EFFICACY OF DENOSUMAB FOR CONTROL OF BONE MINERAL DENSITY AND MICROARCHITECTURE IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS: A ONE-YEAR EXPERIENCE

Denosumab is a fully human monoclonal antibody targeting the receptor activator of nuclear factor-kappa B ligand (RANKL) and thus, inhibiting the osteoclast differentiation, activation and survival. Due to its specific mode of action, denosumab is already successfully used as a new targeted therapy of women with low bone mineral density (BMD) resulting from postmenopausal osteoporosis (PMO). The aim of this one-year clinical observational study was to evaluate the therapeutic efficacy and safety profile of denosumab in 36 women with PMO. Denosumab was, administered as a subcutaneous injection of 60 mg once per 6 months. The therapeutic efficacy of denosumab was assessed on the basis of BMD, trabecular bone score (TBS) and fracture risk based on FRAX (R) (WHO Fracture Risk Assessment tool). Treatment with denosumab resulted in an increase in BMD by 3.9% at the lumbar spine and by 1.3% at the total hip (as compared to the baseline BMD values) with corresponding improvement of the T-score of the lumbar spine of 13.8% and 4.5% of total hip, respectively TBS is a new texture measurement that correlates with the quality of bone microarchitecture. At month 12, the TBS appeared to be significantly increased by 1.7% as compared to its baseline mean value. The risk of major osteoporotic fracture and hip fracture assessed by FRAX (R) was reduced by 13.3% and 38.4%, respectively These data, representing the local clinical experience, suggest that denosumab might be used as an effective treatment of PMO.