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Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS)

BACKGROUND: The Extended Forsteo Observational Study (ExFOS) is a multinational, non-interventional, prospective, observational study that aims to provide real-life data on patients with osteoporosis treated with teriparatide for up to 24 months. It includes the new indications of osteoporosis in me...

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Autores principales: Aloumanis, Kyriakos, Kapetanos, George, Bartzis, Nikolaos, Drossinos, Vangelis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4457272/
https://www.ncbi.nlm.nih.gov/pubmed/26044820
http://dx.doi.org/10.1186/s12891-015-0600-8
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author Aloumanis, Kyriakos
Kapetanos, George
Bartzis, Nikolaos
Drossinos, Vangelis
author_facet Aloumanis, Kyriakos
Kapetanos, George
Bartzis, Nikolaos
Drossinos, Vangelis
author_sort Aloumanis, Kyriakos
collection PubMed
description BACKGROUND: The Extended Forsteo Observational Study (ExFOS) is a multinational, non-interventional, prospective, observational study that aims to provide real-life data on patients with osteoporosis treated with teriparatide for up to 24 months. It includes the new indications of osteoporosis in men and glucocorticoid-induced osteoporosis (GIOP). We describe the Greek subpopulation enrolled in this study and compare it with a similar cohort from the previous European Forsteo Observational Study (EFOS). METHODS: Baseline data were collected from the Greek cohort of ExFOS. Data included demographic characteristics, medical and osteoporosis history, disease status, prior use of medications, back pain and quality of life. RESULTS: Baseline data for 439 patients, enrolled at 31 sites, indicated the majority of patients were females (92.3 %), elderly [mean (standard deviation; SD) age 70.1 (9.8) years] and slightly overweight [mean (SD) body mass index 26.7 (4.3) kg/m(2)], with very low bone mineral density (mean T-score <−3 in lumbar spine or total hip) and at least one previous fracture (55.1 % of patients). Of the 439 patients, 19.8 % were osteoporosis treatment naïve, 88.4 % had experienced back pain during the previous 12 months, 68.1 % had experienced back pain at least fairly often during the previous month and 50.9 % reported moderate to severe limitation of activities due to back pain, with a mean (SD) of 4.2 (7.7) days spent in bed because of back pain during the previous month. Most baseline characteristics were numerically similar between the female ExFOS and EFOS cohorts; however, the rate of enrolment was faster in ExFOS (by approximately 45 %) and a history of fracture was recorded in 53.8 % of female patients in ExFOS versus 74.5 % in EFOS. CONCLUSIONS: Greek patients prescribed teriparatide in ExFOS had severe osteoporosis with a high risk of fractures and back pain. Female patients shared similarities with EFOS counterparts, reflecting a constant prescribing profile for use of teriparatide, although a noticeable difference in fracture history between the two study cohorts may indicate a change towards prescribing in less severely affected patients. The economic crisis in Greece did not appear to affect patient enrolment. Data are interpreted in the context of an observational setting.
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spelling pubmed-44572722015-06-06 Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS) Aloumanis, Kyriakos Kapetanos, George Bartzis, Nikolaos Drossinos, Vangelis BMC Musculoskelet Disord Research Article BACKGROUND: The Extended Forsteo Observational Study (ExFOS) is a multinational, non-interventional, prospective, observational study that aims to provide real-life data on patients with osteoporosis treated with teriparatide for up to 24 months. It includes the new indications of osteoporosis in men and glucocorticoid-induced osteoporosis (GIOP). We describe the Greek subpopulation enrolled in this study and compare it with a similar cohort from the previous European Forsteo Observational Study (EFOS). METHODS: Baseline data were collected from the Greek cohort of ExFOS. Data included demographic characteristics, medical and osteoporosis history, disease status, prior use of medications, back pain and quality of life. RESULTS: Baseline data for 439 patients, enrolled at 31 sites, indicated the majority of patients were females (92.3 %), elderly [mean (standard deviation; SD) age 70.1 (9.8) years] and slightly overweight [mean (SD) body mass index 26.7 (4.3) kg/m(2)], with very low bone mineral density (mean T-score <−3 in lumbar spine or total hip) and at least one previous fracture (55.1 % of patients). Of the 439 patients, 19.8 % were osteoporosis treatment naïve, 88.4 % had experienced back pain during the previous 12 months, 68.1 % had experienced back pain at least fairly often during the previous month and 50.9 % reported moderate to severe limitation of activities due to back pain, with a mean (SD) of 4.2 (7.7) days spent in bed because of back pain during the previous month. Most baseline characteristics were numerically similar between the female ExFOS and EFOS cohorts; however, the rate of enrolment was faster in ExFOS (by approximately 45 %) and a history of fracture was recorded in 53.8 % of female patients in ExFOS versus 74.5 % in EFOS. CONCLUSIONS: Greek patients prescribed teriparatide in ExFOS had severe osteoporosis with a high risk of fractures and back pain. Female patients shared similarities with EFOS counterparts, reflecting a constant prescribing profile for use of teriparatide, although a noticeable difference in fracture history between the two study cohorts may indicate a change towards prescribing in less severely affected patients. The economic crisis in Greece did not appear to affect patient enrolment. Data are interpreted in the context of an observational setting. BioMed Central 2015-06-05 /pmc/articles/PMC4457272/ /pubmed/26044820 http://dx.doi.org/10.1186/s12891-015-0600-8 Text en © Aloumanis et al. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Aloumanis, Kyriakos
Kapetanos, George
Bartzis, Nikolaos
Drossinos, Vangelis
Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS)
title Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS)
title_full Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS)
title_fullStr Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS)
title_full_unstemmed Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS)
title_short Teriparatide use during an economic crisis: baseline data from the Greek cohort of the Extended Forsteo Observational Study (ExFOS)
title_sort teriparatide use during an economic crisis: baseline data from the greek cohort of the extended forsteo observational study (exfos)
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4457272/
https://www.ncbi.nlm.nih.gov/pubmed/26044820
http://dx.doi.org/10.1186/s12891-015-0600-8
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