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

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

Overview

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

• Other Bone osteodensitometry
  Evaluation of bone osteodensitometry

Primary outcome measures

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

Secondary outcome measures (4)

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 4 centers

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

Identifiers

NCT: NCT05161026 · 19-047

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗