Abstract：
BACKGROUND: Observational studies show inverse associations between serum 25-hydroxyvitamin D concentrations and sarcopenia incidence; however, it remains unclear whether treatment with vitamin D prevents its development. We aimed to assess whether treatment with active vitamin D (eldecalcitol [0·75 μg per day]) can reduce the development of sarcopenia among adults with prediabetes.
METHODS: This randomised, double-blind, placebo-controlled, multicenter trial as an ancillary study was conducted at 32 clinics and hospital sites in Japan. Participants were assigned (1:1) by using a central randomisation method in which a randomisation list was made for each hospital separately using a stratified permuted block procedure. The primary endpoint was sarcopenia incidence during 3 years in the intention-to-treat population defined as weak handgrip strength (<28 kg for men and <18 kg for women) and low appendicular skeletal muscle index (<7·0 kg/m2 for men and <5·7 kg/m2 for women in bioelectrical impedance analysis). Although the usual criterion of hypercalcaemia was 10·4 mg/dL (2·6 mmol/L) or higher, hypercalcaemia that was enough to discontinue the study was defined as 11·0 mg/dL or higher. This study is registered with the UMIN clinical trials registry, UMIN000005394.
RESULTS: A total of 1094 participants (548 in the eldecalcitol group and 546 in the placebo group; 44·2% [484 of 1094] women; mean age 60·8 [SD 9·2] years) were followed up for a median of 2·9 (IQR 2·8-3·0) years. Eldecalcitol treatment as compared with placebo showed statistically significant preventive effect on sarcopenia incidence (25 [4·6%] of 548 participants in the eldecalcitol group and 48 [8·8%] of 546 participants in the placebo group; hazard ratio 0·51; 95% CI 0·31 to 0·83; p=0·0065). The incidence of adverse events did not differ between the two groups.
CONCLUSIONS: We found that treatment with eldecalcitol has the potential to prevent the onset of sarcopenia among people with prediabetes via increasing skeletal muscle volume and strength, which might lead to a substantial risk reduction of falls.
BACKGROUND: Kitakyushu Medical Association.
UNASSIGNED: For the Japanese translation of the abstract see Supplementary Materials section.
METHODS: This randomised, double-blind, placebo-controlled, multicenter trial as an ancillary study was conducted at 32 clinics and hospital sites in Japan. Participants were assigned (1:1) by using a central randomisation method in which a randomisation list was made for each hospital separately using a stratified permuted block procedure. The primary endpoint was sarcopenia incidence during 3 years in the intention-to-treat population defined as weak handgrip strength (<28 kg for men and <18 kg for women) and low appendicular skeletal muscle index (<7·0 kg/m2 for men and <5·7 kg/m2 for women in bioelectrical impedance analysis). Although the usual criterion of hypercalcaemia was 10·4 mg/dL (2·6 mmol/L) or higher, hypercalcaemia that was enough to discontinue the study was defined as 11·0 mg/dL or higher. This study is registered with the UMIN clinical trials registry, UMIN000005394.
RESULTS: A total of 1094 participants (548 in the eldecalcitol group and 546 in the placebo group; 44·2% [484 of 1094] women; mean age 60·8 [SD 9·2] years) were followed up for a median of 2·9 (IQR 2·8-3·0) years. Eldecalcitol treatment as compared with placebo showed statistically significant preventive effect on sarcopenia incidence (25 [4·6%] of 548 participants in the eldecalcitol group and 48 [8·8%] of 546 participants in the placebo group; hazard ratio 0·51; 95% CI 0·31 to 0·83; p=0·0065). The incidence of adverse events did not differ between the two groups.
CONCLUSIONS: We found that treatment with eldecalcitol has the potential to prevent the onset of sarcopenia among people with prediabetes via increasing skeletal muscle volume and strength, which might lead to a substantial risk reduction of falls.
BACKGROUND: Kitakyushu Medical Association.
UNASSIGNED: For the Japanese translation of the abstract see Supplementary Materials section.
摘要：
背景：观察性研究表明，血清25-羟维生素D浓度与少肌症发病率呈负相关；然而，目前尚不清楚维生素D治疗是否会阻止其发展。我们旨在评估活性维生素D（eldecalcitol[0·75μg/天]）治疗是否可以减少糖尿病前期成人中肌肉减少症的发展。
方法：这是随机的，双盲,安慰剂对照,多中心试验作为辅助研究在日本的32家诊所和医院进行.通过使用中央随机化方法对参与者进行分配（1：1），其中使用分层置换区组程序分别为每家医院制作随机化列表。主要终点是意向治疗人群中3年内的肌肉减少症发生率，定义为握力弱（男性<28kg，女性<18kg）和阑尾骨骼肌指数低（生物电阻抗分析中男性<7·0kg/m2，女性<5·7kg/m2）。尽管高钙血症的通常标准是10·4mg/dL（2·6mmol/L）或更高，足以中止研究的高钙血症定义为11·0mg/dL或更高.本研究已在UMIN临床试验注册中心注册，UMIN000005394。
结果：总共1094名参与者（依替骨化醇组548名，安慰剂组546名；44·2％[1094中的484名]女性；平均年龄60·8[SD9·2]岁）进行了随访，中位随访时间为2·9（IQR2·8-3·0）年。与安慰剂相比，Eldecalcitol治疗对肌肉减少症发生率具有统计学意义（eldecalcitol组548名参与者中有25[4·6％]，安慰剂组546名参与者中有48名[8·8％]；风险比0·51；95％CI0·31至0·83；p=0·0065）。两组的不良事件发生率无差异。
结论：我们发现，使用eldecalcitol治疗糖尿病前期患者有可能通过增加骨骼肌体积和力量来预防肌肉减少症的发作。这可能会导致跌倒风险的大幅降低。
背景：北九州医学会。
■有关摘要的日语翻译，请参见补充材料部分。
方法：这是随机的，双盲,安慰剂对照,多中心试验作为辅助研究在日本的32家诊所和医院进行.通过使用中央随机化方法对参与者进行分配（1：1），其中使用分层置换区组程序分别为每家医院制作随机化列表。主要终点是意向治疗人群中3年内的肌肉减少症发生率，定义为握力弱（男性<28kg，女性<18kg）和阑尾骨骼肌指数低（生物电阻抗分析中男性<7·0kg/m2，女性<5·7kg/m2）。尽管高钙血症的通常标准是10·4mg/dL（2·6mmol/L）或更高，足以中止研究的高钙血症定义为11·0mg/dL或更高.本研究已在UMIN临床试验注册中心注册，UMIN000005394。
结果：总共1094名参与者（依替骨化醇组548名，安慰剂组546名；44·2％[1094中的484名]女性；平均年龄60·8[SD9·2]岁）进行了随访，中位随访时间为2·9（IQR2·8-3·0）年。与安慰剂相比，Eldecalcitol治疗对肌肉减少症发生率具有统计学意义（eldecalcitol组548名参与者中有25[4·6％]，安慰剂组546名参与者中有48名[8·8％]；风险比0·51；95％CI0·31至0·83；p=0·0065）。两组的不良事件发生率无差异。
结论：我们发现，使用eldecalcitol治疗糖尿病前期患者有可能通过增加骨骼肌体积和力量来预防肌肉减少症的发作。这可能会导致跌倒风险的大幅降低。
背景：北九州医学会。
■有关摘要的日语翻译，请参见补充材料部分。
