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

Hyponatremia Clinical Trial

— BONA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04227301
• Other study ID #: 2019-01858; me18ChristCrain6
• Status: Recruiting
• Start date: November 14, 2019
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Mirjam Christ-Crain, Prof. Dr. med
• Phone: +41 61 265 25 25
• Email: mirjam.christ[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyponatremia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Endocrinology, Diabetes and Metabolism, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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