Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry

Официальное название

Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry Coupled With FRAX / TBS in Allo-HSCT

Обзор

Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.

Подробное описание

Allo-HSCTs performed for the treatment of hematologic malignancies has been increasing in recent years. There is therefore a growing interest in the quality of life of these patients and in particular for the bone complications of the transplant. Indeed, it was found a high incidence of osteoporosis / osteopenia in this population associated with an increased risk of osteoporotic fracture from 6 to 9 times compared to the general population.

This study will evaluate the variation of mineral density and bone microarchitecture parameters by bone densitometry with measurement of trabecular bone score and fracturing risk before and after allogeneic HSCTs transplant, at predefined times. It's also evaluating pain scale, fracture incidence and bone remodeling markers.

Вмешательства

• Другое Bone osteodensitometry
  Evaluation of bone osteodensitometry

Первичные конечные точки

• bone mineral density evaluation [Срок оценки: change over time between diagnostic, transplant, 6 months and 12 months post-transplant]

Вторичные конечные точки (4)

• bone mineral density evaluation [Срок оценки: change over time between 24 months and 36 months post-transplant]
• Bone architectural abnormalities and fracture risk [Срок оценки: change over time between diagnostic, transplant, 6 months and 12 months post-transplant]
• bone remodeling markers [Срок оценки: change over time between diagnostic, transplant, 6 months and 12 months post-transplant]
• Pain evaluation [Срок оценки: change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant]

Критерии участия

Критерии включения

• Cytological diagnosis of acute myeloid leukemia (AML) with indication for a first-line allo-HSCTs transplant
• Patient affiliated to the social security system
• For women of childbearing age, use of reliable contraception throughout the study in accordance with the CPR of the drugs used.
• The patient must be able to comply with study visits and per protocol procedures
• Patient who has been informed of the study and has signed his informed consent

Критерии исключения

• Person under guardianship or curatorship, or unable to understand the purpose of the study.
• Hematologic malignancies other than AML
• History of neoplasia with bone involvement (sarcoma, multiple myeloma, metastasis...) and/or any solid cancer less than 5 years old
• History of fracture of the femoral neck prior to the diagnosis of hematologic malignancies
• Known bone involvement related to AML at diagnosis
• Primary or secondary osteoporosis known to the diagnosis of hematologic malignancies
• Corticotherapy > 3 months at a dose > 7.5mg/day prior to the diagnosis of hematological disease
• Autograft or anterior allograft
• Pathologies influencing bone metabolism: known inflammatory rheumatism (rheumatoid arthritis, ...), primary hyperparathyroidism, chronic renal failure (GFR < or = at 30ml / min / 1.73m2)
• Pregnant or lactating woman

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 4 центра

• Chu Amiens — Amiens
• CHU CAEN — Caen
• Chu Lille — Lille
• Chu Rouen — Rouen

Идентификаторы

NCT: NCT05161026 · 19-047

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗