Efficacy of Recombinant Human Parathyroid Hormone versus Vertebral Augmentation Procedure on Patients with Acute Osteoporotic Vertebral Compression Fracture

Abstract

Objective: Although widely used in clinical practice, vertebral augmentation procedure (VAP) for osteoporotic vertebral compression fracture (OVCF) is not supported. Recently, the effect of recombinant human parathyroid hormone (1-34) (rhPTH) has been paid great attention for its efficacy in anti-osteoporosis and bone union. This study aims to explore the outcome of rhPTH on acute OVCF and compare it with VAP to clarify its therapeutic advantages.

Methods: The retrospective study comprised 71 acute OVCF patients from January 2015 to March 2020: 22 received rhPTH treatment (rhPTH group) and 49 underwent VAP (VAP group). The rhPTH group was 15 women and seven men with an average of 76.18 years, and the VAP group were 35 women and 14 men with an average of 73.63 years. The thoracic/lumbar vertebrae were 14/8 in the rhPTH group and 29/20 in the VAP group. The average follow-up period was 14.05 months in the rhPTH group and 13.82 months in the VAP group. The two groups were assessed regarding the visual analog score (VAS), Oswestry Disability Index (ODI), OVCF bone union, bone mineral density (BMD), kyphotic angle (KA), anterior and posterior border height (ABH and PBH, respectively), adverse events and the health-related quality of life assessed by short form-36 health survey scores (SF-36). Categorical variables were analyzed by chi-square test and continuous variables between groups were analyzed by independent samples t-test or Mann-Whitney U test according to the normality.

Results: During the follow-up, the VAS was significantly lower in the rhPTH group than in the VAP group at month 3 (0.39 ± 0.6 vs 0.68 ± 0.651) (p = 0.047), month 6 (0.45 ± 0.60 vs 2.18 ± 1.22) (p < 0.001), and month 12 (0.45 ± 0.60 vs 2.43 ± 1.49) (p < 0.001). At month 12, the ODI was significantly lower in the rhPTH group (18.59 ± 3.33%) than in the VAP group (28.93 ± 16.71%) (p < 0.001). Bone bridge was detected on sagittal computed tomography images of all fractured vertebrae in the rhPTH group. The BMD was significantly higher in the rhPTH group (87.66 ± 5.91 Hounsfield units [HU]) than in the VAP group (68.15 ± 11.32HU) (p < 0.001). There were no significant differences in the changes in KA, ABH, and PBH between groups (all p > 0.05). The incidence of new OVCF was significantly lower in the rhPTH group than in the VAP group (p = 0.042). All scores of SF-36 were significantly higher in the rhPTH group than in the VAP group (all p < 0.05).

Conclusion: In acute OVCF patients, rhPTH was better than VAP in increasing spinal BMD to promote OVCF healing, reduce new OVCF, and improve back pain, physical ability, and health-related quality of life.

Keywords: fracture healing; osteoporosis; parathyroid hormone; procedures; spine.

Fig. 1

Fracture union assessed by ImageJ after rhPTH treatment. The original sagittal CT image of L2 (A, arrowhead). The region of interest is drawn according to the L2 outline (B, yellow line). Bone bridge connecting the upper and lower endplates is detected by setting the CT values of 200–1000 HU (C, red color region), indicating bone healing. HU, Hounsfield unit

Fig. 2

Changes in VAS (A) and ODI (B) before and after treatment between groups at different time points, respectively. *Means difference between groups was significant (p < 0.001)

Fig. 3

(A) No significant differences in KA were found between the rhPTH and the VAP groups at baseline or month 12 (both p > 0.05). (B) No significant differences in KA increment were found between groups from baseline to month 12 (p > 0.05). KA, kyphosis angle

Fig. 4

(A) No significant differences in the ABH and PBH were found between groups at baseline or month 12. (B) There were no significant differences in the loss rates of ABH and PBH between groups from baseline to month 12, respectively. ABH, anterior border height; PBH, posterior border height

Fig. 5

(A, B) The KA, ABH, and PBH in a 65‐year‐old female with acute L2 OVCF changes from 7°, 2.40, and 2.6 cm before treatment (A) to 9°, 2.25, and 2.55 cm following rhPTH at month 12 (B). (C, D) The KA, ABH, and PBH in a 67‐year‐old female with fresh T12 OVCF changes from 12°, 2.00, and 2.50 cm before treatment (C) to 13°, 1.85, and 2.50 cm after VAP treatment at month 12 (D). ABH, anterior border height; KA, kyphosis angle; PBH, posterior border height

Fig. 6

No significant differences in spinal BMD in the rhPTH and VAP groups at baseline (p = 0.173). At month 12, the BMD in the rhPTH group was significantly higher than in the VAP group (p < 0.001). BMD, bone mineral density