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  • Langdahl, Bente L. (author)

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)

  • E-article/E-chapterEnglish2016

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  • 2016

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  • LIBRIS-ID:20187407
  • http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-303024uri
  • urn:nbn:se:uu:diva-303024urn
  • 10.1007/s00223-016-0143-5doi

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  • Language:English

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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.

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  • Ljunggren, Östen (author)
  • Benhamou, Claude-Laurent (author)
  • Marin, Fernando (author)
  • Kapetanos, George (author)
  • Kocjan, Tomaz (author)
  • Lespessailles, Eric (author)
  • Napoli, Nicola (author)
  • Nikolic, Tatjana (author)
  • Petto, Helmut (author)
  • Moll, Thomas (author)
  • Lindh, Erik (author)
  • Uppsala universitetMedicinska och farmaceutiska vetenskapsområdet (publisher)

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  • Part of/supplement to:channel record
  • In:VärdpublikationCalcified Tissue International99:3, 259-2710171-967X

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