Quelle est la place du romosozumab dans le traitement de l’ostéoporose chez la femme ménopausée ?

Details

Supervisors

Boutsen, Yves

Faculty

Faculté de pharmacie et des sciences biomédicales

Degree label

Master [120] en sciences pharmaceutiques, à finalité spécialisée

Abstract

enSince its marketing authorization in 2019, romosozumab has been indicated for postmenopausal women at high to very high risk of fracture. The FRAME study was among the first to demonstrate its efficacy, showing a significant reduction in the incidence of vertebral fractures compared with placebo after an initial 12-month treatment period, followed in both groups by subsequent therapy with denosumab. Subsequently, the ARCH trial compared romosozumab with alendronate in women at very high fracture risk, highlighting the benefit of a treatment strategy that introduced romosozumab as the initial therapeutic phase, resulting in superior reductions in both vertebral and non-vertebral fractures. Additional studies have further supported the value of sequential treatment strategies incorporating romosozumab as first-line therapy, particularly in postmenopausal women without prior fractures but with low bone mineral density and an elevated fracture risk. Based on these findings, clinical guidelines have defined a specific role for romosozumab, primarily reserving its use for postmenopausal women at high or very high risk of fracture. Despite this clear positioning in recommendations, its use in routine clinical practice remains limited. Factors such as cardiovascular safety concerns, treatment cost, and therapeutic inertia contribute to the gap between guideline recommendations and real-world practice. In this context, pharmacists play a crucial role by providing patient education, ensuring treatment safety, and supporting patient follow-up, thereby helping to promote the appropriate and optimized use of romosozumab.