Beneficial effects of switching to denosumab from bisphosphonates or selective estrogen receptor modulators in postmenopausal women with type 2 diabetes and osteopenia/osteoporosis

Arina Miyoshi, Hiraku Kameda, So Nagai, Akinobu Nakamura, Aika Miya, Takahiro Takase, Tatsuya Atsumi, Hideaki Miyoshi, Arina Miyoshi, Hiraku Kameda, So Nagai, Akinobu Nakamura, Aika Miya, Takahiro Takase, Tatsuya Atsumi, Hideaki Miyoshi

Abstract

Aims/introduction: Patients with type 2 diabetes mellitus have a higher bone fracture risk than patients without diabetes. Although denosumab (Dmab) is a potent bone resorption inhibitor, its efficacy in patients with type 2 diabetes mellitus 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 type 2 diabetes mellitus patients.

Materials and methods: This was a three medical institutions, prospective, observational study for postmenopausal patients with type 2 diabetes mellitus whose T-score of femoral neck or lumbar spine bone mineral density was under -1.0 standard deviation, even after >6 months of BP or SERM administration. After obtaining consent, participants were treated for 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 bone mineral density and bone metabolism marker levels were evaluated after 6 months.

Results: A total of 48 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 were 71 ± 8 years and 7.2 ± 0.9%, respectively. In the SERM-Dmab group, lumbar spine bone mineral density 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 type 2 diabetes mellitus patients.

Keywords: Denosumab; Osteoporosis; Type 2 diabetes.

Conflict of interest statement

AN, TA and HM have received honoraria for lectures and research funding from organizations as described below. AN obtained research support from Mitsubishi Tanabe Pharma, Daiichi Sankyo, MSD, Novo Nordisk Pharma, Novartis Pharma, AstraZeneca, LifeScan Japan and Taisho Toyama Pharmaceutical. TA received honoraria for lectures from Mitsubishi Tanabe Pharma Co., Chugai Pharmaceutical Co., Ltd., Astellas Pharma Inc., Takeda Pharmaceutical Co., Ltd., Pfizer Inc., AbbVie Inc., UCB Japan Co. Ltd. and Eli Lilly Japan. HK received basic research funding from Astellas Pharma Inc., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo, Otsuka Pharmaceutical Co., Ltd., Eisai Co., Ltd., Bristol‐Myers Squibb Co., Alexion Pharmaceuticals, Inc., UCB Japan Co. Ltd., Eli Lilly Japan K.K. and Gilead Sciences, Inc. HM received honoraria for lectures from Astellas Pharma Inc., Dainippon Pharma Co., Eli Lilly, Mitsubishi Tanabe Pharma Co., MSD, Novartis Pharma, Novo Nordisk Pharma, Kowa Pharmaceutical Co. Ltd., Nippon Boehringer Ingelheim Co., Ono Pharmaceutical Co. Ltd. and Sanofi, and received research funding from Astellas Pharma Inc., Daiichi Sankyo, Dainippon Pharma Co., Eli Lilly, Mitsubishi Tanabe Pharma Co., Novo Nordisk Pharma, Kowa Pharmaceutical Co., Abbott Japan Co., Nippon Boehringer Ingelheim Co., Ono Pharmaceutical Co. Ltd. and Taisho Toyama Pharmaceutical Co. Ltd. The other authors declare no conflict of interest.

© 2020 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Figures

Figure 1
Figure 1
Flow diagram of the study. BP, bisphosphonate; Dmab, denosumab; SERM, selective estrogen receptor modulator; T2DM, type 2 diabetes mellitus; VitD, vitamin D.

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Source: PubMed

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