Bone density assessment in patients with partial-onset epileptic seizures

• Conditions: G40.1; G40.2; G40.6; Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures; Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures; Grand mal seizures, unspecified (with or without petit mal)

• Registration Number: DRKS00010430
• Lead Sponsor: niversitätsklinikum FreiburgEpilepsiezentrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-06
• Study Completion: 2020-07-31
• Results First Posted: 2023-11-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1.Male and female patients = 18 years of age;
2.Patients with partial-onset seizures with or without secondary generalization;
3.Treatment with eslicarbazepine-acetate;
4.Written informed consent to participate in the trial and ability to adhere to the protocol

Exclusion Criteria

1.Comedication with phenobarbitone, primidone, carbamazepine, phenytoin, oxcarbazepine, valproate, corticosteroids;
2.Known pregnancy or planned pregnancy;
3.Immobilized patients;
4.Preexisting bone disease

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone density at baseline and at visit month 12 (measured by DXA hip and spine) will be compared intra-individually in the complete patient group.

Secondary Outcome Measures

Name	Time	Method
aboratory tests related to bone metabolism; additional parameters of treatment efficacy and tolerability are assessed systematically using seizure diaries and standardized questionnaires.<br>