Soroush Mohsen G, Kheirandish Maryam, Soroosh Soosan
Rheumatology Unit, AJA University of Medical Sciences, Tehran, Iran.
Department of Internal Medicine, Shahid Beheshti Hospital, Mazandaran University of Medical Sciences, Noshahr, Iran.
Bone Rep. 2023 May 25;18:101689. doi: 10.1016/j.bonr.2023.101689. eCollection 2023 Jun.
Teriparatide is a recombinant analog of the parathyroid hormone and an anabolic treatment modality for osteoporosis. This study aimed to evaluate the effectiveness of biosimilar teriparatide (CinnoPar®, CinnaGen Co., Iran) in osteoporotic patients after at least one year of treatment.
In this multi-center, single-arm study, 239 eligible patients received subcutaneous injections of biosimilar teriparatide 20 μg once daily for at least one year. The main outcome measure was the change in bone mineral density (BMD) T-score from baseline (pre-treatment) to end of the study (post-treatment). In addition, the change in the fracture risk assessment tool (FRAX) score was calculated to estimate the 10-year probability of major and hip fractures pre-and post-treatment.
A total of 239 patients (age, 63 ± 12.14 years; female, 88.28 %) were included, of which 27.62 % (66/239), 14.64 % (35/239), and 57.74 % (138/239) received biosimilar teriparatide for 12-16 months, 17-20 months, and 21-24 months, respectively. From baseline to end of the study, the T-score at the lumbar spine increased from -2.67 ± 1.04 to -2.26 ± 1.11 (mean percent change, 13.07 ± 62.89; p-value<0.001). Similarly, the T-score at femoral neck increased from -2.18 ± 0.87 to -2.09 ± 0.93 (mean percent change, 3.81 ± 31.52; p-value = 0.006). The proportions of patients with maintained or improved BMD T-score at the lumbar spine and femoral neck sites were 85.36 % (204/239) and 69.04 % (165/239), respectively. Similar results were obtained in subgroups of patients with rheumatoid arthritis and those with a history of a previous fracture or parental hip fracture. FRAX scores did not change significantly during the study (p-values of 0.551 and 0.973 at the lumbar spine and femoral neck, respectively).
We observed considerable improvements in BMD following treatment with the biosimilar teriparatide for one year or more. The biosimilar teriparatide can be considered as an effective treatment option in female and male patients with osteoporosis.
特立帕肽是一种甲状旁腺激素的重组类似物，是骨质疏松症的一种促合成治疗方式。本研究旨在评估生物类似物特立帕肽（CinnoPar®，伊朗CinnaGen公司）在治疗至少一年后的骨质疏松症患者中的有效性。
在这项多中心、单臂研究中，239名符合条件的患者接受皮下注射生物类似物特立帕肽20μg，每日一次，持续至少一年。主要结局指标是骨密度（BMD）T值从基线（治疗前）到研究结束（治疗后）的变化。此外，计算骨折风险评估工具（FRAX）评分的变化，以估计治疗前后10年主要骨折和髋部骨折的概率。
共纳入239名患者（年龄，63±12.14岁；女性，88.28%），其中27.62%（66/239）、14.64%（35/239）和57.74%（138/239）分别接受生物类似物特立帕肽治疗12 - 16个月、17 - 20个月和21 - 24个月。从基线到研究结束，腰椎的T值从 -2.67±1.04增加到 -2.26±1.11（平均变化百分比，13.07±62.89；p值<0.001）。同样，股骨颈的T值从 -2.18±0.87增加到 -2.09±0.93（平均变化百分比，3.81±31.52；p值 = 0.006）。腰椎和股骨颈部位骨密度T值维持或改善的患者比例分别为85.36%（204/239）和69.04%（165/239）。类风湿关节炎患者亚组以及有既往骨折或父母髋部骨折病史的患者亚组也得到了类似结果。研究期间FRAX评分没有显著变化（腰椎和股骨颈的p值分别为0.551和0.973）。
我们观察到使用生物类似物特立帕肽治疗一年或更长时间后骨密度有显著改善。生物类似物特立帕肽可被视为骨质疏松症女性和男性患者的一种有效治疗选择。
