Diabetes Metab J.  2017 Oct;41(5):377-385. 10.4093/dmj.2017.41.5.377.

Effects of Lobeglitazone, a Novel Thiazolidinedione, on Bone Mineral Density in Patients with Type 2 Diabetes Mellitus over 52 Weeks

• Lim S
• Kim KM
• Kim SG
• Kim DM
• Woo JT
• Chung CH
• Ko KS
• Park JH
• Park Y
• Kim SJ
• Jang HC
• Choi DS

• KMID: 2392481
• DOI: http://doi.org/10.4093/dmj.2017.41.5.377

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.

Keyword

Bone density; Diabetes mellitus, type 2; Lobeglitazone; Thiazolidinediones

MeSH Terms

Absorptiometry, Photon
Bone Density*
Diabetes Mellitus, Type 2*
Double-Blind Method
Femur Neck
Hip
Humans
Thiazolidinediones
Thiazolidinediones

Figure

• 

  Fig. 1 Mean percentage of changes in bone mineral density (BMD) during the study period for the femur neck and total hip in (A, B) all subjects, (C, D) men, and (E, F) women.

• 

  Fig. 2 Mean percentage changes in bone mineral density (BMD) for the (A) femur neck and (B) total hip during the double-blinded and open-labeled phases. NS, not significant.

• 

  Fig. 3 Ratios of subjects who showed significant bone loss at the (A) femur neck and (B) total hip during the double-blinded and open-labeled phases. BMD, bone mineral density; NS, not significant.

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