The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

March 26, 2019 updated by: Sarah Seberg Diemar, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Rigshospitalet Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium arm
Sodium tablets
Drug: Sodium chloride
Sodium chloride tablets, 250 mg
Placebo Comparator: Placebo arm
Placebo tablets
Drug: Placebo Oral Tablet
Starch tablets
Other Names:
  • Strarch tablets

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Noémi B Andersen, DMSc, MD, Senoir consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We have currently no plan to share individual patient data, but if relevant if relevant it could occur.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyponatremia

Clinical Trials on Sodium chloride

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe