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Background: Pedicle screw loosening is a major complication following spinal fixation associated with osteoporosis in elderly. However, denosumab is a promising treatment in patients with osteoporosis. The effect of denosumab on pedicle screw fixation is unknown. Therefore, we investigated whether denosumab treatment improves pedicle screw fixation in elderly patients with osteoporosis., Methods: This was a 2-year prospective open-label study. From February 2015 to January 2016, we included 21 patients with postmenopausal osteoporosis who received initial denosumab treatment. At baseline, 12 months, and 24 months, we measured volumetric bone mineral density (BMD) using quantitative computed tomography (QCT) and performed CT-based finite element analysis (FEA). Finite element models of L4 vertebrae were created to analyze the bone strength and screw fixation., Results: BMD increased with denosumab treatment. FEA revealed that both pullout strength of pedicle screws and compression force of the vertebra increased significantly at 12 and 24 months following denosumab treatment. Notably, pullout strength showed a stronger correlation with three-dimensional volumetric BMD around pedicle screw placement assessed by QCT (r = 0.83, at 24 months) than with two-dimensional areal BMD assessed by dual energy X-ray absorptiometry (r = 0.35, at 24 months)., Conclusion: To our knowledge, this is the first study to reveal that denosumab treatment achieved strong pedicle screw fixation with an increase in BMD around the screw assessed by QCT and FEA; therefore, denosumab could be useful for osteoporosis treatment during spinal surgery in elderly patients with osteoporosis.

Discontinuation of denosumab during osteoporosis treatment leads to rapid loss of bone mineral density and induces a bone turnover rebound effect. Previous studies have reported analysis based on dual-energy X-ray absorptiometry scanning (DXA). Here, we report the first case involving analysis of three-dimensional bone mineral density and bone strength, measured by quantitative computed tomography (QCT) after discontinuation of denosumab. An 82-year-old woman who discontinued denosumab because of patient's wish was administered the fifth dose after a gap of 14 months. Her bone mineral density evaluated by DXA and QCT, bone strength, and bone turnover marker levels showed significant rebound phenomenon. The levels of the cortical parameters of the hip were also decreased indicating an increased risk of femoral fractures after denosumab interruption. Our case highlights the increased risk of fractures after discontinuation of denosumab. Therefore, denosumab must be used judiciously without interruption in the dosage schedule., Competing Interests: The authors report no conflicts of interest in this work.

Denosumab is a fully human monoclonal antibody against the receptor activator of nuclear factor-κB ligand (RANKL) that is used for the treatment of osteoporosis. Denosumab-induced hypocalcemia is a rare but important adverse event, which is usually asymptomatic in patients with osteoporosis. It is also known that hypocalcemia is common in patients with bone metastases and severe renal impairment. Here we report a case of symptomatic hypocalcemia following administration of 60 mg of denosumab in a patient with high bone turnover and no renal impairment (estimated glomerular filtration rate [eGFR], 71 mL/min), despite prophylactic oral vitamin D administration. This report supports our observation that there is a risk of protracted and marked denosumab-induced hypocalcemia in patients with high bone turnover, irrespective of their degree of renal impairment., Competing Interests: Disclosure The authors report no conflicts of interest in this work.