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

May 28, 2025 updated by: University Hospital, Basel, Switzerland

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • Endocrinology, Diabetes and Metabolism, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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)
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
changes from baseline (day 1) to day 10 after inclusion in the study
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
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
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
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
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
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
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
numbers of falls within 30 days after enrolment
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
Numbers of fractures within 30 days after inclusion in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mirjam Christ-Crain, Prof. Dr. med, Endocrinology, Diabetology and Metabolism, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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