Clinical Outcome of Romosozumab for Fresh Osteoporotic Vertebral Fracture

Abstract

Introduction: Herein, we investigated the clinical outcomes of patients with osteoporosis at high risk of fractures who were treated with romosozumab following fresh osteoporotic vertebral fractures (OVFs).

Methods: This study included 60 patients with osteoporosis who underwent romosozumab treatment at our clinic and whose follow-up period was >12 months. The bony union of the fractured vertebrae was diagnosed with a vertebral segmental angle (VSA) of the fractured vertebrae in the lateral views of the spine on regular radiographs, both in lateral and sitting positions, and the presence of an intervertebral cleft sign (ICS) in the lateral position 12 months after the treatment. To measure the correct bone mineral density (BMD) of the lumbar spine, all patients were divided into 2 groups: the "L1-4" group, comprising patients with L1, 2, 3, or 4 OVFs, and the "non-L1-4" group, comprising patients without L1-4 OVFs. The average BMD of the nonfractured vertebrae of L1, 2, 3, or 4, excluding the fractured vertebrae, was calculated in the "L1-4" group. The corrected BMD was then calculated using the values in the "non-L1-4" group and those of the nonfractured vertebrae in the "L1-4" group. Clinical assessment was measured using a visual analog scale (VAS) and the Roland-Morris Disability Questionnaire (RDQ).

Results: The difference between the lateral and sitting positions in VSA was within 5° in all cases and revealed excellent vertebral stability of the fractured vertebrae within 2-3 months of treatment. The ICS examination revealed that the bony union rate was 96.3% 12 months after the treatment. The BMD of the lumbar spine at 6 and 12 months and the proximal femur at 12 months were considerably higher than those before treatment. The BMD of the lumbar spine increased by 11.7% and 17.4%, and that of the proximal femur increased by 1% and 2.1% at 6 and 12 months, respectively. The VAS and RDQ of all patients considerably improved within 1 month of treatment.

Conclusions: Treatment with romosozumab considerably increased the BMD of the lumbar spine and proximal femur.