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

Caen University Hospital

Status

Not yet enrolling

Conditions

Myeloid Leukemia, Acute

Treatments

Other: Bone osteodensitometry

Study type

Interventional

Funder types

Other

Identifiers

NCT05161026

19-047

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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