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ClinicalTrials.gov ID

NCT05161026

Lead Sponsor

University Hospital, CaenOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

120Estimated

Last Update Posted

Dec 16, 2021Actual

Start Date

Dec 10, 2021Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2027Estimated

Official Title

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

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.

• Myeloid Leukemia, Acute

• Bone osteodensitometry

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Other

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, CaenOTHER

farge-a@chu-caen.fr+33 2.31.27.21.40

Isabelle.legroux@chru-lille.fr+33 3.20.44.59.62

fabrice.jardin@rouen.fnclcc.fr+33 2.32.08.24.51