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QJM Advance Access published online on July 22, 2006
QJM, doi:10.1093/qjmed/hcl073
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© The Author 2006. Published by Oxford University Press on behalf of the Association of Physicians. All rights reserved. For Permissions, please email: Journals.permissions@oxfordjournals.org
Received March 14, 2006
Accepted May 5, 2006

Original Papers

Characterization of patients with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO)

F. Jakob 1, F. Marín 2, E. Martín-Mola 3, D. Torgerson 4, P. Fardellone 5, S. Adami 6, N.C. Thalassinos 7, D. Sykes 2, J. Melo-Gomes 8, C. Chinn 2, T. Nicholson 2, and C. Cooper 9 *

1 From the Orthopaedic Department, Julius-Maximilians-Universität, Wurzburg, Germany
2 From the Lilly Research Center, Erl Wood Manor, Windlesham, UK
3 From the Servicio de Reumatología, Hospital La Paz, Madrid, Spain
4 From the Department Health Sciences, University of York, York, UK
5 From the Service de Rhumatologie, Hôpital Nord, Amiens, France
6 From the University of Verona, Centro Ospedaliero Clinicizzatodi Valeggio sul Mincio, Verona, Italy
7 From the Department of Endocrinology, Diabetes and Metabolism, Evangelismos General Hospital, Athens, Greece
8 From the Instituto Portugues de Reumatologia, Lisbon, Portugal
9 From the MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK

* To whom correspondence should be addressed.
C. Cooper, E-mail: cc{at}mrc.soton.ac.uk


  Abstract

Background: Osteoporotic fractures remain a major public health problem. Currently available osteoporosis therapies significantly reduce the risk of fractures, but up to 50% of patients have an inadequate clinical outcome to therapy.

Aim: To describe the clinical and quality of life (QOL) of a study population meeting a proposed definition of inadequate clinical outcome to osteoporosis therapy, recruited for the Observational Study of Severe Osteoporosis (OSSO).

Design: Cross-sectional, observational study.

Methods: Post-menopausal women with osteoporosis (n = 2314) were divided into Group 1 (those who had previously experienced a fragility fracture despite osteoporosis drug therapy for at least 12 months) (n = 1309, 57%), or Group 2 (those who had previously discontinued osteoporosis drug therapy due to non-compliance or side-effects) (n = 1005; 43%). Baseline clinical characteristics, quality of life (QOL) and osteoporosis/falls risk factors were analysed.

Results: The overall population had low BMD (mean ± SD T-score at lumbar spine -3.1 ± 1.1), and risk factors for fracture such as previous fractures (67.8%), family history (15.1%), and prolonged glucocorticoid use (17.5%). QOL was poor: total QUALEFFO and EQ-5D scores were 46.8 ± 18.7, and 0.50 ± 0.33, respectively. Patients in Group 1 had higher age and body mass index, fewer hours of exercise, more previous fragility fractures and falls, and poorer QOL scores.

Discussion: Our definition of inadequate clinical outcome from osteoporosis drug therapy identifies a severe osteoporosis cohort with poor QOL and increased fracture risk. Using such a definition may lead to earlier recognition of inadequate clinical outcome to osteoporosis therapy, and improved interventions and results.


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