Testosterone therapy and bone quality in men with diabetes and hypogonadism: Study design and protocol.
Testosterone therapy and bone quality in men with diabetes and hypogonadism: Study design and protocol.
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DOI：
10.1016/j.conctc.2021.100723
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发表时间：
2021-03
影响因子：
1.5
通讯作者：
Armamento-Villareal R
中科院分区：
文献类型：
--
作者：
Russo V;Colleluori G;Chen R;Mediwala S;Qualls C;Liebschner M;Villareal DT;Armamento-Villareal R
2型糖尿病（T2D）通常伴有男性性腺功能减退，这两种情况都与骨折风险增加有关。睾酮(T)已被证明可以改善性腺功能低下男性的骨骼健康，但尚未在同时患有T2D和低T的患者中进行测试。迄今为止，没有专门推荐用于T2D患者骨病的治疗。本研究将评估睾酮治疗对患有t22d的低睾酮男性退伍军人骨骼健康的影响。这是一项随机双盲安慰剂对照试验，166名35-65岁的男性退伍军人，患有T2D和性腺功能减退症，随机分为1.62%的T凝胶或安慰剂，为期12个月。我们将评估T疗法对以下主要结果的影响：1)高分辨率外围定量计算机断层扫描微有限元分析（μFEA）测量骨强度的变化，2)骨转换标志物的变化，以及3)循环成骨细胞祖细胞（COP）和破骨细胞前体细胞的变化。我们预计T疗法将导致骨强度的改善，因为在性腺功能减退和T2D患者中，通过增加成骨细胞分化和增殖来改善骨重塑。
Type 2 diabetes mellitus (T2D) is often accompanied by male hypogonadism and both conditions are associated with increased risk for fractures. Testosterone (T) has been shown to improve the bone health of hypogonadal men but has not been tested in patients who also have T2D in addition to low T. To date, there is no treatment that is specifically recommended for bone disease among patients with T2D. This study will evaluate the effect of T therapy on the bone health of male veterans with low T who also have T2D. This is a randomized double-blind placebo-controlled trial of 166 male veterans 35–65 years old, with T2D and hypogonadism, randomized to either T gel 1.62% or placebo for 12 months. We will evaluate the effect of T therapy on the following primary outcomes:1) changes in bone strength as measured by microfinite elements analysis (μFEA) using high-resolution peripheral quantitative computer tomography, 2) changes in bone turnover markers, and 3) changes in circulating osteoblast progenitors (COP) and osteoclast precursors cells. We anticipate that T therapy will result in improvement in bone strength owing to improvement in bone remodeling through an increase in osteoblastic differentiation and proliferation in patients with hypogonadism and T2D.
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DOI：
10.1002/jbmr.3109
发表时间：
2017-06
期刊：
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research
影响因子：
--
作者：
Cohen A;Kousteni S;Bisikirska B;Shah JG;Manavalan JS;Recker RR;Lappe J;Dempster DW;Zhou H;McMahon DJ;Bucovsky M;Kamanda-Kosseh M;Stubby J;Shane E
通讯作者：
Shane E
影响因子：
4.3
作者：
Cheung AM;Adachi JD;Hanley DA;Kendler DL;Davison KS;Josse R;Brown JP;Ste-Marie LG;Kremer R;Erlandson MC;Dian L;Burghardt AJ;Boyd SK
通讯作者：
Boyd SK
影响因子：
158.5
作者：
Eghbali-Fatourechi, GZ;Lamsam, J;Khosla, S
通讯作者：
Khosla, S
影响因子：
5.8
作者：
Burghardt, Andrew J.;Issever, Ahi S.;Link, Thomas M.
通讯作者：
Link, Thomas M.
影响因子：
16.2
作者：
Dhindsa, Sandeep;Bhatia, Vishal;Dandona, Paresh
通讯作者：
Dandona, Paresh