Lim Soo, Kim Kyoung Min, Kim Sin Gon, Kim Doo Man, Woo Jeong Taek, Chung Choon Hee, Ko Kyung Soo, Park Jeong Hyun, Park Yongsoo, Kim Sang Jin, Jang Hak Chul, Choi Dong Seop
Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Diabetes Metab J. 2017 Oct;41(5):377-385. doi: 10.4093/dmj.2017.41.5.377.
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.
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).
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.
Our results indicate that treatment with lobeglitazone 0.5 mg over 52 weeks showed no detrimental effect on the BMD compared to the placebo.
这项多中心、随机、双盲研究的目的是检验新型噻唑烷二酮类药物罗格列酮对2型糖尿病患者骨密度（BMD）变化的影响。
先进行为期24周的双盲阶段，随后是为期28周的开放标签阶段，在此阶段安慰剂组也开始接受罗格列酮治疗。总共170名年龄在34至76岁之间的患者按2:1的比例随机分配，口服0.5毫克罗格列酮或匹配的安慰剂，每日一次。在第24周和研究结束时（第52周）使用双能X线吸收法评估骨密度。
在双盲阶段，两组的股骨颈骨密度均呈下降趋势，但无统计学意义（罗格列酮组和安慰剂组分别为-0.85%±0.36%和-0.78%±0.46%）。两组之间的治疗差异为0.07%，也无统计学意义。此外，与基线值相比，两组全髋骨密度均有轻微、无统计学意义的下降，且两组之间的这些差异也无显著差异。在开放标签阶段，罗格列酮组的股骨颈骨密度进一步下降，但不显著，下降了-0.32%，全髋骨密度下降了-0.60%，与改为接受罗格列酮治疗的原安慰剂组相比，这些变化无显著差异。
我们的结果表明，与安慰剂相比，52周内服用0.5毫克罗格列酮对骨密度没有不利影响。
