i6eal.de
DEEN
Start a project
← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2024-513248-27-00

Multicentre, randomized, controlled, open-label, multi-centre medicoeconomic study evaluating the efficacy of adding zoledronic acid or denosumab to Stereotaxic radiotherapy in the treatment of vertebral metastases (ZOSTER)

Public registry stateAuthorised
CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation
REGISTRY FACTS

What CTIS publishes about this trial

EUCT number
2024-513248-27-00
Trial status
Authorised
Sponsor
not published
Trial region
EEA
Phase
5
Trial category
2
Low-intervention trial
no
Estimated EU start
20 July 2020
Decision date
17 June 2024
Published
23 August 2025
Estimated end
23 June 2027
EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“Determination by deep learning of a predictive model for the occurrence of a bone fracture at 1 year based on imaging examinations.”
Source field
authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[10].secondaryObjective
Matched term
deep learning
MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

  • Patients, men or women over 18 old, with inoperable vertebral bone metastases who must beneficit treatment with stereotactic radiotherapy

Therapeutic areas

  • Diseases [C] - Neoplasms [C04]4
COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

France

Authorised
First decision
17 June 2024
Latest decision
22 August 2025
  1. Authorised
  2. Authorised
  3. Authorised
  4. Authorised
TRIAL APPLICATIONS

Submission, decision and country state remain separate

IN

INITIAL

Authorised
Trial status
Authorised
Submitted
22 April 2024
Decided
17 June 2024

Decisions17 June 2024 · Authorized

Country statusFrance · Authorised

SM-1

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
16 May 2025
Decided
22 August 2025

Decisions22 August 2025 · Authorized

Country statusFrance · Authorised

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

  1. Application Submitted

    Application IN · Authorised

  2. Country Assessment

    France · Application IN · Authorized

  3. Application Status

    Application IN · Authorised

  4. Country Decision

    France · Application IN · Authorized

  5. Application Submitted

    Application SM-1 · Authorised

  6. Country Assessment

    France · Application SM-1 · Authorized

  7. Application Status

    Application SM-1 · Authorised

  8. Country Decision

    France · Application SM-1 · Authorized

  9. Trial Status Observed

    Authorised

Observed by i6eal
First observed
23 Jul 2026, 13:19
Last observed
23 Jul 2026, 15:03
Materially modified
23 July 2026
RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓
i6eal (2026): EU AI Studies Monitor, CTIS trial 2024-513248-27-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2024-513248-27-00/
Related tools

Useful next steps

These tools complement the current result.

View all tools
MonitorEU AI medical-device lifecycle monitorWhich medical devices name AI explicitly? Inspect exact text evidence in the official EUDAMED software corpus by manufacturer, risk class, version and registry status—without inferring AI or conformity from software alone.IndexAI innovation pathFollow evidence-backed links from EU funding to reported research outputs—and see exactly where patents or procurement cannot yet be joined safely.IndexAI knowledge flowWhere does knowledge from publicly funded AI projects travel? Follow exact DOI links to citing works, countries, sectors and institutions, with coverage stated explicitly.