Effectiveness of Romosozumab in Patients with Osteoporosis at High Fracture Risk: a Japanese Real-world Study

Overview

Journal J Bone Miner Metab

Specialty Endocrinology

Date 2023 Dec 12

PMID 38086988

Authors

Akimitsu Miyauchi

Etsuro Hamaya

Junichiro Shimauchi

Yoko Yoshinaga

Kiyoshi Nishi

Affiliations

Soon will be listed here.

Abstract

Introduction: To describe the real-world use of romosozumab in Japan, we conducted a chart review of > 1000 Japanese patients with osteoporosis (OP) at high risk of fracture, across multiple medical institutions.

Materials And Methods: Treatment-naïve and prior OP-treatment patients who received romosozumab for 12 months followed by ≥ 6 months of sequential OP treatment were included. The primary objective described the baseline demographics and clinical characteristics; secondary objectives evaluated changes in bone mineral density (BMD) and bone turnover markers in all patients and effectiveness of romosozumab in a sub-group of treatment-naïve patients using the fracture risk assessment tool (FRAX).

Results: Of the 1027 patients (92.4% female), 45.0% were treatment-naïve. The mean ± SD age of treatment-naïve versus prior OP-treatment patients was 76.8 ± 8.5 and 77.1 ± 8.5 years. The most frequent prior OP treatment was bisphosphonates (45.0%). Romosozumab treatment for 12 months increased BMD at the lumbar spine in all groups; the median percent change from baseline in lumbar spine BMD was higher in the treatment-naïve (13.4%) versus prior OP-treatment group (bisphosphonates [9.2%], teriparatide [11.3%], denosumab [DMAb, 4.5%]). DMAb, bisphosphonates, or teriparatide after romosozumab maintained the BMD gains at all skeletal sites at month 18 in treatment-naïve patients. Most treatment-naïve patients were at high risk of fracture, BMD increased consistently with romosozumab regardless of the baseline fracture risk assessed by FRAX.

Conclusion: This large-scale, multicenter chart review provides clinically relevant insights into the profiles of patients initiating romosozumab, effectiveness of real-world romosozumab use, and sequential therapy in Japanese patients at high risk of fracture.

Citing Articles

Sequential and combination therapy with romosozumab.

Kobayakawa T J Bone Miner Metab. 2025; .

PMID: 40024934 DOI: 10.1007/s00774-025-01590-2.

A practical approach for anabolic treatment of bone fragility with romosozumab.

Cianferotti L, Cipriani C, Palermo A, Viapiana O, Zavatta G, Mazziotti G J Endocrinol Invest. 2024; 47(11):2649-2662.

PMID: 38789679 DOI: 10.1007/s40618-024-02395-2.

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