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NCT Number: NCT04227301

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

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.

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Key information

Conditions

Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinology, Diabetes and Metabolism, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

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

Primary outcomes

  1. Change in carboxy-terminal collagen crosslinks (CTX) levels

    Time frame: 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

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

  2. Change in plasma sodium level

    Time frame: 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

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

Secondary outcomes

  1. Changes in bone specific alkaline phosphatase (bAP)

    Time frame: 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

    bAP levels and their dynamic within 10 days of hospitalization

  2. Change in osteocalcin

    Time frame: 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

    Osteocalcin (ng/mL) levels and their dynamic within 10 days of hospitalization

  3. Change in procollagen type I N propeptide (PINP) (PINP) levels

    Time frame: 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

    PINP (ng/mL) levels and their dynamic within 10 days of hospitalization

  4. Change in sclerostin

    Time frame: 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

    Sclerostin (pg/ml) levels and their dynamic within 10 days of hospitalization

  5. Change in parathyroid hormone (PTH)

    Time frame: changes from baseline (day 1) to day 10 after inclusion in the study

    PTH (pg/ml) levels and their dynamic within 10 days of hospitalization

  6. Change in 25-hydroxy-vitamin D3

    Time frame: 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

    25-hydroxy-vitamin D3 (ng/ml) levels and their dynamic within 10 days of hospitalization

  7. Change in calcium

    Time frame: 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

    Calcium (mg/dl) levels and their dynamic within 10 days of hospitalization

  8. Change in phosphate levels

    Time frame: 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

    Phosphate(mg/dl) levels and their dynamic within 10 days of hospitalization

  9. Numbers of falls

    Time frame: numbers of falls within 30 days after enrolment

    telephone interview will be performed to collect data about occurrence and numbers of falls within 30 days after enrolment

  10. Numbers of fractures

    Time frame: Numbers of fractures within 30 days after inclusion in the study

    telephone interview will be performed to collect data about occurrence and numbers of fractures within 30 days after enrolment

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: BONA

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2020
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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