Clinical trial · Interventional
Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry
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
NCT05161026CI-TRIAL-00055545REMODALLOnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloid Leukemia, Acute | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone osteodensitometry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patients with AML
- description
- Patients with AML
- interventionNames
- Other: Bone osteodensitometry
Primary outcomes (1)
- measure
- bone mineral density evaluation
- timeFrame
- change over time between diagnostic, transplant, 6 months and 12 months post-transplant
- description
- bone mineral density evaluation post-transplant
Secondary outcomes (4)
- measure
- bone mineral density evaluation
- timeFrame
- change over time between 24 months and 36 months post-transplant
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.