Clinical trial NCT04227301: Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients
Official title: Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients - A Prospective Study (BONA-Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Keywords: electrolyte disorder
Bone Metabolism
Sodium Levels
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult hospitalized patients (18 to 99-year-old), with non-hypertonic hyponatremia

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in carboxy-terminal collagen crosslinks (CTX) levels
timeFrame: 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
measure: Change in plasma sodium level
timeFrame: 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:
measure: Changes in bone specific alkaline phosphatase (bAP)
timeFrame: 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
measure: Change in osteocalcin
timeFrame: 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
measure: Change in procollagen type I N propeptide (PINP) (PINP) levels
timeFrame: 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
measure: Change in sclerostin
timeFrame: 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
measure: Change in parathyroid hormone (PTH)
timeFrame: changes from baseline (day 1) to day 10 after inclusion in the study
measure: Change in 25-hydroxy-vitamin D3
timeFrame: 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
measure: Change in calcium
timeFrame: 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
measure: Change in phosphate levels
timeFrame: 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
measure: Numbers of falls
timeFrame: numbers of falls within 30 days after enrolment
measure: Numbers of fractures
timeFrame: Numbers of fractures within 30 days after inclusion in the study
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Endocrinology, Diabetes and Metabolism, University Hospital Basel
Study officials:
affiliation: Endocrinology, Diabetology and Metabolism, University Hospital Basel
name: Mirjam Christ-Crain, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References: