Ahmadreza Jamshidi: Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran. ORCID
Farhad Gharibdoost: Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran. ORCID
Sima Sedighi: Bones, Joints, and Connective Tissue Research Center, Golestan University of Medical Sciences, Gorgan, Iran. ORCID
Asghar Hajiabbasi: Guilan Rheumatology Research Center, Department of Rheumatology, Razi Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran. ORCID
Amir-Hossein Salari: Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Alireza Khabbazi: Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. ORCID
Peyman Mottaghi: Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. ORCID
Ahmad Tahammoli Roudsari: Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran. ORCID
Mehrdad Aghaei: Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran. ORCID
Irandokht Shenavar Masooleh: Guilan Rheumatology Research Center, Department of Rheumatology, Razi Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran. ORCID
Araz Sabzvari: CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran.
Nassim Anjidani: Medical Department, Orchid Pharmed Company, Tehran, Iran. ORCID
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���g 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 ( < 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.
