Efficacy of Denosumab for Control of Bone Mineral Density and Microarchitecture in Postmenopausal Women with Osteoporosis: A One-Year Experience

Abstract

ABSTRACTDenosumab is a fully human monoclonal antibody targeting the receptor activator of nuclear factor-κB 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® (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® 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.