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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)

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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). In: Calcified Tissue International. 2018 ; Vol. 103, No. 4. pp. 359-371.

Bibtex

@article{54de0bf35ded407bbd2098b174b0e0da,
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{\textregistered} Observational Study (ExFOS)",
abstract = "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{\textregistered} 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.",
author = "Nicola Napoli and Langdahl, {Bente L} and {\"O}sten Ljunggren and Eric Lespessailles and George Kapetanos and Tomaz Kocjan and Tatjana Nikolic and Pia Eiken and Helmut Petto and Thomas Moll and Erik Lindh and Fernando Marin",
year = "2018",
doi = "10.1007/s00223-018-0437-x",
language = "English",
volume = "103",
pages = "359--371",
journal = "Calcified Tissue International",
issn = "0171-967X",
publisher = "Springer New York LLC",
number = "4",

}

RIS

TY - JOUR

T1 - Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice

T2 - 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS)

AU - Napoli, Nicola

AU - Langdahl, Bente L

AU - Ljunggren, Östen

AU - Lespessailles, Eric

AU - Kapetanos, George

AU - Kocjan, Tomaz

AU - Nikolic, Tatjana

AU - Eiken, Pia

AU - Petto, Helmut

AU - Moll, Thomas

AU - Lindh, Erik

AU - Marin, Fernando

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

U2 - 10.1007/s00223-018-0437-x

DO - 10.1007/s00223-018-0437-x

M3 - Journal article

C2 - 29909449

VL - 103

SP - 359

EP - 371

JO - Calcified Tissue International

JF - Calcified Tissue International

SN - 0171-967X

IS - 4

ER -

ID: 54747697