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Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Endocrinology and mineral metabolism.
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2014 (English)In: Current Medical Research and Opinion, ISSN 0300-7995, E-ISSN 1473-4877, Vol. 30, no 8, 1607-1616 p.Article in journal (Refereed) Published
Abstract [en]

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 naive 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.

Place, publisher, year, edition, pages
2014. Vol. 30, no 8, 1607-1616 p.
Keyword [en]
Back pain, Fractures, Men, Observational study, Osteoporosis, Quality of life, Teriparatide
National Category
Endocrinology and Diabetes
URN: urn:nbn:se:uu:diva-232009DOI: 10.1185/03007995.2014.907561ISI: 000340348100018OAI: oai:DiVA.org:uu-232009DiVA: diva2:746845
Available from: 2014-09-15 Created: 2014-09-12 Last updated: 2014-09-15Bibliographically approved

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Ljunggren, Östen
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