Abstract：
BACKGROUND: Bone fragility is a critical issue in the treatment of elderly people with type 2 diabetes (T2D). In the Canagliflozin Cardiovascular Assessment Study, the subjects with T2D who were treated with canagliflozin showed a significant increase in fracture events compared to a placebo group as early as 12 weeks post-initiation. In addition, it has been unclear whether sodium-glucose co-transporter 2 (SGLT2) inhibitors promote bone fragility. We used high-resolution peripheral quantitative computed tomography (HR-pQCT) to prospectively evaluate the short-term effect of the SGLT2 inhibitor luseogliflozin on bone strength and microarchitecture in elderly people with T2D.
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.
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.
摘要：
背景：骨脆性是治疗老年人2型糖尿病（T2D）的关键问题。在Canagliflozin心血管评估研究中，与安慰剂组相比,接受canagliflozin治疗的T2D患者早在开始治疗后12周就显示骨折事件显著增加.此外,目前尚不清楚钠-葡萄糖共转运蛋白2(SGLT2)抑制剂是否促进骨脆性.我们使用高分辨率外周定量计算机断层扫描（HR-pQCT）前瞻性评估SGLT2抑制剂luseogliflozin对T2D老年人骨强度和微结构的短期影响。
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。
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。
