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Teriparatide (recombinant human parathyroid hormone [1-34]) increases foot bone remodeling in diabetic chronic Charcot neuroarthropathy: a randomized double-blind placebo-controlled study.

Abstract：

BACKGROUND:Currently, there is no consensus regarding the medical treatment of chronic Charcot neuroarthropathy (CN) of foot, except for effective off-loading. Because tarsal bones are predominantly trabecular, teriparatide may improve the macroarchitecture of foot bones in chronic CN. METHODS:People with diabetes and chronic CN were randomized to receive either 20 μg teriparatide or placebo subcutaneous daily for 12 months. Thirty-eight patients were screened and data were analyzed for 20. The maximum standardized uptake (SUVmax ) value of 18 F-FDG PET/CT the region of interest, bone turnover markers and foot bone mineral density BMD were determined. The primary outcome measure was change in SUVmax g/ml. RESULTS:Mid-foot was the most common region involved. After 12 months, SUVmax increased from 30.6 ± 14.7 to 37.7 ± 18.0 (P = 0.044) in the teriparatide group, but decreased from 27.6 ± 12.2 to 22.9 ± 10.4 with placebo (P = 0.148). The estimated treatment difference (ETD) was 11.9 ± 4.3 (95% CI 2.9, 20.8; P = 0.012). Similarly, P1NP increased with teriparatide (19.8 ± 5.5; P = 0.006) but decreased with placebo (-5.1 ± 3.8 ng/mL; P = 0.219); ETD was 24.8 ± 6.6 (95% CI 10.8, 38.8; P < 0.001) and CTX increased in both the teriparatide and placebo groups. Foot BMD increased by 0.06 ± 0.04 g/cm2 (P = 0.192) with teriparatide, but decreased by -0.06 ± 0.08 g/cm2 with placebo (P = 0.488; intergroup comparison, P = 0.096). CONCLUSION:Teriparatide increases foot bone remodeling by an osteoanabolic action in people with CN. :摘要: 背景目前除了有效的减负治疗外，对慢性足部夏科神经关节病(Charcot neuroarthropathy，CN)还没有公认有效的药物治疗方法。因为跗骨主要是小梁骨，特立帕肽可以改善慢性CN患者的足骨宏观结构。方法合并慢性CN的糖尿病患者被随机分配到每日皮下注射20μg特立帕肽治疗组或者安慰剂组，共治疗12个月。总共筛查了38名患者，对其中20名患者的数据进行了分析。测定了需要关注的区域使用18 F-FDG PET/CT扫描后的最大标准化摄取值(maximum standardized uptake，SUVmax )、骨转换标志物以及足骨密度(bone mineral density，BMD)。主要结果是测量SUVmax g/mL的变化。结果中足是最常累及的部位。经过12月的治疗后，特立帕肽组的SUVmax 从30.6 ± 14.7增加到37.7 ± 18.0(P = 0.044)，但是安慰剂组却从27.6 ± 12.2下降至22.9 ± 10.4(P = 0.148)。估计治疗差异(estimated treatment difference，ETD)为11.9 ± 4.3(95% CI为2.9，20.8；P = 0.012)。同样，特立帕肽组的I型前胶原氨基端原肽(procollagen type 1 N-terminal propeptide, P1NP)增加了(19.8 ± 5.5；P = 0.006)，但是安慰剂组却下降了(−5.1 ± 3.8 ng/mL；P = 0.219)；ETD为24.8 ± 6.6(95% CI为10.8，38.8；P < 0.001)，但是在特立帕肽组与安慰剂组中I 型胶原羧基末端肽(C-terminal telopeptide of type 1 collagen, CTX)都增加了。特立帕肽组的足部BMD增加了0.06 ± 0.04 g/cm2 (P = 0.192)，但是安慰剂组却减少了−0.06 ± 0.08 g/cm2 (P = 0.488；组间比较，P = 0.096)。结论在CN患者中特立帕肽通过促进骨合成作用可改善足骨重塑。.

journal_name

J Diabetes

journal_title

Journal of diabetes

authors

Rastogi A,Hajela A,Prakash M,Khandelwal N,Kumar R,Bhattacharya A,Mittal BR,Bhansali A,Armstrong DG

doi

10.1111/1753-0407.12902

subject

Has Abstract

pub_date

2019-09-01 00:00:00

pages

703-710

issue

eissn

1753-0393

issn

1753-0407

journal_volume

pub_type

杂志文章,随机对照试验

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Teriparatide (recombinant human parathyroid hormone [1-34]) increases foot bone remodeling in diabetic chronic Charcot neuroarthropathy: a randomized double-blind placebo-controlled study.