Tanavalee Chotetawan, Ngarmukos Srihatach, Amarase Chavarin, Tantavisut Saran, Jaruthien Nonn, Tanavalee Aree
Biologics for Knee Osteoarthritis Research Unit, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Hip Fracture Research Unit, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Sci Rep. 2025 Jun 3;15(1):19465. doi: 10.1038/s41598-025-03720-2.
This prospective, double-blind, placebo-controlled, randomized trial evaluated the effects of teriparatide following pertrochanteric fracture fixation on bone healing and clinical outcomes. Among 50 participants having fractures and undergoing surgical fixation, 25 were randomly assigned to each group to receive daily teriparatide or placebo for 12 weeks and were followed until 24 weeks postoperatively. The primary outcome was the radiographic bone union. The secondary outcome was clinical results, including Harris hip scores (HHS) and performance-based tests evaluated at the postoperative 2nd, 4th, 6th, 12th, and 24th weeks, and spine and contralateral hip bone mass density (BMD), comparing admission and the 24th week. There were no statistically significant differences in baseline characteristics, including age, sex, fracture classification, affected side, HHS, BMD, and blood test results. The mean and standard deviation of radiographic bone union time of the teriparatide and the placebo groups were 7.44 ± 3.34 weeks and 10.56 ± 4.98 weeks, respectively, with significant differences (p, 0.0083). From the 6th week, both teriparatide and placebo groups had significantly improved HHS (p, 0.008 and 0.0205, respectively) and time up-and-go test (TUGT) (p, 0.0348 and 0.0237, respectively). In the 24th week, the five-time sit-to-stand test (5 × SST) of teriparatide and placebo groups was significantly improved (p, 0.0013 and 0.0412, respectively). However, there were no differences in HHS, TUGT and 5 × SST between groups at all follow-up time points. In the 24th week, the teriparatide group had less decrease in spine, femoral neck, and total hip BMD from baseline to the placebo group; however, these differences were insignificant. In conclusion, a 12-week teriparatide administration following intertrochanteric fracture fixation significantly shortened the fracture healing time. Although there were no differences in improved clinical outcomes, the teriparatide group had less decline in BMD at 24 weeks than the placebo group.
这项前瞻性、双盲、安慰剂对照、随机试验评估了特立帕肽在股骨转子间骨折固定术后对骨愈合和临床结局的影响。在50例发生骨折并接受手术固定的参与者中，每组随机分配25例，分别接受每日一次的特立帕肽或安慰剂治疗，为期12周，并随访至术后24周。主要结局是影像学骨愈合。次要结局是临床结果，包括Harris髋关节评分（HHS）以及在术后第2、4、6、12和24周评估的基于功能表现的测试，以及比较入院时和第24周时的脊柱和对侧髋关节骨密度（BMD）。在包括年龄、性别、骨折分类、患侧、HHS、BMD和血液检查结果等基线特征方面，两组无统计学显著差异。特立帕肽组和安慰剂组影像学骨愈合时间的均值和标准差分别为7.44±3.34周和10.56±4.98周，差异有统计学意义（p = 0.0083）。从第6周起，特立帕肽组和安慰剂组的HHS（分别为p = 0.008和0.0205）和计时起立行走测试（TUGT）（分别为p = 0.0348和0.0237）均有显著改善。在第24周时，特立帕肽组和安慰剂组的五次坐立试验（5×SST）均有显著改善（分别为p = 0.0013和0.0412）。然而，在所有随访时间点，两组之间的HHS、TUGT和5×SST均无差异。在第24周时，与安慰剂组相比，特立帕肽组从基线至第24周时脊柱、股骨颈和全髋关节BMD的下降幅度较小；然而，这些差异无统计学意义。总之，股骨转子间骨折固定术后给予12周的特立帕肽显著缩短了骨折愈合时间。虽然在改善临床结局方面无差异，但特立帕肽组在24周时BMD的下降幅度低于安慰剂组。
