QJM Advance Access originally published online on July 22, 2006
QJM 2006 99(8):531-543; doi:10.1093/qjmed/hcl073
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Characterization of patients with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO)
From the 1Orthopaedic Department, Julius-Maximilians-Universität, Wurzburg, Germany, 2Lilly Research Center, Erl Wood Manor, Windlesham, UK, 3Servicio de Reumatología, Hospital La Paz, Madrid, Spain, 4Department Health Sciences, University of York, York, UK, 5Service de Rhumatologie, Hôpital Nord, Amiens, France, 6University of Verona, Centro Ospedaliero Clinicizzatodi Valeggio sul Mincio, Verona, Italy, 7Department of Endocrinology, Diabetes and Metabolism, Evangelismos General Hospital, Athens, Greece, 8Instituto Portugues de Reumatologia, Lisbon, Portugal and 9MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK
Address correspondence to Professor C. Cooper, MRC Epidemiology Resource Centre, University of Southampton, Southampton General Hospital, Southampton SO16 6YD. email: cc{at}mrc.soton.ac.uk
Received 14 March 2006 and in revised form 5 May 2006
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.