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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- bone mineral density evaluation
研究概览
简要总结
Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patients with AML
Patients with AML
干预措施: Bone osteodensitometry (Other)
结局指标
主要结局
bone mineral density evaluation
时间窗: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
bone mineral density evaluation post-transplant
次要结局
- bone remodeling markers(change over time between diagnostic, transplant, 6 months and 12 months post-transplant)
- bone mineral density evaluation(change over time between 24 months and 36 months post-transplant)
- Pain evaluation(change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant)
- Bone architectural abnormalities and fracture risk(change over time between diagnostic, transplant, 6 months and 12 months post-transplant)