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Идёт набор NCT06457776

Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs

— Наблюдательное Osteonecrosis of the Jaw Osteonecrosis Due to Drugs, Jaw Osteonecrosis Due to Drug Bisphosphonate-Associated Osteonecrosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dental management.
Кому может быть актуально
Состояния в реестре: Osteonecrosis of the Jaw, Osteonecrosis Due to Drugs, Jaw, Osteonecrosis Due to Drug, Bisphosphonate-Associated Osteonecrosis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs: a Cohort Prospective Study

Обзор

The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.

Подробное описание

Antiresorptive drugs are widely used for the prevention and treatment of numerous diseases involving the skeletal system. In particular, they have been shown to be effective in reducing the incidence of skeletal events in oncohematologic patients.

Specifically, bone represents a highly affected site of metastatic cancer (i.e., bone metastases from solid tumors of various origins--breast, prostate, renal; multiple myeloma). In the United States, approximately 400,000 individuals suffer from bone metastasis. The most frequent skeletal complications in patients with bone metastases (referred to as SRE - skeletal-related events - in the international literature) include pathologic fractures, spinal cord compression, malignant hypercalcemia, and the need to undergo radiation therapy or surgery on the bone lesion.The introduction of anti-bone resorption drugs (bisphosphonates and denosumab) has reduced the rate of skeletal complications by 30-50% so they are indicated in the management of the oncohematology patient.

The objective of this prospective observational study is to investigate the incidence of Medication Related Osteonecrosis of the Jaws (MRONJ) in patients receiving antiresorptive drugs for oncohematologic reasons during a 5-year follow-up. Secondary objectives are to compare the different antiresorptive drugs in relation to the incidence of MRONJ and to identify any systemic as well as local risk factors.

Вмешательства

  • Процедура Dental management
    The oral conditions of the included patients will be evaluated at baseline. When indicated, dental extractions will be performed before the beginning of Antiresorptive Therapy. Patients will then receive a six-months intervals follow-up, during which primary and secondary prevention of dental diseases will be performed.

Первичные конечные точки

  • Medication Related OsteoNecrosis of the Jaws [Срок оценки: Five years after the beginning of AR therapy]

Критерии участия

Критерии включения

  • Patients with specific prescription to initiate therapy with antiresorptive drugs

Критерии исключения

  • Previous Head and Neck Radiotherapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Cosimo Rupe — Roma

Публикации

  • Rupe C, Gioco G, Tranfa M, Scilla F, Schiavelli A, Cairo F, Galli J, Scambia G, Rengo C, Lajolo C. Differences in oral health status between cancer patients: a case-control observational study. BMC Oral Health. 2025 Dec 1;25(1):1862. doi: 10.1186/s12903-025-06963-7. PMID 41327109

Идентификаторы

NCT: NCT06457776 · MRONJ-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗