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.
Highlights
Osteoporosis is defined as decreased bone mineral density (BMD), which results in increased fracture risk and its subsequent complications [1]
In Iran, it is estimated that 17% of the adults over 30 years of age have osteoporosis in the lumbar spine and 35% have osteopenia [3]. e high prevalence of this disease in Iran may increase the risk of its complications
Design. e present trial was a phase IV, observational, cohort, single-arm, prospective study conducted in multiple centers across seven cities of Iran from September 2015 to March 2019 to evaluate the safety and effectiveness of Iranian biosimilar teriparatide in patients diagnosed with osteoporosis
Summary
Osteoporosis is defined as decreased bone mineral density (BMD), which results in increased fracture risk and its subsequent complications [1]. In the United States, the prevalence of osteoporosis at the femoral neck or lumbar spine is estimated to be 10% in adults older than 50 years of age [2]. In Iran, it is estimated that 17% of the adults over 30 years of age have osteoporosis in the lumbar spine and 35% have osteopenia [3]. E high prevalence of this disease in Iran may increase the risk of its complications. Osteoporosis, imposes a significant financial burden on the patients, their caregivers, and healthcare systems and decreases patients’ quality of life and increases their. Journal of Osteoporosis morbidity and mortality [4]. It works in a similar fashion to endogenous PTH by increasing bone turnover [6]
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