Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients (NCT04227301) | Clinical Trial Compass
CompletedNot Applicable
Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients
Switzerland52 participantsStarted 2020-02-13
Plain-language summary
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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in carboxy-terminal collagen crosslinks (CTX) levels
Timeframe: 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
2
Change in plasma sodium level
Timeframe: 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