Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)

Abstract Objective: To better characterize patients who are currently being prescribed teriparatide in Europe, this article describes the study design and baseline characteristics of participants of the Extended Forsteo* Observational Study (ExFOS). Research design and methods: ExFOS is a noninterve...

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Bibliographic Details
Published in:Current medical research and opinion 2014-08, Vol.30 (8), p.1607-1616
Main Authors: Ljunggren, Ö., Benhamou, C. L., Dekker, J., Kapetanos, G., Kocjan, T., Langdahl, B. L., Napoli, N., Petto, H., Nikoli, T., Lindh, E.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Back pain
Back Pain - epidemiology
Back Pain - etiology
Biological and medical sciences
Bone Density
Bone Density Conservation Agents - therapeutic use
Clinical Protocols
Diseases of the osteoarticular system
Diseases of the spine
Europe
Female
Follow-Up Studies
Fractures
Humans
Male
Medical sciences
Men
Middle Aged
Observational study
Osteoporosis
Osteoporosis - complications
Osteoporosis - drug therapy
Osteoporosis. Osteomalacia. Paget disease
Osteoporotic Fractures - epidemiology
Osteoporotic Fractures - etiology
Pharmacology. Drug treatments
Prospective Studies
Quality of Life
Research Design
Severity of Illness Index
Spinal Fractures - epidemiology
Spinal Fractures - etiology
Teriparatide
Teriparatide - therapeutic use
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Summary:Abstract Objective: To better characterize patients who are currently being prescribed teriparatide in Europe, this article describes the study design and baseline characteristics of participants of the Extended Forsteo* Observational Study (ExFOS). Research design and methods: ExFOS is a noninterventional, multicenter, prospective, observational study in men and women with osteoporosis treated with teriparatide during the course of normal clinical practice for up to 24 months and with a post-treatment follow-up of at least 18 months. Main outcome measures: Baseline characteristics, including history of fracture and back pain, and health-related quality of life (HRQoL, assessed using the EuroQol-5 Dimension [EQ-5D]). Results: Of 1607 patients enrolled, 90.9% were women. At baseline, mean (standard deviation [SD]) age was 70.3 (9.8) years, and 85.8% of patients had a history of fracture (64.7% with 2 fragility fractures). Of those with historic fractures, 90.8% had vertebral fractures (67.8% had thoracic fractures). The mean (SD) of reported bone mineral density T-scores were −3.0 (1.2), −2.4 (1.0), and −2.5 (0.9) for lumbar spine, total hip (left), and femoral neck (left), respectively. Overall, 39.3% of patients had experienced 1 fall during the 12 months before enrollment. At baseline, 11.4% of patients were osteoporosis-treatment naïve and 15% were currently using glucocorticoids. The mean (SD) visual analog scale score for back pain during the last month was 50.7 (26.9), and 62.1% of patients experienced daily or almost daily back pain. The median EQ-5D health state value at baseline was 0.62 (first and third quartiles: 0.19, 0.74). Conclusions: Baseline characteristics of the ExFOS study cohort indicate that patients prescribed teriparatide in Europe have severe osteoporosis with highly prevalent vertebral fractures, frequent and disabling back pain, and a poor HRQoL, despite previous pharmacotherapy for osteoporosis. Limitations include non-randomization, lack of a comparator group, and patient self-report for data on prior medication and fracture history.
ISSN:0300-7995
1473-4877
1473-4877
DOI:10.1185/03007995.2014.907561