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Open Access Research article

Effective osteoporosis treatment with teriparatide is associated with enhanced quality of life in postmenopausal women with osteoporosis: the European Forsteo Observational Study

Östen Ljunggren1*, Annabel Barrett2, Ivaylo Stoykov2, Bente L Langdahl3, Willem F Lems4, J Bernard Walsh5, Astrid Fahrleitner-Pammer6, Gerald Rajzbaum7, Franz Jakob8, Dimitrios Karras9 and Fernando Marin2

Author Affiliations

1 Division of Endocrinology, Department of Medical Sciences, Uppsala University Hospital, Uppsala S-751 85, Sweden

2 Lilly Research Centre, Windlesham, UK

3 Aarhus University Hospital, Aarhus, Denmark

4 VU University Medical Centre, Amsterdam, The Netherlands

5 Trinity College, Dublin, Ireland

6 Medical University, Graz, Austria

7 Hôpital St. Joseph, Paris, France

8 Julius-Maximilians-Universitaet, Wuerzburg, Germany

9 Veterans Administration Hospital, Athens, Greece

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BMC Musculoskeletal Disorders 2013, 14:251  doi:10.1186/1471-2474-14-251

Published: 22 August 2013

Abstract

Background

To describe changes in health-related quality of life (HRQoL) of postmenopausal women with osteoporosis treated with teriparatide for up to 18 months and followed-up for a further 18 months, and to assess the influence of recent prior and incident fractures.

Methods

The European Forsteo Observational Study (EFOS) is an observational, prospective, multinational study measuring HRQoL using the EQ-5D. The primary objective was to assess changes in HRQoL during 36 months in the whole study population. A secondary post-hoc analysis examined fracture impact on HRQoL in four subgroups classified based on recent prior fracture 12 months before baseline and incident clinical fractures during the study. Changes from baseline were analysed using a repeated measures model.

Results

Of the 1581 patients, 48.4% had a recent prior fracture and 15.6% of these patients had an incident fracture during follow-up. 10.9% of the 816 patients with no recent prior fracture had an incident fracture. Baseline mean EQ-VAS scores were similar across the subgroups. In the total study cohort (n = 1581), HRQoL (EQ-VAS and EQ-5D index scores) improved significantly from baseline to 18 months and this improvement was maintained over the 18-month post-teriparatide period. Improvements were seen across all five EQ-5D domains during teriparatide treatment that were maintained after teriparatide was discontinued. Subjects with incident clinical fractures had significantly less improvement in EQ-VAS than those without incident fractures. Recent prior fracture did not influence the change in EQ-VAS during treatment.

Conclusions

EFOS is the first longitudinal study in women with severe postmenopausal osteoporosis in the real world setting to show a substantial improvement in HRQoL during teriparatide treatment that was sustained during subsequent treatment with other medications. The increase in HRQoL was lower in the subgroups with incident fracture but was not influenced by recent prior fracture. The results should be interpreted in the context of the design of an observational study.

Keywords:
EQ-5D; Fracture; Osteoporosis; Quality of life; Teriparatide