Tokyo, Feb. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060596) titled 'A Study to Evaluate the Effectiveness and Safety of Switching to Romosozumab in Patients with Rheumatoid Arthritis and Fragility Fractures' on Feb. 19.

Study Type: Observational

Primary Sponsor: Institute - Kawasaki Medical School

Condition: Condition - Rheumatoid arthritis with fragility fractures Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the effectiveness and safety of switching from antiresorptive agents to romosozumab in patients with rheumatoid arthritis and a history of fragility fractures. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 50 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Eligible patients must meet all of the following criteria: 1. Male or female patients aged 50 years or older 2. Patients diagnosed with rheumatoid arthritis according to the ACR/EULAR classification criteria, or patients with non-rheumatoid arthritis osteoporosis 3. Patients who meet the diagnostic criteria for osteoporosis and have a history of fragility fractures 4. Patients who have been receiving antiresorptive therapy (denosumab or bisphosphonates) for at least 6 months 5. Patients who have provided written informed consent after receiving sufficient explanation of the study 6. Patients who are able to attend regular outpatient visits and undergo scheduled evaluations during the study period Key exclusion criteria - Patients meeting any of the following criteria will be excluded from this study: 1. Patients with a history of treatment with bone-forming agents (teriparatide, abaloparatide, etc.) 2. Patients with connective tissue diseases other than rheumatoid arthritis (in the non-rheumatoid arthritis group) 3. Patients currently receiving denosumab or bisphosphonates as bone-modifying agents for the prevention or treatment of skeletal-related events associated with malignancy 4. Patients with a history of severe cardiovascular events, such as myocardial infarction or stroke, within one year prior to enrollment 5. Patients with a history of osteonecrosis of the jaw or active jaw lesions 6. Patients judged by the principal investigator to be inappropriate for participation in this study Target Size - 400

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 01 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069304

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