The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

Not Applicable

Completed

• Conditions: Hyponatremia; Metabolic Bone Disease
• Interventions: Drug: Sodium chloride; Drug: Placebo Oral Tablet

• Registration Number: NCT03371199
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-30
• Study Start: 2017-12-01
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-13
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium arm	Sodium chloride	Sodium tablets
Placebo arm	Placebo Oral Tablet	Placebo tablets

Primary Outcome Measures

Name	Time	Method
CTX1 change	At baseline and after 4 months intervention	bone markers

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet Glostrup; 🇩🇰 Glostrup, Denmark