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

Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients - A Prospective Study (BONA-Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Hyponatremia
• Intervention / Treatment: Other: blood sampling

• Study Type: Observational
• Enrollment (Estimated): 52

Contacts and Locations

• Study Contact: Name: Mirjam Christ-Crain, Prof. Dr. med; Phone Number: +41 61 265 25 25; Email: mirjam.christ@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Endocrinology, Diabetes and Metabolism, University Hospital Basel
    • Contact: Mirjam Christ-Crain, Prof. Dr. med; Phone Number: +41 61 265 25 25; Email: mirjam.christ@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hyponatremic patients; Patients hospitalized at the University Hospital of Basel and presenting with hyponatremia will be screened for the study	Other: blood sampling; blood sampling for measurement of bone markers after a fasting period of at least 6 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in bone specific alkaline phosphatase (bAP)	bAP levels and their 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 osteocalcin	Osteocalcin (ng/mL) levels and their 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 procollagen type I N propeptide (PINP) (PINP) levels	PINP (ng/mL) levels and their 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 sclerostin	Sclerostin (pg/ml) levels and their 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 parathyroid hormone (PTH)	PTH (pg/ml) levels and their dynamic within 10 days of hospitalization	changes from baseline (day 1) to day 10 after inclusion in the study
Change in 25-hydroxy-vitamin D3	25-hydroxy-vitamin D3 (ng/ml) levels and their 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 calcium	Calcium (mg/dl) levels and their 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 phosphate levels	Phosphate(mg/dl) levels and their 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
Numbers of falls	telephone interview will be performed to collect data about occurrence and numbers of falls within 30 days after enrolment	numbers of falls within 30 days after enrolment
Numbers of fractures	telephone interview will be performed to collect data about occurrence and numbers of fractures within 30 days after enrolment	Numbers of fractures within 30 days after inclusion in the study

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Mirjam Christ-Crain, Prof. Dr. med, Endocrinology, Diabetology and Metabolism, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Bone Metabolism; electrolyte disorder; Sodium Levels
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: 2019-01858; me18ChristCrain6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No