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临床试验/NCT06095349
NCT06095349已完成不适用

Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Measurement of biomarkers of bone turnover, marker #1

研究概览

简要总结

The aim of the study is to investigate whether inhalation treatment with high-sulfide waters from some spas (referred to as "thermal waters"), performed for 12 consecutive days, is able to change circulating H2S levels and alter bone metabolism. Identifying a clear correlation between circulating levels of H2S and sulfur water administration, as well as a potential anabolic effect on bone, would set the stage for new studies that could have important clinical implications for promoting health and preventing osteoporosis

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • post-menopausal women with a diagnosis of osteopenia

排除标准

  • concurrent muscoloskeletal conditions or chronic pharmacological treatment interfering with bone metabolism

结局指标

主要结局

Measurement of biomarkers of bone turnover, marker #1

时间窗: 15 days

Procollagen type 1 N-terminal propeptide (P1NP), marker of bone formation

Measurement of biomarkers of bone turnover, marker #2

时间窗: 15 days

Bone-specific alkaline phosphatase (BAP), marker of bone formation

Measurement of biomarkers of bone turnover, marker #3

时间窗: 15 days

serum C-terminal telopeptide of type I collagen (CTX-1), marker of bone resorption

次要结局

  • Measurement of serum H2S levels(15 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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