. Osteoporos Int 16:749–756

    Article  PubMed  Google Scholar 

  35. Kanis JA, Johnell O, De Laet C et al (2004) A meta-analysis of previous fracture and subsequent fracture risk. Bone 35:375–382

    Article  PubMed  CAS  Google Scholar 

  36. Lindsay R, Silverman SL, Cooper C et al (2001) Risk of a new vertebral fracture in the year following a fracture. JAMA 285:320–323

    Article  PubMed  CAS  Google Scholar 

  37. Marin F, Tynan AJ, Mullarney T (2006) Study description and baseline characteristics of the population in the European Forsteo Observational Study (EFOS). Ann Rheum Dis 65(Suppl II):429

    Google Scholar 

  38. Lips P, van Schoor NM (2005) Quality of life in patients with osteoporosis. Osteoporos Int 16:447–455

    Article  PubMed  Google Scholar 

  39. Borgström F, Zethraeus N, Johnell O et al (2006) Costs and quality of life associated with osteoporosis-related fractures in Sweden. Osteoporos Int 17:637–650

    Article  PubMed  Google Scholar 

  40. Adachi JD, Ioannidis G, Olszynski WP et al (2002) The impact of incident vertebral and non-vertebral fractures on health related quality of life in postmenopausal women. BMC Musculoskeletal disorders 3:11

    Article  PubMed  Google Scholar 

  41. Martin AR, Sornay-Rendu E, Chandler JM et al (2002) The impact of osteoporosis on quality-of-life: the OFELY Cohort. Bone 31:2002–2032

    Article  Google Scholar 

  42. O’Neill TW, Cockerill W, Matthis C et al (2004) Back pain, disability, and radiographic vertebral fracture in European women: a prospective study. Osteoporos Int 15:760–765

    Article  PubMed  CAS  Google Scholar 

  43. Brooks R, Rabin R, de Charro F (2003) The measurement and valuation of health status using EQ-5D: a European perspective. Kluwer Academic Publishers, Dordrecht

    Google Scholar 

  44. Cockerill W, Lunt M, Siloman AJ et al (2004) Health-related quality of life and radiographic vertebral fracture. Osteoporos Int 15:113–119

    Article  PubMed  CAS  Google Scholar 

  45. Silverman SL, Minshall ME, Shen W et al, on behalf of the Health-Related Subgroup of the Multiple Outcomes of Raloxifene Evaluation Study (2001) The relationship of health related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis. Arthritis Rheum 44:2611–2619

    Article  PubMed  CAS  Google Scholar 

  46. Brazier JE, Green C, Kanis JA; Committee of Scientific Advisors International Osteoporosis Foundation (2002) A systematic review of health state utility values for osteoporosis-related conditions. Osteoporos Int 13:768–776

    Article  PubMed  CAS  Google Scholar 

  47. Honkanen K, Honkanen R, Heikkinen L, Kroger H, Saarikoski S (1999) Validity of self-reports of fractures in perimenopausal women. Am J Epidemiol 150:511–516

    PubMed  CAS  Google Scholar 

  48. Nevitt MC, Cummings SR, Browner WS et al (1992) The accuracy of self-report of fractures in elderly women: evidence from a prospective study. Am J Epidemiol 135:490–499

    PubMed  CAS  Google Scholar 

  49. Ismail AA, O’Neill TW, Cockerill W et al (2000) Validity of self-report of fractures: results from a prospective study in men and women across Europe. Osteoporos Int 11:248–254

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgements

The authors wish to thank Tracey Mullarney (Medical Statistics, Eli Lilly, Europe), Alexey Kutahov (Health Outcomes, Eli Lilly, Europe) and Cambridge Medical Writing Services, UK, for help in preparation of the manuscript. The OSSO study is funded by Eli Lilly and Company.

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Authors and Affiliations

  1. MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK

    C. Cooper

  2. Department of Orthopaedics, Julius-Maximilians-Universtität, Wurzburg, Germany

    F. Jakob

  3. Lilly Research Centre, Windlesham, UK

    C. Chinn, A. Gibson & F. Marin

  4. Servicio de Reumatologia, Hospital La Paz, Madrid, Spain

    E. Martin-Mola

  5. Service de Rhumatologie, Hopital Nord, Amiens, France

    P. Fardellone

  6. Centro Ospedaliero Clinicizzatodi Valeggio sul Mincio, Verona, Italy

    S. Adami

  7. Department of Endocrinology, Evangelismos General Hospital, Athens, Greece

    N. C. Thalassinos

  8. Instituto Portugues de Reumatologia, Lisbon, Portugal

    J. Melo-Gomes

  9. Department Health Sciences, University of York, York, UK

    D. Torgerson

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  1. C. Cooper
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  11. F. Marin
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Correspondence to C. Cooper.

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Cooper, C., Jakob, F., Chinn, C. et al. 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). Osteoporos Int 19, 493–501 (2008). https://doi.org/10.1007/s00198-007-0488-8

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  • DOI: https://doi.org/10.1007/s00198-007-0488-8

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