Stapleton Joshua R, Ard Jamy D, Beavers Daniel P, Cogdill Lori S, Fernandez Adolfo Z, Howard Marjorie J, Justice Jamie N, Lynch S Delanie, Newman Jovita J, Weaver Ashley A, Beavers Kristen M
Department of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Weight Management Center, Atrium Health Wake Forest Baptist, Winston-Salem, NC, USA.
Contemp Clin Trials Commun. 2023 Jul 4;34:101181. doi: 10.1016/j.conctc.2023.101181. eCollection 2023 Aug.
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.
尽管肥胖相关合并症有了公认的改善，但越来越多的证据表明，手术减肥会引发骨骼脆弱。袖状胃切除术（SG）是最常用的减肥手术，术后一年内有3%-7%的轴向骨量流失。双膦酸盐是美国食品药品监督管理局（FDA）批准的用于预防和治疗与年龄相关的骨质流失的药物，可能是减少SG手术后骨量流失的一种策略。
减少袖状胃切除术相关骨量流失的策略（STRONG BONES）试验（NCT04922333）旨在明确测试每月服用双膦酸盐利塞膦酸盐六个月是否能有效对抗SG相关的骨量流失。约120名中年及以上（≥40岁）的SG患者将被随机分为接受六个月的利塞膦酸盐或安慰剂治疗，在基线、术后六个月和十二个月评估骨骼结果。该试验的主要结果是通过双能X线吸收法（DXA）测量的全髋部面积骨密度（aBMD）在12个月时的变化。这将通过在其他骨骼部位进行DXA获得的aBMD评估以及定量计算机断层扫描（QCT）得出的骨质量变化来补充。还将评估肌肉质量和功能的变化，以及骨健康、骨转换和相互作用的生物标志物，从而深入了解干预对骨-肌肉单元相关变化的机制。
STRONG BONES试验的结果有可能通过确定使用双膦酸盐减轻中年及老年SG患者骨量流失和伴随骨折风险的能力来影响当前的临床实践。
