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Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS)
This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeate...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153867/ https://www.ncbi.nlm.nih.gov/pubmed/29909449 http://dx.doi.org/10.1007/s00223-018-0437-x |
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author | Napoli, Nicola Langdahl, Bente. L. Ljunggren, Östen Lespessailles, Eric Kapetanos, George Kocjan, Tomaz Nikolic, Tatjana Eiken, Pia Petto, Helmut Moll, Thomas Lindh, Erik Marin, Fernando |
author_facet | Napoli, Nicola Langdahl, Bente. L. Ljunggren, Östen Lespessailles, Eric Kapetanos, George Kocjan, Tomaz Nikolic, Tatjana Eiken, Pia Petto, Helmut Moll, Thomas Lindh, Erik Marin, Fernando |
author_sort | Napoli, Nicola |
collection | PubMed |
description | This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeated measures. Changes in back pain (visual analogue scale) and health-related quality of life (HRQoL; EQ-5D questionnaire) were analysed using mixed models for repeated measures. Patients were analysed if they had a post-baseline visit, regardless of whether and for how long they took teriparatide. Of 1531 patients analysed (90.7% female, mean age: 70.3 years), 76 (5.0%) never took teriparatide. Median treatment duration was 23.6 months. The adjusted odds of clinical fracture decreased by 47% in the > 12- to 18-month treatment period (p = 0.013) compared with the first 6-month period, with no statistically significant reduction in the > 18- to 24-month interval. The clinical fracture rate remained stable during the 18 months’ post-teriparatide, when approximately 98% of patients took osteoporosis medication (51% bisphosphonates). Clinical vertebral fractures were reduced at every time period compared with the first 6 months. Adjusted mean back pain scores decreased and EQ-5D scores increased significantly at each post-baseline observation. In a real-life clinical setting, the risk of clinical fractures declined during 24 months of teriparatide treatment. This reduction was maintained 18 months after stopping teriparatide. In parallel, patients reported significant improvements in back pain and HRQoL. The results should be interpreted in the context of the non-controlled design of this observational study. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00223-018-0437-x) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6153867 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-61538672018-10-04 Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS) Napoli, Nicola Langdahl, Bente. L. Ljunggren, Östen Lespessailles, Eric Kapetanos, George Kocjan, Tomaz Nikolic, Tatjana Eiken, Pia Petto, Helmut Moll, Thomas Lindh, Erik Marin, Fernando Calcif Tissue Int Original Research This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeated measures. Changes in back pain (visual analogue scale) and health-related quality of life (HRQoL; EQ-5D questionnaire) were analysed using mixed models for repeated measures. Patients were analysed if they had a post-baseline visit, regardless of whether and for how long they took teriparatide. Of 1531 patients analysed (90.7% female, mean age: 70.3 years), 76 (5.0%) never took teriparatide. Median treatment duration was 23.6 months. The adjusted odds of clinical fracture decreased by 47% in the > 12- to 18-month treatment period (p = 0.013) compared with the first 6-month period, with no statistically significant reduction in the > 18- to 24-month interval. The clinical fracture rate remained stable during the 18 months’ post-teriparatide, when approximately 98% of patients took osteoporosis medication (51% bisphosphonates). Clinical vertebral fractures were reduced at every time period compared with the first 6 months. Adjusted mean back pain scores decreased and EQ-5D scores increased significantly at each post-baseline observation. In a real-life clinical setting, the risk of clinical fractures declined during 24 months of teriparatide treatment. This reduction was maintained 18 months after stopping teriparatide. In parallel, patients reported significant improvements in back pain and HRQoL. The results should be interpreted in the context of the non-controlled design of this observational study. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00223-018-0437-x) contains supplementary material, which is available to authorized users. Springer US 2018-06-16 2018 /pmc/articles/PMC6153867/ /pubmed/29909449 http://dx.doi.org/10.1007/s00223-018-0437-x Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Napoli, Nicola Langdahl, Bente. L. Ljunggren, Östen Lespessailles, Eric Kapetanos, George Kocjan, Tomaz Nikolic, Tatjana Eiken, Pia Petto, Helmut Moll, Thomas Lindh, Erik Marin, Fernando Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS) |
title | Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS) |
title_full | Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS) |
title_fullStr | Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS) |
title_full_unstemmed | Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS) |
title_short | Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS) |
title_sort | effects of teriparatide in patients with osteoporosis in clinical practice: 42-month results during and after discontinuation of treatment from the european extended forsteo® observational study (exfos) |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6153867/ https://www.ncbi.nlm.nih.gov/pubmed/29909449 http://dx.doi.org/10.1007/s00223-018-0437-x |
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