Background/Purpose: Osteoporosis is a common complication of glucocorticoid therapy, contributing to significant morbidity especially in patients receiving very high doses of glucocorticoid (GC). There have been insufficient data supporting the antifracture efficacy of denosumab in glucocorticoid-induced osteoporosis, and its efficacy in patients receiving very high doses of GC has not been demonstrated so far. We aimed to verify the efficacy and safety of denosumab in patients receiving very high doses of GC.

Methods: We retrospectively reviewed the clinical data of patients with connective tissue diseases initiating very high-dose GC treatment (prednisolone ≧0.8 mg/kg/day) in our hospital from January 2012 to April 2017. We recruited patients initiating osteoporosis prophylaxis either with denosumab or bisphosphonates within six months after the initiation of GC treatment. We compared the risk of clinical osteoporotic fractures and safety profiles between the denosumab group and the bisphosphonate group.

Results: Among patients initiating very high-dose GC treatment during January 2012 to April 2017, 56 patients (median age: 65 years old) received osteoporosis prophylaxis with bisphosphonates and 16 patients (median age: 69 years old) received osteoporosis prophylaxis with denosumab. The bone mineral density of the femoral neck at baseline was 0.87 ± 0.23 g/cm² in the denosumab group and 0.79 ± 0.11 g/cm² in the bisphosphonate group (p>0.05). No patients suffered clinical osteoporotic fractures in the denosumab group (median observation period: 21.5 months), while seven patients suffered clinical osteoporotic fractures in the bisphosphonate group (median observation period: 30.5 months). The risk of clinical osteoporotic fractures was similar between two groups (p=0.21). Avascular necrosis of the femoral head (AVNFH) occurred in eight patients (14%) in the bisphosphonate group, while no patients suffered AVNFH in the denosumab group. Osteonecrosis of the jaw occurred in one (6%) patient in the denosumab group and one (2%) patient in the bisphosphonate group. Transient hypocalcemia occurred in three (19%) patients in the denosumab group and six (11%) patients in the bisphosphonate group, all of which resolved without any intervention.

Conclusion: Denosumab is a useful option for osteoporosis prophylaxis in patients initiating very high-dose GC treatment, having at least equivalent efficacy and safety with bisphosphonates.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-efficacy-of-denosumab-for-prevention-of-osteoporotic-fractures-in-patients-with-connective-tissue-diseases-receiving-very-high-doses-of-glucocorticoid/