BONA: Influence of Serum Sodium Levels on Bone Metabolism and Turnover in Hospitalized Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in carboxy-terminal collagen crosslinks (CTX) levels [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 [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 Outcome Measures
- 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 earlier]
bAP levels and their dynamic within 10 days of hospitalization
- Change in osteocalcin [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
- Change in procollagen type I N propeptide (PINP) (PINP) levels [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
- Change in sclerostin [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
- Change in parathyroid hormone (PTH) [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
- Change in 25-hydroxy-vitamin D3 [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
- Change in calcium [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
- Change in phosphate levels [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
- Numbers of falls [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 fractures [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
Eligibility Criteria
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)
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End stage kidney disease (dialysis)
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Acute liver failure
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Wernicke encephalopathy
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Hepatic encephalopathy during last 2 months
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Hepato-renal syndrome
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Any bone disease requiring treatment in the last three years
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History of fragility fractures
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Pre-menopausal women
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Hypogonadism (diagnosed before hospitalization)
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Hyperthyroidism
-
Steroid therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endocrinology, Diabetes and Metabolism, University Hospital Basel | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Mirjam Christ-Crain, Prof. Dr. med, Endocrinology, Diabetology and Metabolism, University Hospital Basel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-01858; me18ChristCrain6