Evidence map›Paper›PMID 39638959›Full record

Observational studyCNS drugs2025

Effects of One-Year Anti-seizure Treatment with Add-On Cenobamate on Bone Density and Bone Turnover in Adults with Drug-Resistant Focal Epilepsy: An Observational Study.

Yulia Novitskaya, Andreas Schulze-Bonhage, Elisa Schütz, Martin Hirsch

Abstract readObservational Study
In one paragraph

Observational study in CNS drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. The Neurology of Menopause.Current neurology and neuroscience reports · 2026
    Review
  2. Review
  3. Review
  4. Article
  5. Antiseizure Medications and Bone Health.Neurology and therapy · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Yulia NovitskayaEpilepsy Center, Department of Neurosurgery, Faculty of Medicine, University of Freiburg, Breisacher Strasse 64, 79106, Freiburg, Germany. yulia.novitskaya@uniklinik-freiburg.de.ORCID 0000-0002-0905-9936
Andreas Schulze-BonhageEpilepsy Center, Department of Neurosurgery, Faculty of Medicine, University of Freiburg, Breisacher Strasse 64, 79106, Freiburg, Germany.
Elisa SchützEpilepsy Center, Department of Neurosurgery, Faculty of Medicine, University of Freiburg, Breisacher Strasse 64, 79106, Freiburg, Germany.
Martin HirschEpilepsy Center, Department of Neurosurgery, Faculty of Medicine, University of Freiburg, Breisacher Strasse 64, 79106, Freiburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveCenobamate is a novel anti-seizure medication (ASM) with unusually high responder rates even in patients with refractory epilepsy. Due to its enzyme-inducing properties, cenobamate could negatively affect bone metabolism, similar to other ASMs; however, effects of long-term cenobamate treatment on bone health have not yet been investigated. The aim of this longitudinal observational study was to assess the effects of 1 year of continuous, adjunctive cenobamate treatment on bone health in patients with drug-resistant, focal epilepsy.

methodsAdult patients from a tertiary epilepsy centre received cenobamate add-on to their concomitant anti-seizure medication. Bone mineral density at femoral neck and lumbar spine, as well as bone formation biomarkers, electrolytes and liver enzymes in serum were assessed at baseline and after 12 months of continuous cenobamate therapy.

resultsForty-seven patients (29 male, median age 40 years) were included in the study. Median daily dose of cenobamate at 12 months was 250 mg. Moderate, yet statistically significant reduction of the T-score at femoral neck but not lumbar spine was found after 1 year of cenobamate treatment, also in a subgroup of patients (n = 37) without enzyme inducers in the comedication. Additionally, we observed statistically significant changes in bone formation biomarkers: decreased serum level of osteocalcin and increased bone-specific alkaline phosphatase. Bone minerals (calcium and phosphorus) as well as vitamin D3 remained unchanged. Parathormone was statistically significantly reduced. There was a highly statistically significant increase in serum gamma-glutamyl transferase (GGT) levels after 12 months of treatment, reflecting an underlying hepatic enzyme induction by cenobamate.

conclusionA statistically significant decrease of the T-score at femoral neck, as well as prominent alterations in the bone formation biomarkers, suggest an increase in bone turnover after 1 year of cenobamate treatment. The underlying mechanism is most likely attributed to the hepatic enzyme activation, indicated by a prominent elevation of serum GGT. The results alert for bone density control in susceptible patient groups. TRIAL REGISTRATION NUMBER: DRKS00027568, March 2, 2022 retrospectively registered.

Indexed as

AnticonvulsantsBone DensityBone RemodelingCarbamatesDrug Resistant EpilepsyAdultChlorophenolsDrug Therapy, CombinationEpilepsies, PartialFemaleHumansLongitudinal StudiesMaleMiddle AgedTetrazolesYoung AdultAnticonvulsantsCarbamatesCenobamateChlorophenolsTetrazoles

Identifiers

PMID39638959
PMCPMC11695382

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.