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The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

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Rigshospitalet

Status

Completed

Conditions

Metabolic Bone Disease
Hyponatremia

Treatments

Drug: Placebo Oral Tablet
Drug: Sodium chloride

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

21 participants in 2 patient groups, including a placebo group

Sodium arm
Active Comparator group
Description:
Sodium tablets
Treatment:
Drug: Sodium chloride
Placebo arm
Placebo Comparator group
Description:
Placebo tablets
Treatment:
Drug: Placebo Oral Tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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