Strategies to reduce the onset of sleeve gastrectomy associated bone loss (STRONG BONES): Trial design and methods.
Strategies to reduce the onset of sleeve gastrectomy associated bone loss (STRONG BONES): Trial design and methods.
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DOI：
10.1016/j.conctc.2023.101181
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发表时间：
2023-08
影响因子：
1.5
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尽管肥胖相关的合并症得到了公认的改善，但越来越多的证据表明手术减肥与骨骼脆性的发生有关。袖状胃切除术（SG）是最常进行的减肥手术，术后一年中轴骨丢失率为3-7%。双膦酸盐是FDA批准的用于预防和治疗年龄相关性骨丢失的药物，可能是减少SG手术后骨丢失的策略。减少袖状胃切除术相关骨丢失发作的策略（STRONG BONES）试验（NCT 04922333）旨在明确测试每月给予双膦酸盐利塞膦酸盐6个月是否可以有效对抗SG相关骨丢失。大约120名中年和老年（≥40岁）SG患者将随机接受6个月的利塞膦酸钠或安慰剂治疗，并在基线、术后6个月和12个月评估骨骼结局。该试验的主要结果是12个月后通过双能X线吸收法（DXA）测量的总髋关节面积骨密度（aBMD）的变化。这将通过其他骨骼部位的DXA获得的aBMD评估和定量计算机断层扫描（QCT）得出的骨质变化进行补充。还将评估肌肉质量和功能的变化，以及骨健康、转换和串扰的生物标志物，为骨-肌肉单位的干预相关变化提供机制性见解。STRONG BONES试验的结果有可能影响当前的临床实践，因为它确定了使用双膦酸盐缓解中老年SG患者骨丢失和伴随骨折风险的能力。
Despite recognized improvements in obesity-related comorbidities, mounting evidence implicates surgical weight loss in the onset of skeletal fragility. Sleeve gastrectomy (SG) is the most commonly performed bariatric procedure and is associated with 3–7% axial bone loss in the year following surgery. Bisphosphonates are FDA-approved medications for the prevention and treatment of age-related bone loss and may represent a strategy to reduce bone loss following SG surgery. The Strategies to Reduce the Onset of Sleeve Gastrectomy Associated Bone Loss (STRONG BONES) trial (NCT04922333) is designed to definitively test whether monthly administration of the bisphosphonate, risedronate, for six months can effectively counter SG-associated bone loss. Approximately 120 middle-aged and older (≥40 years) SG patients will be randomized to six months of risedronate or placebo treatment, with skeletal outcomes assessed at baseline, six, and 12-months post-surgery. The primary outcome of the trial is 12-month change in total hip areal bone mineral density (aBMD), measured by dual energy x-ray absorptiometry (DXA). This will be complemented by DXA-acquired aBMD assessment at other skeletal sites and quantitative computed tomography (QCT) derived changes in bone quality. Change in muscle mass and function will also be assessed, as well as biomarkers of bone health, turnover, and crosstalk, providing mechanistic insight into intervention-related changes to the bone-muscle unit. Results from the STRONG BONES trial have the potential to influence current clinical practice by determining the ability of bisphosphonate use to mitigate bone loss and concomitant fracture risk in middle-aged and older SG patients.