A Phase IV Study of the Safety and Efficacy of CinnoPar® in Iranian Patients with Osteoporosis

Autor: Ahmadreza Jamshidi, Farhad Gharibdoost, Sima Sedighi, Asghar Hajiabbasi, Amir-Hossein Salari, Alireza Khabbazi, Peyman Mottaghi, Ahmad Tahammoli Roudsari, Mehrdad Aghaei, Irandokht Shenavar Masooleh, Araz Sabzvari, Nassim Anjidani
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Journal of Osteoporosis, Vol 2021 (2021)
Druh dokumentu: article
ISSN: 2090-8059
2042-0064
DOI: 10.1155/2021/7584308
Popis: 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
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