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Study description a...
Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)
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- Ljunggren, Östen (author)
- Uppsala universitet,Endokrinologi och mineralmetabolism
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Benhamou, C. L. (author)
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Dekker, J. (author)
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Kapetanos, G. (author)
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Kocjan, T. (author)
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Langdahl, B. L. (author)
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Napoli, N. (author)
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Petto, H. (author)
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Nikolic, T. (author)
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Lindh, E. (author)
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(creator_code:org_t)
- 2014-05-02
- 2014
- English.
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 0300-7995 .- 1473-4877. ; 30:8, s. 1607-1616
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Keyword
- Back pain
- Fractures
- Men
- Observational study
- Osteoporosis
- Quality of life
- Teriparatide
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Ljunggren, Östen
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Benhamou, C. L.
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Dekker, J.
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Kapetanos, G.
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Kocjan, T.
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Langdahl, B. L.
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show more...
-
Napoli, N.
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Petto, H.
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Nikolic, T.
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Lindh, E.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
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Uppsala University