Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients - A Prospective Study (BONA-Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in plasma sodium level
研究概览
简要总结
In this study, the possible role of serum sodium concentration and its changes on bone markers in hospitalized, hyponatremic patients is determined. Therefore, it is investigated whether in hospitalized, hyponatremic patients the level of carboxy-terminal collagen crosslinks (CTX) is modified by changes in plasma sodium concentration, independently from the aetiology of hyponatremia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult hospitalized patients with non-hypertonic hyponatremia: serum sodium < 130 mmol/l, serum osmolality < 300 milliosmol /kg
- •age 18 to 99-year-old
- •Informed consent as documented by signature
排除标准
- •Severe symptomatic hyponatremia in need of intensive care treatment
- •Hypertonic hyponatremia with serum osmolality > 300 mOsm/kg
- •End of life care (palliative treatment)
- •End stage kidney disease (dialysis)
- •Acute liver failure
- •Wernicke encephalopathy
- •Hepatic encephalopathy during last 2 months
- •Hepato-renal syndrome
- •Any bone disease requiring treatment in the last three years
- •History of fragility fractures
- •Pre-menopausal women
- •Hypogonadism (diagnosed before hospitalization)
- •Hyperthyroidism
- •Steroid therapy
结局指标
主要结局
Change in plasma sodium level
时间窗: baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier
serum sodium levels (milliequivalents per liter (mEq/L) and its dynamic within 10 days of hospitalization
Change in carboxy-terminal collagen crosslinks (CTX) levels
时间窗: baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier
CTX level (pg/ml) and its dynamic within 10 days of hospitalization
次要结局
- Change in 25-hydroxy-vitamin D3(baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier)
- Numbers of falls(numbers of falls within 30 days after enrolment)
- Change in osteocalcin(baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier)
- Numbers of fractures(Numbers of fractures within 30 days after inclusion in the study)
- Change in procollagen type I N propeptide (PINP) (PINP) levels(baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier)
- Change in phosphate levels(baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier)
- Changes in bone specific alkaline phosphatase (bAP)(baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier)
- Change in sclerostin(baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier)
- Change in parathyroid hormone (PTH)(changes from baseline (day 1) to day 10 after inclusion in the study)
- Change in calcium(baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier)