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Impact of incident vertebral fractures on health related quality of life (HRQOL) in postmenopausal women with prevalent vertebral fractures

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Abstract

Vertebral fractures are a common complication of osteoporosis and may cause a decrease of health-related quality of life (HRQOL). This study was designed to determine the impact of incident vertebral fractures on HRQOL. The Multiple Outcomes of Raloxifene Evaluation (MORE), a multicenter, randomized, double blind trial, in which women were taking raloxifene or placebo. This study was done in European centers only in a subset of 361 women from seven European countries, all with prevalent vertebral fractures. A specific questionnaire for osteoporosis developed by the International Osteoporosis Foundation was used for assessment at baseline, 1, 2 and 3 years. This questionnaire, Qualeffo, contains 41 questions in the domains pain, physical function, social function, general health perception and mental function. Domain and total scores are expressed on a 100-point scale with 0 corresponding to the best HRQOL. Standardized lateral spinal radiographs were made at baseline, 2 and 3 years and evaluated in a central facility. Sixty-seven patients sustained a fracture in a vertebra that was not fractured at baseline (incident vertebral fractures). Twenty of these were accompanied by signs and symptoms necessitating immediate doctor’s attention (clinical vertebral fractures) and 47 vertebral fractures were only diagnosed on radiographs (subclinical vertebral fractures). Incident vertebral fractures (clinical and subclinical) were associated with an increase of back pain (mean score change 6.4; 95% CI 2.1–10.7), deterioration of physical function (mean score change 2.4; 95% CI 0.1–4.8), and worse general health perception (mean score change 3.8; 95% CI 0.1–7.5). Score changes for patients with subclinical vertebral fractures were intermediate between those for patients with clinical vertebral fractures and patients without incident vertebral fracture. Clinical and subclinical incident vertebral fractures both have an adverse impact on HRQOL.

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Acknowledgements

We thank all investigators and study nurses involved in this project. We are grateful to Nicolette Pliester, Greetje Asma, Elisabeth Moseley, Sunny Xie, Michele Ennis and Emily Kenyon for data management. We thank Michael Minshall, Ronald Jansen, Alison Dawson and Tu Duong for advice on quality of life assessment and data analysis. Natasja van Schoor was supported by an unconditional grant from Wyeth. This study was funded by E. Lilly and Company. We also thank the Working Party for Quality of Life of the International Osteoporosis Foundation for comments and advice in the planning and reporting of this study. Members include D. Agnusdei (Siena), F. Caulin (Paris), C. Cooper, J. Kanis, A. Leplege (Paris), O. Johnell (Malmö), U.A. Liberman (Petah Tiqva), H Minne (Bad Pyrmont), J. Reeve (Cambridge), J.Y. Reginster (Liège), C. Todd (Cambridge), M.C. de Vernejoul (Paris) and I. Wiklund (Mölndal).

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Authors and Affiliations

  1. Department of Endocrinology, VU University Medical Center, Amsterdam, The Netherlands

    Anna M. Oleksik & Paul Lips

  2. Prevention Sciences Group, UCSF, San Francisco, Calif., USA

    Susan Ewing

  3. Eli Lilly & Co., Indianapolis, Ind., USA

    Wei Shen

  4. EMGO Institute, VU University Medical Center, PO Box 7057, 1007 MB, Amsterdam, The Netherlands

    Natasja M. van Schoor & Paul Lips

Authors
  1. Anna M. Oleksik
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  2. Susan Ewing
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  3. Wei Shen
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  4. Natasja M. van Schoor
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  5. Paul Lips
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Correspondence to Paul Lips.

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MORE Investigators Involved in QUALEFFO Project: Belgium: Thierry Appelboom, MD, Hospital Universitaire Erasme; Jean J. Body, MD, Institut Jules Bordet, Anne Peretz, MD, Hospital Universitaire Brugmann; and Jean P. Devogelaer, MD, Cliniques Universitaires Saint Luc, Brussels; Jan Dequeker, MD, Universitaire Ziekenhuis Pellenberg Lubbeek; Piet Geusens, MD, Limburgs Universitaire centrum Diepenbeek; Jean-Marck Kaufman, MD, Universitaire Ziekenhuis, Gent; and Jean-Yves Reginster, MD, Policliniques Universitaires L. Brull, Liege. France: Christian Alexandre, MD, CHU De St. Etienne Hospital Bellevue; Daniel Briancon, MD, Hospital Reine Hortense; Pierre Delmas, MD PhD, INSERM, Lyon; Patrice Fardellone, MD, CHU D’Amiens Hospital Sud; Jacques LeClere, MD, CHU De Nancy Hospital D’Adultes De Brabois; and Claude Ribot, MD, CHU De Toulouse Hospital De Rangueil. Germany: Elmar Keck, MD, Landesarztekammer Hessen, Wiesbaden; Peter Maier, MD, Staedt. Kurbetriebe Bad Waldsee; J. Semler and Christian Wuester, MD, Universitat Heidelberg. Italy: Maria Luisa Brandi, MD, PhD, Department of Clinical Physiopathology, Univerity of Florence; Pasquale Oriente, MD, Universita “Federico II,” Napoli; Carmelo Fiore, MD, Universita Di Catania; Andrea R. Genazzani, MD, Ospedale Santa Chiara Di Pisa; Carlo Gennari, MD, Institute of Internal Medicine, University of Siena; Giancarlo Isaia, MD, University of Torino; Gianfranco Mazzuoli, MD, Universita La Sapienza, Roma; Gian B. Melis, MD, Universita Di Cagliari; Torquato Nencioni, MD, Instituto Mangiagalli, Milano; Mario Passeri, MD, Universita Di Parma; and Leonardo Sartori, MD, PhD, Universita Di Padova. The Netherlands: Paul Lips, MD, PhD, Academic Hospital Vrije Universiteit, Amsterdam; Henk Mulder, MD, Medisch Onderzoekscentrum GCP, and Huibert A. Pols, MD, PhD, Erasmus University Medical Center, Rotterdam. Sweden: Karin Larsson, MD, Academic Hospital Uppsala; Dan Mellstrøm, MD, PhD, Göteborg University, Göteborg; Britt-Marie Nyhäll-Wåhlin, MD, and Mats Palmér, MD, Uppsala University, Orebro; Goran Toss, MD, Uppsala University, Linkoping. United Kingdom: Richard Eastell, BSc, MB, ChB, The Osteoporosis Center, University of Sheffield; Ignac Fogelman, BSc, MD, Guy’s Hospital, London; Robert Landray, MCCCHB, Synexus Ltd; David W. Purdie, MB, ChB, MD, The University of Hull, Centre for Metabolic Bone Disease; David M. Reid, MB, ChB, MD, University of Aberdeen; Ian Smith, BMS, MB, ChB, NHS Trust Royal Preston Hospital, Lancashire; Michael D. Stone, BA, MB, BS, Llandough Hospital, South Glamorgan.

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Oleksik, A.M., Ewing, S., Shen, W. et al. Impact of incident vertebral fractures on health related quality of life (HRQOL) in postmenopausal women with prevalent vertebral fractures. Osteoporos Int 16, 861–870 (2005). https://doi.org/10.1007/s00198-004-1774-3

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