HyponatremiaBONANCT04227301
Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients
An observational study of Hyponatremia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hyponatremia
- What is being tested?
- blood sampling
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Feb 2020to 24 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult hospitalized patients (18 to 99-year-old), with non-hypertonic hyponatremia
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Endocrinology, Diabetes and Metabolism, University Hospital Basel
Basel, 4031
About this study
Official title: 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.
- Conditions
- Hyponatremia
- Being tested
- blood sampling
- Keywords
- electrolyte disorder, Bone Metabolism, Sodium Levels
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
blood sampling for measurement of bone markers after a fasting period of at least 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Hyponatremic patients | Patients hospitalized at the University Hospital of Basel and presenting with hyponatremia will be screened for the study Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carboxy-terminal collagen crosslinks (CTX) levels
CTX level (pg/ml) and its dynamic within 10 days of hospitalization
Measured: 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
serum sodium levels (milliequivalents per liter (mEq/L) and its dynamic within 10 days of hospitalization
Measured: 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 (10)
Changes in bone specific alkaline phosphatase (bAP)
bAP levels and their dynamic within 10 days of hospitalization
Measured: 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
Osteocalcin (ng/mL) levels and their dynamic within 10 days of hospitalization
Measured: 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
PINP (ng/mL) levels and their dynamic within 10 days of hospitalization
Measured: 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
Sclerostin (pg/ml) levels and their dynamic within 10 days of hospitalization
Measured: 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)
PTH (pg/ml) levels and their dynamic within 10 days of hospitalization
Measured: changes from baseline (day 1) to day 10 after inclusion in the study
Change in 25-hydroxy-vitamin D3
25-hydroxy-vitamin D3 (ng/ml) levels and their dynamic within 10 days of hospitalization
Measured: 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
Calcium (mg/dl) levels and their dynamic within 10 days of hospitalization
Measured: 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
Phosphate(mg/dl) levels and their dynamic within 10 days of hospitalization
Measured: 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
telephone interview will be performed to collect data about occurrence and numbers of falls within 30 days after enrolment
Measured: numbers of falls within 30 days after enrolment
Numbers of fractures
telephone interview will be performed to collect data about occurrence and numbers of fractures within 30 days after enrolment
Measured: Numbers of fractures within 30 days after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start13 Feb 2020
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirjam Christ-Crain, Prof. Dr. med, Principal investigator, Endocrinology, Diabetology and Metabolism, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227301
- Sponsor's protocol ID
- 2019-01858; me18ChristCrain6
- Other IDs
- 2019
- Acronym
- BONA
- Status last verified
- May 2025
- First submitted
- 7 Jan 2020
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients - A Prospective Study (BONA-Trial)
- ClinicalTrials.gov ID
- NCT04227301
- Acronym / sponsor ID
- BONA / 2019-01858; me18ChristCrain6
- Conditions
- Hyponatremia
- Keywords
- electrolyte disorder, Bone Metabolism, Sodium Levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyponatremic patients | – | Other: blood samplingPatients hospitalized at the University Hospital of Basel and presenting with hyponatremia will be screened for the study |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hospitalized patients (18 to 99-year-old), with non-hypertonic hyponatremia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood sampling for measurement of bone markers after a fasting period of at least 6 hours | Other | Hyponatremic patients |
Primary outcome
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
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
10 secondary outcomes
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
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
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
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
Change in parathyroid hormone (PTH)
Time frame: 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
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
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
Numbers of falls
Time frame: numbers of falls within 30 days after enrolment
Numbers of fractures
Time frame: Numbers of fractures within 30 days after inclusion in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Christ-Crain, Prof. Dr. med principal investigator
Endocrinology, Diabetology and Metabolism, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.