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

NCT04227301 | Completed

• 1 other identifier: 2019-01858; me18ChristCrain6
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyponatremia

Keywords

electrolyte disorder; Bone Metabolism; Sodium Levels

Outcome Measures

Primary Outcomes (2)

• Change in carboxy-terminal collagen crosslinks (CTX) levels

  CTX level (pg/ml) and its dynamic within 10 days of hospitalization

  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 plasma sodium level

  serum sodium levels (milliequivalents per liter (mEq/L) and its dynamic within 10 days of hospitalization

  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

Secondary Outcomes (10)

• 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 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

• 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 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

Study Arms (1)

Hyponatremic patients

Patients hospitalized at the University Hospital of Basel and presenting with hyponatremia will be screened for the study

Other: blood sampling

Interventions

blood sampling OTHER

blood sampling for measurement of bone markers after a fasting period of at least 6 hours

Hyponatremic patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult hospitalized patients (18 to 99-year-old), with non-hypertonic hyponatremia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Endocrinology, Diabetes and Metabolism, University Hospital Basel

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological material, i.e. blood samples, will be handled according to good clinical practice and good laboratory practice. Samples will be collected in secure containers (Sarstedt Monovette®) and will be centrifuged to collect serum. Serum will be stored at - 70°C in a thermo-controlled ultra-deep freezer.

MeSH Terms

Conditions

Hyponatremia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mirjam Christ-Crain, Prof. Dr. med

  Endocrinology, Diabetology and Metabolism, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: February 13, 2020
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

CH (1)