Shaanxi University of Chinese Medicine, Xi'an, 712046, China.
Affiliated Hospital of Shaanxi University of Chinese Medicine, Xi'an, 712083, China.
Trials. 2024 Sep 30;25(1):638. doi: 10.1186/s13063-024-08498-8.
Osteo-sarcopenia (OS) has become a global public health problem and a frontier research problem, as a combination of sarcopenia (SP) and osteoporosis (OP) diseases. The clinical performances include muscle weakness, systemic bone pain, standing difficulty, even falls and fractures, etc., which seriously affect the patient's life and work. The pathological mechanism of the OS may be the abnormal metabolism which disrupts the equilibrium stability of the musculoskeletal system. Therefore, this study combined vitamin D (Vit. D) and whole-body vibration training (WBVT) to intervene in subjects of OS, aiming to evaluate the effectiveness and safety of the diagnosis and treatment protocol and to explore the efficacy mechanism.
We propose a multicenter, parallel-group clinical trial to evaluate the efficacy and safety of Vit. D combined with WBVT intervention in OS. Subjects who met the inclusion or exclusion criteria and signed the informed consent form would be randomly assigned to the WBVT group, Vit. D group, or WBVT+ Vit. D group. All subjects will be treated for 1 month and followed up after 3 and 6 months. The primary outcomes are lumbar bone mineral density (BMD) and appendicular skeletal muscle mass (ASM) measured by dual-energy X-ray absorptiometry (DXA) and handgrip strength measured by grip strength meter. Secondary outcomes include serum markers of myostatin (MSTN), irisin and bone turnover markers (BTM), SARC-CalF questionnaire, 1-min test question of osteoporosis risk, patient health status (evaluated by the SF-36 health survey), physical performance measurement that includes 5-time chair stand test, 6-m walk, and the short physical performance battery (SPPB).
If Vit. D combined with WBVT can well relieve OS symptoms without adverse effects, this protocol may be a new treatment strategy for OS. After therapeutic intervention, if the serum marker MSTN/irisin is significant, both have the potential to become sensitive indicators for screening OS effective drugs and treatments, which also indicates that WBVT combined with Vit. D plays a role in improving OS by regulating MSTN/irisin.
Chinese Clinical Trial Registry ChiCTR2400082269 . Registered on March 26, 2024.
骨肌减少症（OS）是一种将肌肉减少症（SP）和骨质疏松症（OP）合并而成的全球性公共健康问题和前沿研究问题。其临床表现包括肌肉无力、全身骨痛、站立困难，甚至跌倒和骨折等，严重影响患者的生活和工作。OS 的病理机制可能是异常代谢破坏了骨骼肌肉系统的平衡稳定性。因此，本研究结合维生素 D（Vit. D）和全身振动训练（WBVT）对 OS 受试者进行干预，旨在评估诊断和治疗方案的有效性和安全性，并探讨疗效机制。
我们提出了一项多中心、平行组临床试验，以评估 Vit. D 联合 WBVT 干预 OS 的疗效和安全性。符合纳入或排除标准并签署知情同意书的受试者将被随机分配到 WBVT 组、Vit. D 组或 WBVT+Vit. D 组。所有受试者将接受为期 1 个月的治疗，并在 3 个月和 6 个月后进行随访。主要结局指标为双能 X 射线吸收仪（DXA）测量的腰椎骨密度（BMD）和四肢骨骼肌质量（ASM）以及握力计测量的握力。次要结局指标包括肌肉生长抑制素（MSTN）、鸢尾素和骨转换标志物（BTM）的血清标志物、SARC-CalF 问卷、骨质疏松风险 1 分钟测试问题、患者健康状况（由 SF-36 健康调查评估）、包括 5 次坐立测试、6 米步行和简短身体表现电池（SPPB）在内的身体性能测量。
如果 Vit. D 联合 WBVT 能很好地缓解 OS 症状而无不良反应，该方案可能成为 OS 的新治疗策略。经过治疗干预，如果血清标志物 MSTN/irisin 显著，两者都有可能成为筛选 OS 有效药物和治疗方法的敏感指标，这也表明 WBVT 联合 Vit. D 通过调节 MSTN/irisin 发挥改善 OS 的作用。
中国临床试验注册中心 ChiCTR2400082269。注册于 2024 年 3 月 26 日。
