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A Phase IV Study of the Safety and Efficacy of CinnoPar(®) in Iranian Patients with Osteoporosis
The safety of teriparatide has been studied in various phase III and phase IV trials. However, a postmarketing study of the biosimilar of teriparatide, CinnoPar(®), has not been conducted on Iranian patients. This was a phase IV study conducted on osteoporotic patients who received an Iranian teripa...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184341/ https://www.ncbi.nlm.nih.gov/pubmed/34194720 http://dx.doi.org/10.1155/2021/7584308 |
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author | Jamshidi, Ahmadreza Gharibdoost, Farhad Sedighi, Sima Hajiabbasi, Asghar Salari, Amir-Hossein Khabbazi, Alireza Mottaghi, Peyman Tahammoli Roudsari, Ahmad Aghaei, Mehrdad Shenavar Masooleh, Irandokht Sabzvari, Araz Anjidani, Nassim |
author_facet | Jamshidi, Ahmadreza Gharibdoost, Farhad Sedighi, Sima Hajiabbasi, Asghar Salari, Amir-Hossein Khabbazi, Alireza Mottaghi, Peyman Tahammoli Roudsari, Ahmad Aghaei, Mehrdad Shenavar Masooleh, Irandokht Sabzvari, Araz Anjidani, Nassim |
author_sort | Jamshidi, Ahmadreza |
collection | PubMed |
description | The safety of teriparatide has been studied in various phase III and phase IV trials. However, a postmarketing study of the biosimilar of teriparatide, CinnoPar(®), has not been conducted on Iranian patients. This was a phase IV study conducted on osteoporotic patients who received an Iranian teriparatide biosimilar with a dose of 20 μg daily. The primary outcome of this study was to monitor for adverse events (AEs). Effectiveness as the secondary outcome was measured using the EQ-5D quality-of-life questionnaire and back pain Visual Analogue Scale (VAS) score. Among 193 analyzed patients between September 2015 and March 2019, the most common AEs were hypercalcemia (4%), nausea, and pain (3%). No deaths, serious AEs, or other significant AEs occurred in this study. The mean EQ-5D scores decreased after the course of the treatment from 2.3 ± 0.66 at the baseline to 2 ± 0.66. The mean back pain VAS scores also decreased from 4.9 ± 3.6 at baseline to 1.8 ± 2.1 at the end of the study. Both changes were statistically significant (p < 0.001). Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients. |
format | Online Article Text |
id | pubmed-8184341 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Hindawi |
record_format | MEDLINE/PubMed |
spelling | pubmed-81843412021-06-29 A Phase IV Study of the Safety and Efficacy of CinnoPar(®) in Iranian Patients with Osteoporosis Jamshidi, Ahmadreza Gharibdoost, Farhad Sedighi, Sima Hajiabbasi, Asghar Salari, Amir-Hossein Khabbazi, Alireza Mottaghi, Peyman Tahammoli Roudsari, Ahmad Aghaei, Mehrdad Shenavar Masooleh, Irandokht Sabzvari, Araz Anjidani, Nassim J Osteoporos Research Article The safety of teriparatide has been studied in various phase III and phase IV trials. However, a postmarketing study of the biosimilar of teriparatide, CinnoPar(®), has not been conducted on Iranian patients. This was a phase IV study conducted on osteoporotic patients who received an Iranian teriparatide biosimilar with a dose of 20 μg daily. The primary outcome of this study was to monitor for adverse events (AEs). Effectiveness as the secondary outcome was measured using the EQ-5D quality-of-life questionnaire and back pain Visual Analogue Scale (VAS) score. Among 193 analyzed patients between September 2015 and March 2019, the most common AEs were hypercalcemia (4%), nausea, and pain (3%). No deaths, serious AEs, or other significant AEs occurred in this study. The mean EQ-5D scores decreased after the course of the treatment from 2.3 ± 0.66 at the baseline to 2 ± 0.66. The mean back pain VAS scores also decreased from 4.9 ± 3.6 at baseline to 1.8 ± 2.1 at the end of the study. Both changes were statistically significant (p < 0.001). Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients. Hindawi 2021-05-31 /pmc/articles/PMC8184341/ /pubmed/34194720 http://dx.doi.org/10.1155/2021/7584308 Text en Copyright © 2021 Ahmadreza Jamshidi et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Jamshidi, Ahmadreza Gharibdoost, Farhad Sedighi, Sima Hajiabbasi, Asghar Salari, Amir-Hossein Khabbazi, Alireza Mottaghi, Peyman Tahammoli Roudsari, Ahmad Aghaei, Mehrdad Shenavar Masooleh, Irandokht Sabzvari, Araz Anjidani, Nassim A Phase IV Study of the Safety and Efficacy of CinnoPar(®) in Iranian Patients with Osteoporosis |
title | A Phase IV Study of the Safety and Efficacy of CinnoPar(®) in Iranian Patients with Osteoporosis |
title_full | A Phase IV Study of the Safety and Efficacy of CinnoPar(®) in Iranian Patients with Osteoporosis |
title_fullStr | A Phase IV Study of the Safety and Efficacy of CinnoPar(®) in Iranian Patients with Osteoporosis |
title_full_unstemmed | A Phase IV Study of the Safety and Efficacy of CinnoPar(®) in Iranian Patients with Osteoporosis |
title_short | A Phase IV Study of the Safety and Efficacy of CinnoPar(®) in Iranian Patients with Osteoporosis |
title_sort | phase iv study of the safety and efficacy of cinnopar(®) in iranian patients with osteoporosis |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184341/ https://www.ncbi.nlm.nih.gov/pubmed/34194720 http://dx.doi.org/10.1155/2021/7584308 |
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