Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371199
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Sarah Seberg Diemar, 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.


Condition or disease Intervention/treatment Phase
Hyponatremia Metabolic Bone Disease Drug: Sodium chloride Drug: Placebo Oral Tablet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : December 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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 Name: Strarch tablets




Primary Outcome Measures :
  1. CTX1 change [ Time Frame: At baseline and after 4 months intervention ]
    bone markers


Secondary Outcome Measures :
  1. P1NP change [ Time Frame: At baseline and after 4 months intervention ]
    Bone markers

  2. DXA scan change [ Time Frame: At baseline and after 4 months intervention ]
    Density measurements

  3. Cognitive function change [ Time Frame: At baseline and after 4 months intervention ]
    Epitrack test, scale from 9-49 (9 worst score - 49 best score)

  4. 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)

  5. Change in daily pains [ Time Frame: At baseline and after 4 months intervention ]
    VAS from 0-10 (0 no pains - 10 maximum pain)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371199


Locations
Layout table for location information
Denmark
Rigshospitalet Glostrup
Glostrup, Denmark, 2600
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Layout table for investigator information
Study Chair: Noémi B Andersen, DMSc, MD Senoir consultant

Publications:

Layout table for additonal information
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: December 13, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have currently no plan to share individual patient data, but if relevant if relevant it could occur.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Bone Diseases
Bone Diseases, Metabolic
Epilepsy
Hyponatremia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Musculoskeletal Diseases