The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

Study Overview
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Brief Summary
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The study investigates the association between normalization of serum sodium levels and bone markers in patients with epilepsy and chronic hyponatremia. The study is a randomized, single blinded, placebo controlled study where participants will be randomized to either treatment with salt tablets or placebo tablets through 4 months. At the beginning and end of the 4 months bone markers will be measured. The investigators null-hypothesis is that there will be no difference in bone markers before or after the intervention.

Official Title
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The Effect of Normalization of Sodium on Bone Markers in Patients With Epilepsy. A Randomized Single-blinded Placebo-controlled Trial.

Conditions
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Hyponatremia, Metabolic Bone Disease

Intervention / Treatment
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* Drug: Sodium chloride
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epilepsy requiring treatment for at least 2 years Known hyponatremia (2 subsequent s-sodium values < 136 mmol/l) Age 18-80 years Danish speaking Signed form of prior consent Exclusion Criteria: Pregnancy and breastfeeding Known osteoporosis. DXA scan < -2.5 T-score. Z-score is used for patients 50 years or younger. Undergoing treatment for osteoporosis Undergoing treatment with salt tablets Known SIADH Severe concomitant disease such as cancer or ischemic heart disease Alcohol, drug or substance abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium arm<br>Sodium tablets | Drug: Sodium chloride<br>* Sodium chloride tablets, 250 mg<br>|
| Placebo Comparator: Placebo arm<br>Placebo tablets | Drug: Placebo Oral Tablet<br>* Starch tablets<br>* Other names: Strarch tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTX1 change | bone markers | At baseline and after 4 months intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P1NP change | Bone markers | At baseline and after 4 months intervention | 
| DXA scan change | Density measurements | At baseline and after 4 months intervention | 
| Cognitive function change | Epitrack test, scale from 9-49 (9 worst score - 49 best score) | At baseline and after 4 months intervention | 
| Life quality change | Quoli 31, scale from 0-100 (0 lowest life quality - 100 best life quality) | At baseline and after 4 months intervention | 
| Change in daily pains | VAS from 0-10 (0 no pains - 10 maximum pain) | At baseline and after 4 months intervention |