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)

• Published in: Osteoporosis international Vol. 19; no. 4; pp. 493 - 501
• Main Authors: Cooper, C., Jakob, F., Chinn, C., Martin-Mola, E., Fardellone, P., Adami, S., Thalassinos, N. C., Melo-Gomes, J., Torgerson, D., Gibson, A., Marin, F.
• Format: Journal Article
• Language: English
• Published: London Springer-Verlag 01.04.2008; Springer; Springer Nature B.V
• Subjects: Adult; Aged; Biological and medical sciences; Bone Density - physiology; Bone Density Conservation Agents - administration & dosage; Bone Density Conservation Agents - adverse effects; Clinical outcomes; Diseases of the osteoarticular system; Drug therapy; Endocrinology; Female; Fractures; Fractures, Bone - prevention & control; Humans; Incidence; Injuries of the limb. Injuries of the spine; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Original Article; Orthopedics; Osteoporosis; Osteoporosis, Postmenopausal - physiopathology; Osteoporosis, Postmenopausal - therapy; Osteoporosis. Osteomalacia. Paget disease; Patient Compliance - statistics & numerical data; Quality of life; Quality of Life - psychology; Rheumatology; Surveys and Questionnaires; Traumas. Diseases due to physical agents; Treatment Failure; Women; Women's Health; EQ-5D; Osteoporosis; QUALEFFO; Fracture; Menopause; Quality of life; Human; Prognosis; Diseases of the osteoarticular system; Rheumatology; Fracture· Menopause· Osteoporosis· QUALEFFO; Epidemiology; Trauma; Incidence; Treatment; Woman
• ISSN: 0937-941X; 1433-2965
• DOI: 10.1007/s00198-007-0488-8

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.