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OpenTrials
Completed

NCT Number: NCT03371199

The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

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.

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Key information

Conditions

Hyponatremia Bone Diseases Bone Diseases, Metabolic Metabolic Bone Disease Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Chloride

Drug

Sodium chloride tablets, 250 mg

Placebo oral tablet

Drug

Starch tablets

Other names: Strarch tablets

Primary outcomes

  1. CTX1 change

    Time frame: At baseline and after 4 months intervention

    bone markers

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2017
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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