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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04227301
Acronym
BONA
Enrollment
52
Registered
2020-01-13
Start date
2020-02-13
Completion date
2025-02-24
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia

Keywords

electrolyte disorder, Bone Metabolism, Sodium Levels

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.

Interventions

OTHERblood sampling

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

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in carboxy-terminal collagen crosslinks (CTX) levelsbaseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlierCTX level (pg/ml) and its dynamic within 10 days of hospitalization
Change in plasma sodium levelbaseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlierserum sodium levels (milliequivalents per liter (mEq/L) and its dynamic within 10 days of hospitalization

Secondary

MeasureTime frameDescription
Change in procollagen type I N propeptide (PINP) (PINP) levelsbaseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlierPINP (ng/mL) levels and their dynamic within 10 days of hospitalization
Change in sclerostinbaseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlierSclerostin (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 studyPTH (pg/ml) levels and their dynamic within 10 days of hospitalization
Change in 25-hydroxy-vitamin D3baseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlier25-hydroxy-vitamin D3 (ng/ml) 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 earlierbAP levels and their dynamic within 10 days of hospitalization
Change in phosphate levelsbaseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlierPhosphate(mg/dl) levels and their dynamic within 10 days of hospitalization
Numbers of fallsnumbers of falls within 30 days after enrolmenttelephone interview will be performed to collect data about occurrence and numbers of falls within 30 days after enrolment
Numbers of fracturesNumbers of fractures within 30 days after inclusion in the studytelephone interview will be performed to collect data about occurrence and numbers of fractures within 30 days after enrolment
Change in calciumbaseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlierCalcium (mg/dl) levels and their dynamic within 10 days of hospitalization
Change in osteocalcinbaseline blood exam on day 1 after inclusion and further blood collections at day 10 (+/-3 days) or at discharge, if discharge will be earlierOsteocalcin (ng/mL) levels and their dynamic within 10 days of hospitalization

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026