Subject    :    [2017 Oct;41(5)] Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks
Writer KDA
Date 2018-12-03 18:28:34 Hit 1,901
   
Diabetes Metab J. 2017 Oct;41(5):377-385. English.
Published online Oct 24, 2017.  https://doi.org/10.4093/dmj.2017.41.5.377 
Copyright © 2017 Korean Diabetes Association
   
Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks
Soo Lim,1,* Kyoung Min Kim,1,* Sin Gon Kim,2 Doo Man Kim,3 Jeong-Taek Woo,4 Choon Hee Chung,5Kyung Soo Ko,6 Jeong Hyun Park,7 Yongsoo Park,8,9 Sang Jin Kim,10 Hak Chul Jang,1 and Dong Seop Choi2
1Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
2Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
3Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
4Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University School of Medicine, Seoul, Korea.
5Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea.
6Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.
7Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea,
8Kosair Children's Hospital Research Institute, University of Louisville, Louisville, KY, USA.
9Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
10Department of Internal Medicine, Soon Chun Hyang University Cheonan Hospital, Soon Chun Hyang University College of Medicine, Cheonan, Korea.

Corresponding author: Dong Seop Choi. Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, 73 Inchon-ro, Seongbuk-gu, Seoul 02841, Korea. Email: cdongs@kumc.or.kr

 

*Soo Lim and Kyoung Min Kim contributed equally to this study as first authors.
 
Received March 08, 2017; Accepted May 05, 2017.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.



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.

   
Keywords:
Bone densityDiabetes mellitus, type 2LobeglitazoneThiazolidinediones

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