The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

Rigshospitalet

Status: Completed

Conditions: Metabolic Bone Disease; Hyponatremia

Treatments: Drug: Placebo Oral Tablet; Drug: Sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03371199

57353

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

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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