Introduction: Denosumab, a fully human monoclonal antibody to RANK ligand, effectively reduces bone resorption by inhibiting RANK-L binding to RANK. We aimed to evaluate the efficacy of denosumab in post-menopausal women, by monitoring the evolution of different parameters of bone health: T-score, morphometry, osteocalcin and β-Ctx.
Methods: A 34 women with severe postmenopausal osteoporosis, characterized by multiple vertebral fractures were studied. At baseline, hip and spine T-score were measured, by dual energy X-ray absorptiometry (DXA, Hologic) and fulfilled WHO criteria for osteoporosis. At baseline and following a 12-month treatment with Denosumab, all patients underwent morphometry, in order to investigate the prevalence of vertebral fractures during treatment, and measurement of bone metabolism parameters (serum calcium, osteocalcin, and β-Ctx).
Results: At the end of the 12 months, T-score raised at the lumbar level (−2.0±0.5 at baseline and −1.7±0.8 after 12 months, P=0.05, Wilcoxons test) and significantly increased at the hip level (−3.4±0.8 at the baseline and −2.7±1.2 after 12 months, P=0.02, Wilcoxons test).
Serum calcium, osteocalcin, and β-Ctx were within the normal range and no new vertebral fractures were observed, after 12 months of therapy with Denosumab.
Conclusion: Our preliminary results confirm literature data, showing a significant efficacy of Denosumab in the treatment of post-menopausal osteoporosis. The observation of the statistically significant increase of T-score at the hip level, and the absence of incident vertebral fractures, although very promising, requires further data from long term follow-up.
17 May 2014 - 20 May 2014