PMID- 34194720
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210702
IS  - 2090-8059 (Print)
IS  - 2042-0064 (Electronic)
IS  - 2042-0064 (Linking)
VI  - 2021
DP  - 2021
TI  - A  Phase IV Study of the Safety and Efficacy of CinnoPar((R)) in Iranian Patients 
      with Osteoporosis.
PG  - 7584308
LID - 10.1155/2021/7584308 [doi]
LID - 7584308
AB  - 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((R)), 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 mug 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.
CI  - Copyright (c) 2021 Ahmadreza Jamshidi et al.
FAU - Jamshidi, Ahmadreza
AU  - Jamshidi A
AUID- ORCID: 0000-0002-0464-8715
AD  - Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, 
      Iran.
FAU - Gharibdoost, Farhad
AU  - Gharibdoost F
AUID- ORCID: 0000-0002-0324-2609
AD  - Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, 
      Iran.
FAU - Sedighi, Sima
AU  - Sedighi S
AUID- ORCID: 0000-0002-0328-0728
AD  - Bones, Joints, and Connective Tissue Research Center, Golestan University of 
      Medical Sciences, Gorgan, Iran.
FAU - Hajiabbasi, Asghar
AU  - Hajiabbasi A
AUID- ORCID: 0000-0001-7892-7664
AD  - Guilan Rheumatology Research Center, Department of Rheumatology, Razi Hospital, 
      School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.
FAU - Salari, Amir-Hossein
AU  - Salari AH
AD  - Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, 
      Iran.
FAU - Khabbazi, Alireza
AU  - Khabbazi A
AUID- ORCID: 0000-0002-9482-6967
AD  - Connective Tissue Diseases Research Center, Tabriz University of Medical 
      Sciences, Tabriz, Iran.
FAU - Mottaghi, Peyman
AU  - Mottaghi P
AUID- ORCID: 0000-0002-9810-4136
AD  - Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, 
      Iran.
FAU - Tahammoli Roudsari, Ahmad
AU  - Tahammoli Roudsari A
AUID- ORCID: 0000-0002-5431-4836
AD  - Department of Internal Medicine, School of Medicine, Hamadan University of 
      Medical Sciences, Hamadan, Iran.
FAU - Aghaei, Mehrdad
AU  - Aghaei M
AUID- ORCID: 0000-0002-0143-7306
AD  - Golestan Rheumatology Research Center, Golestan University of Medical Sciences, 
      Gorgan, Iran.
FAU - Shenavar Masooleh, Irandokht
AU  - Shenavar Masooleh I
AUID- ORCID: 0000-0002-3967-7022
AD  - Guilan Rheumatology Research Center, Department of Rheumatology, Razi Hospital, 
      School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.
FAU - Sabzvari, Araz
AU  - Sabzvari A
AD  - CinnaGen Medical Biotechnology Research Center, Alborz University of Medical 
      Sciences, Karaj, Iran.
AD  - Orchid Pharmed Company, Tehran, Iran.
FAU - Anjidani, Nassim
AU  - Anjidani N
AUID- ORCID: 0000-0001-7247-6743
AD  - Medical Department, Orchid Pharmed Company, Tehran, Iran.
LA  - eng
PT  - Journal Article
DEP - 20210531
PL  - United States
TA  - J Osteoporos
JT  - Journal of osteoporosis
JID - 101538878
PMC - PMC8184341
COIS- The authors declare that they have no conflicts of interest.
EDAT- 2021/07/02 06:00
MHDA- 2021/07/02 06:01
PMCR- 2021/05/31
CRDT- 2021/07/01 06:58
PHST- 2020/06/22 00:00 [received]
PHST- 2021/04/25 00:00 [revised]
PHST- 2021/05/24 00:00 [accepted]
PHST- 2021/07/01 06:58 [entrez]
PHST- 2021/07/02 06:00 [pubmed]
PHST- 2021/07/02 06:01 [medline]
PHST- 2021/05/31 00:00 [pmc-release]
AID - 10.1155/2021/7584308 [doi]
PST - epublish
SO  - J Osteoporos. 2021 May 31;2021:7584308. doi: 10.1155/2021/7584308. eCollection 
      2021.