Article title efficacy and safety of romosozumab in postmenopausal women with osteoporosis previously treated with antiresorptive drugs: a prospective observational study and literature review
Abstract
Objectives: The number of patients receiving long-term antiresorptive drugs for postmenopausal osteoporosis is increasing worldwide. However, there is limited evidence on when and how to discontinue or switch these drugs. This study evaluated the efficacy of romosozumab in women who had been treated with antiresorptive drugs for over three years.
Methods: This was a prospective observational non-randomized study analyzing patients with postmenopausal osteoporosis, which was registered in the jRCT (No. 1051210070). Postmenopausal women with lumbar and femoral neck bone mineral density (BMD) below -2.5 SD, as measured by dual-energy x-ray absorptiometry (DXA), despite more than 36 months of antiresorptive treatment, were recruited. They received romosozumab along with calcium and active vitamin D supplementation for 12 months. BMD and bone turnover markers, including serum P1NP and I-CTP, were periodically monitored.
Results: Twenty-one patients (median age: 73 years) were observed for a median of 833 days. Baseline BMD was 0.77 g/cm² at the lumbar spine (T-score: -2.0) and 0.49 g/cm² at the femoral neck (T-score: -2.8). After 12 months, lumbar BMD significantly increased by 6.2% (P P = 0.46). P1NP and I-CTP levels significantly increased by 455.8% and 30.3%, respectively (P < 0.001). One patient developed periodontitis and a vertebral fracture. Multiple regression analysis identified baseline BMD and P1NP values as significant predictors of lumbar BMD changes.
Conclusion:…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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