A randomized controlled trial of teriparatide for accelerating bone union and improving clinical outcomes in patients with pertrochanteric fracture fixation

Abstract

Abstract 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.

Keywords

• Teriparatide
• Pertrochanteric fracture
• Union
• Fixation