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The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03371199
Collaborator
(none)
21
Enrollment
1
Location
2
Arms
13
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium chloride
  • Drug: Placebo Oral Tablet
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Effect of Normalization of Sodium on Bone Markers in Patients With Epilepsy. A Randomized Single-blinded Placebo-controlled Trial.
Actual Study Start Date :
Dec 1, 2017
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CTX1 change [At baseline and after 4 months intervention]

      bone markers

    Secondary Outcome Measures

    1. P1NP change [At baseline and after 4 months intervention]

      Bone markers

    2. DXA scan change [At baseline and after 4 months intervention]

      Density measurements

    3. Cognitive function change [At baseline and after 4 months intervention]

      Epitrack test, scale from 9-49 (9 worst score - 49 best score)

    4. Life quality change [At baseline and after 4 months intervention]

      Quoli 31, scale from 0-100 (0 lowest life quality - 100 best life quality)

    5. Change in daily pains [At baseline and after 4 months intervention]

      VAS from 0-10 (0 no pains - 10 maximum pain)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Glostrup Glostrup Denmark 2600

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sarah Seberg Diemar, Medical Doctor, ph.d. student, principal investigator, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT03371199
    Other Study ID Numbers:
    • 57353
    First Posted:
    Dec 13, 2017
    Last Update Posted:
    Mar 28, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bone Diseases
    Bone Diseases, Metabolic
    Epilepsy
    Hyponatremia

    Study Results

    No Results Posted as of Mar 28, 2019