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Fracture Rate, Qual...
Fracture Rate, Quality of Life and Back Pain in Patients with Osteoporosis Treated with Teriparatide 24-Month Results from the Extended Forsteo Observational Study (ExFOS)
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Langdahl, Bente L. (author)
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Ljunggren, Östen (author)
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Benhamou, Claude-Laurent (author)
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Marin, Fernando (author)
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Kapetanos, George (author)
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Kocjan, Tomaz (author)
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Lespessailles, Eric (author)
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Napoli, Nicola (author)
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Nikolic, Tatjana (author)
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Petto, Helmut (author)
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Moll, Thomas (author)
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Lindh, Erik (author)
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(publisher)
- 2016
- 2016
- English.
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In: Calcified Tissue International. - 0171-967X. ; 99:3, 259-271
Abstract
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- We describe the pre-planned interim analysis of fracture outcomes, health-related quality of life (HRQoL) and back pain in patients with severe osteoporosis treated with teriparatide for up to 24 months in the Extended Forsteo (Forsteo(A (R)) is a registered trade name of Eli Lilly and Company) Observational Study (ExFOS), a prospective, multinational, observational study. Data on incident clinical fractures, HRQoL (EQ-5D questionnaire) and back pain [100 mm visual analogue scale (VAS)] were collected. The number of patients with fractures was summarised in 6-month intervals and fracture rate over each 6-month period was assessed using logistic regression for repeated measures. Changes from baseline in EQ-5D and back pain VAS were analysed using mixed models for repeated measures. Of 1454 patients in the active treatment cohort, 90.6 % were female and 14.4 % were taking glucocorticoids. During teriparatide treatment (median duration 23.7 months), 103 patients (7.1 %) sustained a total of 122 incident clinical fractures (21 % vertebral, 79 % non-vertebral). A 49 % decrease in the odds of fractures and a 75 % decrease in the odds of clinical vertebral fractures were observed in the > 18- to 24-month period versus the first 6-month period (both p < 0.05). EQ-5D scores and back pain VAS scores were significantly improved from baseline at each post-baseline observation during teriparatide treatment. In conclusion, patients with severe osteoporosis showed a significant reduction in the incident fracture rate during 24 months of teriparatide treatment in routine clinical practice, accompanied by a significant improvement in HRQoL and reduction in back pain. Results should be interpreted in the context of the non-controlled design of this observational study.
Subject headings
- Medical and Health Sciences (hsv)
- Clinical Medicine (hsv)
- Endocrinology and Diabetes (hsv)
- Medicin och hälsovetenskap (hsv)
- Klinisk medicin (hsv)
- Endokrinologi och diabetes (hsv)
Keyword
- Osteoporosis
- Observational study
- Teriparatide
- Fractures
- Quality of life
- Back pain
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- By the author/editor
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Langdahl, Bente ...
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Ljunggren, Östen
-
Benhamou, Claude ...
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Marin, Fernando
-
Kapetanos, Georg ...
-
Kocjan, Tomaz
-
show more...
-
Lespessailles, E ...
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Napoli, Nicola
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Nikolic, Tatjana
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Petto, Helmut
-
Moll, Thomas
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Lindh, Erik
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show less...
- By the university
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