{
  "id": "ctis:2024-513248-27-00",
  "euct": "2024-513248-27-00",
  "title": "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)",
  "publicTitle": "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)",
  "fullTitle": "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)",
  "shortTitle": "ZOSTER ICO-N-2018-14",
  "status": "Authorised",
  "statusCode": "4",
  "startDateEU": "2020-07-20",
  "decisionDate": "2024-06-17T17:55:31.466",
  "publishDate": "2025-08-23T03:35:22.494162262",
  "trialRegion": "EEA",
  "trialRegionCode": "1",
  "medicalConditions": [
    {
      "name": "Patients, men or women over 18 old, with inoperable vertebral bone metastases who must beneficit treatment with stereotactic radiotherapy",
      "rareDisease": false
    }
  ],
  "therapeuticAreas": [
    {
      "code": "4",
      "name": "Diseases [C] - Neoplasms [C04]"
    }
  ],
  "trialCategory": {
    "phaseCode": "5",
    "categoryCode": "2",
    "lowIntervention": false
  },
  "duration": {
    "estimatedRecruitmentStartDate": "2020-06-23",
    "estimatedEndDate": "2027-06-23",
    "estimatedGlobalEndDate": null
  },
  "countries": [
    {
      "name": "France",
      "publicStatusCode": "4",
      "firstDecisionDate": "2024-06-17T17:55:31.466",
      "lastDecisionDate": "2025-08-22T13:17:04.856",
      "history": [
        {
          "source": "application_country_status",
          "applicationBusinessKey": "IN",
          "applicationType": "INITIAL",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2024-06-11",
          "date": "2024-06-17",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        },
        {
          "source": "application_country_status",
          "applicationBusinessKey": "SM-1",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-07-04",
          "date": "2024-06-17",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        },
        {
          "source": "application_decision",
          "applicationBusinessKey": "IN",
          "applicationType": "INITIAL",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "date": "2024-06-17T17:55:31.466",
          "isRMS": true
        },
        {
          "source": "application_decision",
          "applicationBusinessKey": "SM-1",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "status": "Authorised",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "date": "2025-08-22T13:17:04.856",
          "isRMS": true
        }
      ]
    }
  ],
  "applications": [
    {
      "id": "application:2024-513248-27-00:in",
      "businessKey": "IN",
      "type": "INITIAL",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2024-04-22",
      "decisionDate": "2024-06-17",
      "decisions": [
        {
          "mscName": "France",
          "decisionDate": "2024-06-17T17:55:31.466",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "applicationType": "INITIAL",
          "isRMS": true
        }
      ],
      "countryStatuses": [
        {
          "countryName": "France",
          "mscName": "France",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "decisionDate": "2024-06-17",
          "firstDecisionDate": "2024-06-17",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2024-06-11",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        }
      ]
    },
    {
      "id": "application:2024-513248-27-00:sm-1",
      "businessKey": "SM-1",
      "type": "SUBSTANTIAL MODIFICATION",
      "status": "Authorised",
      "trialStatus": "Authorised",
      "submissionDate": "2025-05-16",
      "decisionDate": "2025-08-22",
      "decisions": [
        {
          "mscName": "France",
          "decisionDate": "2025-08-22T13:17:04.856",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
          "eventType": "decision",
          "applicationType": "SUBSTANTIAL MODIFICATION",
          "isRMS": true
        }
      ],
      "countryStatuses": [
        {
          "countryName": "France",
          "mscName": "France",
          "trialStatus": "Authorised",
          "decision": "authorized",
          "decisionDate": "2024-06-17",
          "firstDecisionDate": "2024-06-17",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-07-04",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        }
      ]
    }
  ],
  "evidence": [
    {
      "id": "evidence:ae6a1197ae82747da71665ae",
      "path": "authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[10].secondaryObjective",
      "term": "deep learning",
      "snippet": "Determination by deep learning of a predictive model for the occurrence of a bone fracture at 1 year based on imaging examinations."
    }
  ],
  "official": {
    "retrieveUrl": "https://euclinicaltrials.eu/ctis-public-api/retrieve/2024-513248-27-00",
    "publicUrl": "https://euclinicaltrials.eu/ctis-public/view/2024-513248-27-00?lang=en"
  },
  "slug": "2024-513248-27-00",
  "firstObservedAt": "2026-07-23T11:19:41.794Z",
  "lastObservedAt": "2026-07-23T13:03:56.000Z",
  "dateModified": "2026-07-23",
  "materialFingerprint": "0f5350ca83eeec359c8f15ae287873fe5656aa6c506db3d95ca55c185573e333"
}