Rheumatoid arthritis with fragility fractures
Conditions
Interventions
None listed
Sponsors
Kawasaki Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of new fragility fractures at 104 weeks after switching to romosozumab | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Timing of Fracture Occurrence Incidence of new fragility fractures at 26, 52, and 78 weeks after switching to romosozumab 2. Bone Metabolism and Bone Mass Changes Changes in bone turnover markers (TRAP-5b and total P1NP) at baseline, 52 weeks, and 104 weeks Percentage changes in bone mineral density of the lumbar spine and proximal femur at the same time points 3. Safety Outcomes Incidence of cardiovascular events (myocardial infarction, stroke, etc.) Incidence of osteonecrosis of the jaw Incidence of injection site reactions and hypersensitivity (allergic reactions) Incidence of infections Incidence of malignancies 4. Rheumatoid Arthritis Disease Activity Changes in disease activity assessed by CDAI Changes in antirheumatic medications 5. Comparative Evaluation with Non-RA Osteoporosis Patients Non-RA osteoporosis patients will be used as the control group to evaluate fracture incidence, changes in bone turnover markers, bone mineral density, and safety outcomes after switching to romosozumab. | — |
Countries
Japan
Contacts
Public ContactShunichi Fujita
Kawasaki Medical School Department of Rheumatology
Outcome results
None listed