METHODS: This was a single-center, randomized, open-label, active-controlled pilot trial for ≥ 60-year-old Japanese individuals with T2D without osteoporosis. A total of 22 subjects (seven women and 15 men) were randomly assigned to a Lusefi group (added luseogliflozin 2.5 mg) or a control group (added metformin 500 mg) and treated for 48 weeks. We used the second-generation HR-pQCT (Xtreme CT II®, Scanco Medical, Brüttisellen, Switzerland) before and 48 weeks after the treatment to evaluate the subjects\' bone microarchitecture and estimate their bone strength.
RESULTS: Twenty subjects (Lusefi group, n = 9; control group, n = 11) completed the study, with no fracture events. As the primary outcome, the 48-week changes in the bone strength (stiffness and failure load) estimated by micro-finite element analysis were not significantly different between the groups. As the secondary outcome, the changes in all of the cortical/trabecular microarchitectural parameters at the radius and tibia from baseline to 48 weeks were not significantly different between the groups.
CONCLUSIONS: In the pilot trial, we observed no negative effect of 48-week luseogliflozin treatment on bone microarchitecture or bone strength in elderly people with T2D.
BACKGROUND: UMIN-CTR no. 000036202 and jRCT 071180061.
方法:这是一个单中心,随机化,开放标签,对≥60岁的日本T2D患者无骨质疏松症患者进行主动对照试验。共有22名受试者(7名女性和15名男性)被随机分配到Lusefi组(添加luseogliflozin2.5mg)或对照组(添加二甲双胍500mg),治疗48周。我们使用了第二代HR-pQCT(XtremeCTII®,ScancoMedical,Brüttisellen,瑞士)治疗前和治疗后48周,以评估受试者的骨微结构并估计其骨强度。
结果:20名受试者(Lusefi组,n=9;对照组,n=11)完成研究,没有骨折事件。作为主要结果,通过微有限元分析估算的骨强度(刚度和失效载荷)的48周变化在组间无显著差异.作为次要结果,从基线到48周,桡骨和胫骨的所有皮质/小梁微结构参数的变化在组间无显著差异.
结论:在试点试验中,我们观察到48周luseogliflozin治疗对患有T2D的老年人的骨微结构或骨强度没有负面影响.
背景:UMIN-CTR号。000036202和JRCT071180061。