Clinical characteristics and response to Romosozumab treatment in patients at very high risk of fracture: an observational study in the Healthcare Area of A Coruña.
Authorship
A.S.O.
Bachelor of Medicine
A.S.O.
Bachelor of Medicine
Defense date
02.06.2026 09:00
02.06.2026 09:00
Summary
Introduction: Osteoporosis is associated with an increased risk of fracture. Patients at very high risk constitute a therapeutic priority, as these fractures impair quality of life and generate a substantial economic impact on the healthcare system. However, information on the characteristics of this population and on the effectiveness of new anabolic agents in Spain remains limited. Objective: To describe the epidemiological, demographic, and clinical characteristics of patients stratified as very high risk of fracture in the Healthcare Area of A Coruña. To assess, in a subgroup of the sample, the effectiveness and safety of Romosozumab in a real-world clinical setting. Methods: Observational, retrospective, single-center study including 75 patients classified as very high fracture risk according to SEIOMM guidelines. Demographic variables, risk factors, comorbidities, densitometric values, biochemical parameters, fracture history, and prior treatments were collected. In a subgroup of 16 patients who completed 12 months of Romosozumab, changes in lumbar and femoral T-scores were analyzed. Results: The cohort included 75 patients, mostly women (93,3%), with a mean age of 73 years, a high prevalence of vertebral fractures (58%) and hip fractures (30%), and markedly reduced baseline T-scores (lumbar -3.3; femoral -2.9). In the subgroup of 16 patients treated with Romosozumab for 12 months, a significant improvement in T-score was observed: +0.8 points in the lumbar spine (p menor que 0.001) and +0.2 in the femoral neck (p = 0.019). Two fractures (patella and hip) occurred during treatment, and no serious adverse events were reported. Conclusion: The population classified as very high fracture risk is predominantly female, elderly, with a high fracture burden and multiple comorbidities. Romosozumab appears to be an effective and safe therapy in a real-world clinical practice setting.
Introduction: Osteoporosis is associated with an increased risk of fracture. Patients at very high risk constitute a therapeutic priority, as these fractures impair quality of life and generate a substantial economic impact on the healthcare system. However, information on the characteristics of this population and on the effectiveness of new anabolic agents in Spain remains limited. Objective: To describe the epidemiological, demographic, and clinical characteristics of patients stratified as very high risk of fracture in the Healthcare Area of A Coruña. To assess, in a subgroup of the sample, the effectiveness and safety of Romosozumab in a real-world clinical setting. Methods: Observational, retrospective, single-center study including 75 patients classified as very high fracture risk according to SEIOMM guidelines. Demographic variables, risk factors, comorbidities, densitometric values, biochemical parameters, fracture history, and prior treatments were collected. In a subgroup of 16 patients who completed 12 months of Romosozumab, changes in lumbar and femoral T-scores were analyzed. Results: The cohort included 75 patients, mostly women (93,3%), with a mean age of 73 years, a high prevalence of vertebral fractures (58%) and hip fractures (30%), and markedly reduced baseline T-scores (lumbar -3.3; femoral -2.9). In the subgroup of 16 patients treated with Romosozumab for 12 months, a significant improvement in T-score was observed: +0.8 points in the lumbar spine (p menor que 0.001) and +0.2 in the femoral neck (p = 0.019). Two fractures (patella and hip) occurred during treatment, and no serious adverse events were reported. Conclusion: The population classified as very high fracture risk is predominantly female, elderly, with a high fracture burden and multiple comorbidities. Romosozumab appears to be an effective and safe therapy in a real-world clinical practice setting.
Direction
Suárez Quintanilla, Juan Antonio (Tutorships)
Seoane Romero, Javier (Co-tutorships)
Suárez Quintanilla, Juan Antonio (Tutorships)
Seoane Romero, Javier (Co-tutorships)
Court
LAREU HUIDOBRO, MARIA VICTORIA (Chairman)
SAMPAYO MONTENEGRO, MARIA VICTORIA (Secretary)
CAICEDO VALDES, DIEGO JESUS (Member)
LAREU HUIDOBRO, MARIA VICTORIA (Chairman)
SAMPAYO MONTENEGRO, MARIA VICTORIA (Secretary)
CAICEDO VALDES, DIEGO JESUS (Member)