Myeloid Leukemia, Acute
Conditions
Keywords
allo-HSCTs transplant, osteoporosis
Brief summary
Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.
Detailed description
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.
Interventions
OTHERBone osteodensitometry
Evaluation of bone osteodensitometry
Sponsors
University Hospital, Caen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density evaluation | change over time between diagnostic, transplant, 6 months and 12 months post-transplant | bone mineral density evaluation post-transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density evaluation | change over time between 24 months and 36 months post-transplant | long term bone mineral density evaluation |
| Bone architectural abnormalities and fracture risk | change over time between diagnostic, transplant, 6 months and 12 months post-transplant | evaluation of bone architectural abnormalities and fracture risk |
| bone remodeling markers | change over time between diagnostic, transplant, 6 months and 12 months post-transplant | Dosage of bone remodeling markers |
| Pain evaluation | change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant | Pain evaluation (EVA) |
Countries
France
Contacts
Primary ContactAgathe FARGE, PhD
Backup ContactDRCI secretary
Outcome results
None listed