Clinical trial NCT05161026: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myeloid Leukemia, Acute
Keywords: allo-HSCTs transplant
osteoporosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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 outcomes:
measure: bone mineral density evaluation
timeFrame: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Secondary outcomes:
measure: bone mineral density evaluation
timeFrame: change over time between 24 months and 36 months post-transplant
measure: Bone architectural abnormalities and fracture risk
timeFrame: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
measure: bone remodeling markers
timeFrame: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
measure: Pain evaluation
timeFrame: change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Caen
country: France
facility: CHU CAEN
city: Lille
country: France
facility: Chu Lille
city: Rouen
country: France
facility: Chu Rouen
Study officials:
References: