Perioperative teriparatide for preventing proximal junctional kyphosis and failure in patients with osteoporosis after adult thoracolumbar spinal deformity surgery: a prospective randomized controlled trial.
Jin-Ho Park, Ohsang Kwon, Jae Heouk Choi, Jin S Yeom, Sang-Min Park, Cheol Hyun Kim, Ho-Joong Kim
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引用次数: 0
Abstract
We conducted a randomized controlled trial to assess the preventive effect of perioperative teriparatide on proximal junctional kyphosis and proximal junctional failure (PJF) in osteoporosis patients undergoing adult spinal deformity surgery. Teriparatide (experimental group) and denosumab (active control) were administered. The teriparatide group demonstrated significantly better PJF incidence and VAS for back pain, EQ-5D than the control group.
Purpose: This randomized controlled trial is aimed at investigating and comparing the effects of perioperative teriparatide and denosumab as an active control for preventing proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) in patients with osteoporosis after adult spinal deformity (ASD) surgery.
Methods: A total of 64 patients with osteoporosis, who planned to undergo ASD surgery, were randomly assigned to the teriparatide and denosumab groups. Treatment with teriparatide or denosumab in both groups was conducted from 3 months preoperatively to 3 months postoperatively based on the standard regimen for each medication. The primary outcome was PJK and PJF incidence within 1 year after ASD surgery. The secondary outcomes were patient-reported outcomes (PROs), bone mineral density (BMD), and dual-energy X-ray absorptiometry (DEXA) t-score of the hip.
Results: The teriparatide group showed a lower incidence of PJK than the denosumab group (17.2% vs. 33.3%), although this difference was not statistically significant (p = 0.165 in a modified intention-to-treat (mITT) analysis). Furthermore, the teriparatide group exhibited a significantly lower incidence of PJF than the denosumab group (3.4% vs. 22.2%; p = 0.034 in the mITT analysis). As for the secondary outcomes, no significant differences in BMD of the hip were observed between the two groups at the 1-year follow-up. The teriparatide group showed significantly improved postoperative VAS for back pain and EQ-5D score.
Conclusions: Perioperative teriparatide treatment of patients with osteoporosis after ASD surgery effectively reduced PJF incidence and postoperative back pain.
我们进行了一项随机对照试验，以评估围手术期特立帕肽对骨质疏松症患者接受成人脊柱畸形手术后近端关节后凸和近端关节功能衰竭（PJF）的预防作用。给予特立帕肽（实验组）和地诺单抗（主动对照组）。特立帕肽组PJF发生率和VAS对背痛、EQ-5D的评分均明显优于对照组。目的：本随机对照试验旨在调查和比较特立帕肽和地诺单抗作为预防成人脊柱畸形（ASD）手术后骨质疏松患者近端关节后凸（PJK）和近端关节功能衰竭（PJF）的围手术期有效对照的效果。方法：将64例拟行ASD手术的骨质疏松患者随机分为特立帕肽组和地诺单抗组。术前3个月至术后3个月，两组患者均采用特立帕肽或地诺单抗治疗。主要观察指标为ASD术后1年内PJK和PJF的发生率。次要结果是患者报告的结果（PROs）、骨密度（BMD）和髋关节双能x线吸收仪（DEXA） t评分。结果：特立帕肽组的PJK发生率低于地诺单抗组（17.2% vs 33.3%），尽管这一差异无统计学意义（修改意向治疗（mITT）分析p = 0.165）。此外，特立帕肽组PJF的发生率显著低于地诺单抗组(3.4% vs 22.2%；在mITT分析中p = 0.034)。次要结局方面，随访1年时，两组患者髋关节骨密度无显著差异。特立帕肽组术后腰痛VAS评分和EQ-5D评分明显改善。结论：特立帕肽围手术期治疗ASD术后骨质疏松患者可有效降低PJF的发生率和术后背部疼痛。
期刊介绍：
An international multi-disciplinary journal which is a joint initiative between the International Osteoporosis Foundation and the National Osteoporosis Foundation of the USA, Osteoporosis International provides a forum for the communication and exchange of current ideas concerning the diagnosis, prevention, treatment and management of osteoporosis and other metabolic bone diseases.
It publishes: original papers - reporting progress and results in all areas of osteoporosis and its related fields; review articles - reflecting the present state of knowledge in special areas of summarizing limited themes in which discussion has led to clearly defined conclusions; educational articles - giving information on the progress of a topic of particular interest; case reports - of uncommon or interesting presentations of the condition.
While focusing on clinical research, the Journal will also accept submissions on more basic aspects of research, where they are considered by the editors to be relevant to the human disease spectrum.
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