Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients

Recruiting

• Conditions: Hyponatremia
• Interventions: Other: blood sampling

• Registration Number: NCT04227301
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyponatremic patients	blood sampling	Patients hospitalized at the University Hospital of Basel and presenting with hyponatremia will be screened for the study

Primary Outcome Measures

Name	Time	Method
Change in plasma sodium level	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	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

Secondary Outcome Measures

Name	Time	Method
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	25-hydroxy-vitamin D3 (ng/ml) levels and their dynamic within 10 days of hospitalization
Numbers of falls	numbers of falls within 30 days after enrolment	telephone interview will be performed to collect data about occurrence and 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	Osteocalcin (ng/mL) levels and their dynamic within 10 days of hospitalization
Numbers of fractures	Numbers of fractures within 30 days after inclusion in the study	telephone interview will be performed to collect data about occurrence and numbers of fractures within 30 days after enrolment
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	PINP (ng/mL) levels and their dynamic within 10 days of hospitalization
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	Phosphate(mg/dl) levels and their dynamic within 10 days of hospitalization
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	bAP levels and their dynamic within 10 days of hospitalization
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	Sclerostin (pg/ml) levels and their dynamic within 10 days of hospitalization
Change in parathyroid hormone (PTH)	changes from baseline (day 1) to day 10 after inclusion in the study	PTH (pg/ml) levels and their dynamic within 10 days of hospitalization
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	Calcium (mg/dl) levels and their dynamic within 10 days of hospitalization

Trial Locations

Locations (1)

Endocrinology, Diabetes and Metabolism, University Hospital Basel; 🇨🇭 Basel, Switzerland