Clinical Medicine Reviews in Women's Health

Objective: Denosumab, a fully human monoclonal antibody, is an antiresorptive drug in a late-stage of clinical development that neutralizes receptor activator of nuclear factor κB ligand (RANKL), thereby inhibiting osteoclast-mediated bone resorption. The purpose of this paper was to discuss the antifracture efficacy and safety of the subcutaneous administration of denosumab for the treatment of postmenopausal osteoporosis.

Methods: PubMed was searched and strictly conducted randomized controlled trials (RCTs) regarding the effect of denosumab on skeletal health in postmenopausal women were identified.

Results: The results of RCTs showed that a single subcutaneous dose of denosumab rapidly and profoundly reduced bone resorption and sustained (up to 6 months) this effect in postmenopausal women. Denosumab (60 mg, every 6 months) resulted in a sustained decrease in bone turnover, a rapid increase in bone mineral density (BMD), and an improvement of geometric parameters associated with bending and axial strength and cortical stability at purely cortical and mixed cortical/trabecular sites of the proximal femur in postmenopausal women with a low BMD. Denosumab (60 mg every 6 months) reduced the 3-year incidence of vertebral, nonvertebral, and hip fractures (Hazard ratios: 0.32, 0.80, and 0.60, respectively) in postmenopausal women with osteoporosis. Denosumab was well tolerated, and no related severe adverse events were observed.

Conclusions: The subcutaneous administration of denosumab every six months effectively decreased bone resorption, increased the BMD, and reduced the risk of vertebral, nonvertebral, and hip fractures in postmenopausal women. Denosumab offers an emerging option for the treatment of postmenopausal osteoporosis.