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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University Hospital, Caen
- Enrollment
- 120
- Locations
- 8
- Primary Endpoint
- bone mineral density evaluation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
bone mineral density evaluation
Time Frame: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
bone mineral density evaluation post-transplant
Secondary Outcomes
- bone remodeling markers(change over time between diagnostic, transplant, 6 months and 12 months post-transplant)
- bone mineral density evaluation(change over time between 24 months and 36 months post-transplant)
- Pain evaluation(change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant)
- Bone architectural abnormalities and fracture risk(change over time between diagnostic, transplant, 6 months and 12 months post-transplant)