The Effects of Bazedoxifene on Bone, Glucose, and Lipid Metabolism in Postmenopausal Women With Type 2 Diabetes: An Exploratory Pilot Study.
BACKGROUND
Selective estrogen receptor modulators (SERMs) decrease homocysteine and cross-linking of pentosidine and reduce low-density lipoprotein cholesterol (LDL-C), and they are expected to improve bone quality and atherosclerosis. Therefore, the potential effects of bazedoxifene on bone (bone resorption, bone formation, and bone quality), as well as on glucose and lipid metabolism markers, were examined in Japanese postmenopausal women with type 2 diabetes mellitus (T2DM).


METHODS
Eligible patients received 20 mg of bazedoxifene tablets once daily and were followed up for 12 weeks. Bone resorption markers including tartrate-resistant acid phosphatase 5b (TRACP-5b), bone formation markers and bone quality markers such as homocysteine and serum pentosidine, total cholesterol (TC), LDL-C, high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), and HbA1c were all measured.


RESULTS
Twenty patients completed this study. All bone resorption markers decreased significantly 4 weeks after bazedoxifene treatment. In particular, TRACP-5b decreased significantly at 12 weeks (median percent change: -20.6%), and the minimum significant change (MSC) achievement rate of TRACP-5b was 65%. Bazedoxifene also decreased bone formation markers. However, bazedoxifene did not improve bone quality markers. LDL-C, HDL-C, and non-HDL-C were decreased, but TG was unchanged. Glucose metabolism was not changed after bazedoxifene treatment. In a subgroup analysis, the group of patients in whom the percent change in TRACP-5b exceeded the MSC had no change in pentosidine levels at 12 weeks. However, in the group of patients in whom the percent change in TRACP-5b did not exceed the MSC, pentosidine levels tended to increase.


CONCLUSIONS
Bazedoxifene may improve bone resorption markers and LDL-C without affecting glucose metabolism in Japanese postmenopausal women with T2DM.
Division of Metabolism and Endocrinology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations Yokohama, 132 Katsura-cho, Sakae-ku, Yokohama, Kanagawa 247-8581, Japan ; Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.
Taishi
T
Yoshii
Division of Metabolism and Endocrinology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations Yokohama, 132 Katsura-cho, Sakae-ku, Yokohama, Kanagawa 247-8581, Japan.
Masayo
M
Yamada
Division of Metabolism and Endocrinology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations Yokohama, 132 Katsura-cho, Sakae-ku, Yokohama, Kanagawa 247-8581, Japan.
Taichi
T
Minami
Division of Metabolism and Endocrinology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations Yokohama, 132 Katsura-cho, Sakae-ku, Yokohama, Kanagawa 247-8581, Japan.
Tetsuji
T
Tsunoda
Division of Metabolism and Endocrinology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations Yokohama, 132 Katsura-cho, Sakae-ku, Yokohama, Kanagawa 247-8581, Japan.
Mayuko
M
Sasaki
Department of Endocrinology and Metabolism, Chigasaki Municipal Hospital, 5-15-1 Motomura, Chigasaki, Kanagawa 253-0042, Japan.
Yoshinobu
Y
Kondo
Department of Endocrinology and Metabolism, Chigasaki Municipal Hospital, 5-15-1 Motomura, Chigasaki, Kanagawa 253-0042, Japan.
Shinobu
S
Satoh
Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.
Yasuo
Y
Terauchi
Bazedoxifene; Bone metabolism; Postmenopausal women; Selective estrogen receptor modulators; Type 2 diabetes mellitus