Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks.
10.4093/dmj.2017.41.5.377
- Author:
Soo LIM
1
;
Kyoung Min KIM
;
Sin Gon KIM
;
Doo Man KIM
;
Jeong Taek WOO
;
Choon Hee CHUNG
;
Kyung Soo KO
;
Jeong Hyun PARK
;
Yongsoo PARK
;
Sang Jin KIM
;
Hak Chul JANG
;
Dong Seop CHOI
Author Information
1. Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
- Publication Type:Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Bone density;
Diabetes mellitus, type 2;
Lobeglitazone;
Thiazolidinediones
- MeSH:
Absorptiometry, Photon;
Bone Density*;
Diabetes Mellitus, Type 2*;
Double-Blind Method;
Femur Neck;
Hip;
Humans;
Thiazolidinediones
- From:Diabetes & Metabolism Journal
2017;41(5):377-385
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND: The aim of this multicenter, randomized, double-blind study was to examine the effect of lobeglitazone, a novel thiazolidinedione, on the changes in bone mineral density (BMD) in patients with type 2 diabetes mellitus. METHODS: A 24-week, double-blinded phase was followed by a 28-week, open-label phase, in which the placebo group also started to receive lobeglitazone. A total of 170 patients aged 34 to 76 years were randomly assigned in a 2:1 ratio to receive lobeglitazone 0.5 mg or a matching placebo orally, once daily. BMD was assessed using dual-energy X-ray absorptiometry at week 24 and at the end of the study (week 52). RESULTS: During the double-blinded phase, the femur neck BMD showed decreasing patterns in both groups, without statistical significance (−0.85%±0.36% and −0.78%±0.46% in the lobeglitazone and placebo groups, respectively). The treatment difference between the groups was 0.07%, which was also not statistically significant. Further, minimal, nonsignificant decreases were observed in both groups in the total hip BMD compared to values at baseline, and these differences also did not significantly differ between the groups. During the open-label phase, the BMD was further decreased, but not significantly, by −0.32% at the femur neck and by −0.60% at the total hip in the lobeglitazone group, and these changes did not significantly differ compared with the original placebo group switched to lobeglitazone. CONCLUSION: Our results indicate that treatment with lobeglitazone 0.5 mg over 52 weeks showed no detrimental effect on the BMD compared to the placebo.
