Real-world efficacy of a teriparatide biosimilar (RGB-10) compared with reference teriparatide on bone mineral density, trabecular bone score, and bone parameters assessed using quantitative ultrasound, 3D-SHAPER® and high-resolution peripheral computer tomography in postmenopausal women with osteoporosis and very high fracture risk

Abstract

A retrospective analysis comparing a teriparatide biosimilar (RGB-10) with reference teriparatide for osteoporosis treatment in postmenopausal women at high fracture risk found them to be therapeutically equivalent. Both provided significant improvements in lumber spine BMD, TBS, and other parameters of bone health, assessed using multiple diagnostic methods.

Purpose: To compare the therapeutic efficacy of a teriparatide biosimilar (RGB-10) with reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high fracture risk.

Methods: A retrospective analysis of 25 postmenopausal female patients treated for osteoporosis with RGB-10 for 24 months and a matched cohort of 25 patients treated with reference teriparatide. The following outcomes were assessed at baseline, 12 and 24 months: bone mineral density (BMD) at the lumbar spine, femoral neck and total hip using dual-energy x-ray absorptiometry (DXA) and integral, trabecular and cortical volumetric and surface BMD using 3D-SHAPER^® imaging, trabecular bone score (TBS), quantitative ultrasound (QUS) measurements, and high-resolution peripheral quantitative computed tomography (HRpQCT) imaging of the radius and tibia.

Results: No significant differences were observed between treatment groups in any of the measured parameters of BMD or bone health at baseline as well as in any timepoint when assessed using these various diagnostic methods. Both compounds provided equivalent significant improvements from baseline in measures of osteoporosis and fracture risk.

Conclusion: The results of the analysis demonstrate the therapeutic equivalence of the teriparatide biosimilar (RGB-10) to reference teriparatide for the treatment of osteoporosis in postmenopausal women at very high risk of fracture.

Keywords: BMD; Biosimilar; Fracture; HRpQCT; Osteoporosis; Teriparatide.

Fig. 1

Change from baseline in bone mineral density assessed using dual-energy X-ray absorptiometry at 12 and 24 months following treatment with reference teriparatide (orange) or teriparatide biosimilar (blue). Figures show BMD (a) at the lumbar spine, (b) femoral neck and (c) total hip. ** = p < 0.01, *** p < 0.001 versus baseline; NS, not significant versus baseline. Values are mean ± standard error of the mean (SEM)

Fig. 2

Change from baseline in bone mineral density (BMD) assessed using 3D-SHAPER^® imaging at 12 and 24 months following treatment with reference teriparatide (orange) or teriparatide biosimilar (blue). Figures show (a) trabecular volumetric BMD, (b) cortical thickness, (c) cortical volumetric BMD (d) cortical surface BMD, (e) integral volumetric BMD. ** = p < 0.01, *** p < 0.001 versus baseline; NS, not significant versus baseline. Values are mean ± standard error of the mean (SEM)

Fig. 3

Change from baseline in (a) trabecular bone scores and (b) qualitative ultrasound measurements at 12 and 24 months following treatment with reference teriparatide (orange) or teriparatide biosimilar (blue). ** = p < 0.01, * = p < 0.05 versus baseline; NS, not significant versus baseline. Values are median ± standard error of the mean (SEM)

Fig. 4

Change from baseline in high-resolution peripheral quantitative computed tomography (HRpQCT) structure and density parameters for the radius after (a) 12 and (b) 24 months of treatment and for the tibia after (c) 12 and (d) 24 months of treatment with reference teriparatide (orange) or teriparatide biosimilar (blue). * = p < 0.05 versus baseline. Values are median ± standard error of the mean (SEM)

Fig. 4

Change from baseline in high-resolution peripheral quantitative computed tomography (HRpQCT) structure and density parameters for the radius after (a) 12 and (b) 24 months of treatment and for the tibia after (c) 12 and (d) 24 months of treatment with reference teriparatide (orange) or teriparatide biosimilar (blue). * = p < 0.05 versus baseline. Values are median ± standard error of the mean (SEM)