Effects of romosozumab on the peripheral and axial skeleton in postmenopausal women at high fracture risk: real-world evidence from DXA and HR-pQCT data.

Abstract

Evidence on the effects of romosozumab mainly concerns axial aBMD. In 28 postmenopausal women, we found that spine and hip aBMD (DXA) significantly increased, while volumetric BMD, microarchitecture, and strength at the radius and tibia (HR-pQCT) remained unchanged or deteriorated. Most HR-pQCT changes did not differ from those in age-matched women on bisphosphonate treatment. We assessed the effects of ROMO treatment on the axial skeleton using dual-energy X-ray absorptiometry (DXA) and on the peripheral skeleton using high-resolution peripheral quantitative CT (HR-pQCT) in real-world data of postmenopausal women at high fracture risk and compared HR-pQCT changes with those during bisphosphonate (BP) treatment. As part of regular care in our hospital, DXA (lumbar spine, hip) and HR-pQCT (distal radius, distal tibia) were performed before the start (T0) and after 12 months (T1) of ROMO treatment. HR-pQCT results were compared with those in 55 age-matched women receiving BP treatment after a recent fracture. ROMO data were available of 28 women (72.4 ± 7.6 years, 67.9% treatment-naïve). At T0, areal bone mineral density (aBMD) T-scores were -2.3 ± 1.6 (lumbar spine), -2.1 ± 0.7 (total hip), and -2.7 ± 0.5 (femoral neck). At T1, aBMD was significantly higher than at T0 at the lumbar spine (+9.6% [IQR = 6.6,15.7], p < 0.001) and total hip (+4.4 ± 5.8%, p = 0.001) but not femoral neck. At the distal radius, a significant decrease was found in total (-2.4%, [-4.3,-0.1], p = 0.004) and trabecular (-1.7%, [-3.5,0.5], p = 0.013) volumetric BMD and in trabecular number, cortical thickness, and cortical area. Trabecular area and separation significantly increased. At the distal tibia, a significant change was found in trabecular number (decrease) and in trabecular thickness, separation, and heterogeneity (increase). Changes in radial and tibial stiffness and failure load were not significant. Most HR-pQCT changes did not significantly differ from those in the BP cohort. After 12 months of ROMO treatment, aBMD increased significantly at the lumbar spine and total hip, while volumetric BMD, microarchitecture, and strength at the peripheral skeleton did not change or deteriorated.