The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03371199

Enrollment

Registered

2017-12-13

Start date

2017-12-01

Completion date

2018-12-31

Last updated

2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia, Metabolic Bone Disease

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.

Interventions

DRUGSodium chloride

Sodium chloride tablets, 250 mg

DRUGPlacebo Oral Tablet

Starch tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
CTX1 change	At baseline and after 4 months intervention	bone markers

Secondary

Measure	Time frame	Description
P1NP change	At baseline and after 4 months intervention	Bone markers
DXA scan change	At baseline and after 4 months intervention	Density measurements
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)
Change in daily pains	At baseline and after 4 months intervention	VAS from 0-10 (0 no pains - 10 maximum pain)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026