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학술저널
저자정보
임수 (서울대학교) 김경민 (서울대학교) 김신곤 (고려대학교) 김두만 (한림대학교) 우정택 (경희대학교) 정춘희 (연세대학교) 고경수 (인제대학교) 박정현 (인제대학교) 박용수 (한양대학교) 김상진 (순천향대학교) 장학철 (서울대학교) 최동섭 (고려대학교)
저널정보
대한당뇨병학회 Diabetes and Metabolism Journal Diabetes and Metabolism Journal Vol.41 No.5
발행연도
2017.1
수록면
377 - 385 (9page)

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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.

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