癸酸诺龙在绝经后女性骨质疏松症管理中的作用研究:一项前瞻性观察性研究。

Investigating the Role of Nandrolone Decanoate in the Management of Osteosarcopenia in Postmenopausal Women: A Prospective Observational Study.

作者信息

Dave Bharat, Agarawal Sandesh, Krishnan Ajay, Mayi Shivanand, Rai Ravi R, Dave Mirant B, Anil Abhijith

机构信息

Spine Surgery, Stavya Spine Hospital and Research Institute, Ahmedabad, IND.

出版信息

Cureus. 2025 May 24;17(5):e84726. doi: 10.7759/cureus.84726. eCollection 2025 May.

Abstract

Introduction Sarcopenia and osteoporosis are progressive, age-related conditions that often coexist in older adults, resulting in a combined syndrome known as osteosarcopenia. This condition is characterized by a decline in bone mineral density (BMD) and skeletal muscle mass, contributing to increased functional impairment and diminished quality of life. While pharmacological agents such as alendronate are used in the management of osteoporosis, there are currently no Food and Drug Administration (FDA)-approved treatments that specifically address sarcopenia. This study explores the therapeutic potential and safety of incorporating nandrolone decanoate, an anabolic steroid, into an alendronate regimen for the management of osteosarcopenia. Methodology This prospective, single-center study was conducted at a tertiary care spine hospital in India. The study enrolled 100 postmenopausal women between the ages of 45 and 80, all diagnosed with osteoporosis using dual-energy X-ray absorptiometry (DEXA). Each participant received intramuscular nandrolone decanoate at a dose of 50 mg every three weeks for 12 weeks, followed by four-weekly injections. This regimen was administered alongside weekly oral alendronate for one year. All participants also received routine calcium and vitamin D supplementation. Assessments were performed at baseline and after 12 months, including DEXA scans to evaluate BMD, lean body mass, and fat mass. Patient-reported outcomes were captured using the Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and a standardized Quality of Life Score (QoLS). Adverse events were recorded at 3, 6, and 12 months to evaluate treatment safety. Results A total of 89 out of the 100 enrolled participants completed the study. Baseline assessments revealed median BMD T-scores of -3.1 at the lumbar spine and -2.9 at Ward's triangle. The mean lean body mass was 31,984.07 g, while the mean total body fat mass was 25,966.96 g. After 12 months, BMD significantly improved at both the lumbar spine and hip. Lean body mass increased from 31,984 to 33,062 g, while total fat mass decreased slightly, although the change was not statistically significant. Patient-reported outcomes revealed substantial improvement in back pain (VAS), disability (ODI), and QoLS. No adverse events were recorded throughout the study period. Conclusion The incorporation of nandrolone decanoate with alendronate therapy significantly improved lean body mass, BMD, and patient-reported outcomes among postmenopausal women with osteosarcopenia. This therapeutic combination exhibited an excellent safety profile, with no adverse events recorded throughout the study period. These findings highlight the potential of nandrolone decanoate as an effective adjunct in the integrated management of osteoporosis and sarcopenia, contributing to improved overall patient health outcomes. However, further longitudinal studies are required to assess the long-term safety and efficacy of this therapeutic approach.

摘要

引言

肌肉减少症和骨质疏松症是与年龄相关的渐进性疾病,在老年人中常常并存,导致一种称为骨肌减少症的综合征。这种病症的特征是骨矿物质密度(BMD)和骨骼肌质量下降,导致功能障碍增加和生活质量降低。虽然诸如阿仑膦酸盐等药物用于治疗骨质疏松症,但目前尚无美国食品药品监督管理局(FDA)批准的专门针对肌肉减少症的治疗方法。本研究探讨了将癸酸诺龙(一种合成代谢类固醇)纳入阿仑膦酸盐治疗方案用于管理骨肌减少症的治疗潜力和安全性。

方法

这项前瞻性、单中心研究在印度一家三级护理脊柱医院进行。该研究招募了100名年龄在45至80岁之间的绝经后妇女,她们均使用双能X线吸收法(DEXA)诊断为骨质疏松症。每位参与者每三周接受一次50毫克的肌肉注射癸酸诺龙,共12周,之后改为四周注射一次。该方案与每周口服阿仑膦酸盐一起使用一年。所有参与者还接受常规的钙和维生素D补充。在基线和12个月后进行评估,包括DEXA扫描以评估BMD、瘦体重和脂肪量。使用Oswestry功能障碍指数(ODI)、视觉模拟量表(VAS)和标准化生活质量评分(QoLS)来获取患者报告的结果。在3个月、6个月和12个月记录不良事件以评估治疗安全性。

结果

100名登记参与者中有89名完成了研究。基线评估显示腰椎的BMD T值中位数为-3.1,沃德三角区为-2.9。平均瘦体重为31,984.07克,而平均全身脂肪量为25,966.96克。12个月后,腰椎和髋部的BMD均显著改善。瘦体重从31,984克增加到33,062克,而总脂肪量略有下降,尽管变化无统计学意义。患者报告的结果显示背痛(VAS)、功能障碍(ODI)和QoLS有显著改善。在整个研究期间未记录到不良事件。

结论

将癸酸诺龙与阿仑膦酸盐治疗相结合可显著改善骨肌减少症绝经后妇女的瘦体重、BMD和患者报告的结果。这种治疗组合显示出极佳的安全性,在整个研究期间未记录到不良事件。这些发现突出了癸酸诺龙作为骨质疏松症和肌肉减少症综合管理中有效辅助药物的潜力,有助于改善患者的整体健康结果。然而,需要进一步的纵向研究来评估这种治疗方法的长期安全性和有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a4a3/12183668/c284d4e0a9ed/cureus-0017-00000084726-i01.jpg

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