J Diabetes Investig doi: 10.1111/jdi.13458.
Aims/introduction: Patients with type 2 diabetes (T2DM) have a higher bone fracture risk than non-diabetic patients. Although denosumab (Dmab) is a potent bone resorption inhibitor, its efficacy in patients with T2DM has not been elucidated. In this study, we investigated the effects of switching to Dmab from bisphosphonates (BP) or a selective estrogen receptor modulator (SERM) in postmenopausal T2DM patients.
Materials and methods: This was a three medical institutions, prospective, observational study for postmenopausal patients with T2DM whose T-score of femoral neck (FN) or lumbar spine (LS) bone mineral density (BMD) was under -1.0 SD even after > 6 months BP or SERM administration. After obtaining consent, participants were treated for the osteopenia/osteoporosis by either continuing BP (BP-BP group) / SERM (SERM-SERM group), or by switching to Dmab (BP-Dmab or SERM-Dmab groups). Changes in BMD and bone metabolism marker levels were evaluated after 6 months.
Results: Forty-eight patients were included in this study, and each group comprised 12 patients. No significant difference existed in baseline characteristics among the groups. The average age and glycated hemoglobin (HbA1c) were 71 ± 8 years and 7.2 ± 0.9%, respectively. In the SERM-Dmab group, LS BMD was significantly increased by 5.0% compared with the SERM-SERM group (p <0.04). Serum bone-specific alkaline phosphatase and tartrate-resistant acid phosphatase 5b were significantly decreased in the BP-Dmab and SERM-Dmab groups compared with the BP-BP and SERM-SERM groups, respectively.
Conclusions: Switching to Dmab from BP or SERM is beneficial to prevent osteoporosis progression in postmenopausal patients with T2DM patients.