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A Phase Iv Study of the Safety and Efficacy of Cinnopar®In Iranian Patients With Osteoporosis Publisher



Jamshidi A1 ; Gharibdoost F1 ; Sedighi S2 ; Hajiabbasi A3 ; Salari AH1 ; Khabbazi A4 ; Mottaghi P5 ; Tahammoli Roudsari A6 ; Aghaei M7 ; Shenavar Masooleh I3 ; Sabzvari A8, 9 ; Anjidani N10
Authors
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Authors Affiliations
  1. 1. Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Bones, Joints, and Connective Tissue Research Center, Golestan University of Medical Sciences, Gorgan, Iran
  3. 3. Guilan Rheumatology Research Center, Department of Rheumatology, Razi Hospital, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran
  4. 4. Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
  5. 5. Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
  6. 6. Department of Internal Medicine, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
  7. 7. Golestan Rheumatology Research Center, Golestan University of Medical Sciences, Gorgan, Iran
  8. 8. CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran
  9. 9. Orchid Pharmed Company, Tehran, Iran
  10. 10. Medical Department, Orchid Pharmed Company, Tehran, Iran

Source: Journal of Osteoporosis Published:2021


Abstract

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. © 2021 Ahmadreza Jamshidi et al.
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