Abstract

Denosumab and romosozumab, a recently approved new drug, are effective and widely known molecular-targeted drugs for postmenopausal osteoporosis treatment. However, no studies have directly compared their therapeutic effects or safety in postmenopausal osteoporosis. This retrospective observational registry study compared the efficacy of 12-month denosumab or romosozumab treatment in postmenopausal osteoporosis patients. The primary outcome was the change in bone mineral density (BMD) at the lumbar spine. Secondary outcomes included BMD changes at the total hip and femoral neck, changes in bone turnover markers, and adverse events. Propensity score matching was employed to assemble patient groups with similar baseline characteristics. Sixty-nine patients each received either denosumab or romosozumab for 12 months. The mean 12-month percentage change from baseline in lumbar spine BMD was 7.2% in the denosumab group and 12.5% in the romosozumab group, indicating a significant difference between the groups. The percentage changes in BMD at both the total hip and femoral neck were also significantly higher at 12 months in the romosozumab group than in the denosumab group. In denosumab patients, bone formation and bone resorption markers were significantly decreased at 6 and 12 months from baseline. In the romosozumab group, the bone formation marker was significantly increased at 6 months and then returned to baseline, while the bone resorption marker was significantly decreased at both time points. Adverse events were few and predominantly minor in both groups, with no remarkable difference in the incidence of new vertebral fractures. Romosozumab showed a higher potential for improving BMD than denosumab in this clinical study of postmenopausal osteoporosis patient treatment.

Highlights

  • Twelve (17.4%) and 13 (18.8%) subjects had a history of prior non-vertebral fracture in the denosumab group and romosozumab group, respectively

  • Twenty-seven (39.1%) denosumab patients and 20 (29.0%) romosozumab patients had some kind of osteoporosis treatment history and had been switched to Scientific Reports | (2021) 11:11801 |

  • Using a propensity score-matching cohort design, the present study found that the increasing rates of lumbar spine, total hip, and femoral neck BMD were significantly higher with romosozumab than with denosumab after a treatment period of 12 months, with few serious adverse effects for either drug

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Summary

Introduction

Age (years, mean ± SD) BMI (kg/m2) T-score Lumbar spine Total hip Femoral neck Prior vertebral fracture, n (%) Prior non-vertebral fracture, n (%) History of prior treatment, n (%) Naïve Switch Concomitant use of active vitamin D, n (%) PINP (μg/L, median) TRACP-5b (mU/dL, median) Serum albumin (g/dL) Serum-corrected Ca (mg/dL) eGFR (mL/min/1.73 m­ 2) 25OHD (ng/mL)

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