| Author/Editor | Langdahl, Bente; Ljunggren, Östen; Benhamou, Claude; Marin, Fernando; Kapetanos, George; Kocjan, Tomaž; Lespessailles, Eric; Napoli, Nicola; Nikolic, Tatjana; Petto, Helmut | |
| Title | Fracture rate, quality of life and back pain in patients with osteoporosis treated with teriparatide | |
| Type | članek | |
| Vol. and No. | Letnik 99, št. 3 | |
| Publication year | 2016 | |
| Volume | str. 259-271 | |
| ISSN | 0171-967X - Calcified tissue international | |
| Language | eng | |
| Abstract | 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 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. | |
| Keywords | osteoporosis observational study quality of life osteoporoza opazovalna študija kakovost življenja |