NCT05161026Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Dec 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 13 Jul 2021
- Start date
- 10 Dec 2021
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- University Hospital, Caen
- Diseases
- Acute myeloid leukemia, Osteoporosis
- NCT number
- NCT05161026
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 10 Dec 2021 to the primary completion date, 1 Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of fracture of the femoral neck prior to the diagnosis of hematologic malignancies
- Corticotherapy \> 3 months at a dose \> 7.5mg/day prior to the diagnosis of hematological disease
Other illness
- Hematologic malignancies other than AML
- Primary or secondary osteoporosis known to the diagnosis of hematologic malignancies
Lab values
- Pathologies influencing bone metabolism: known inflammatory rheumatism (rheumatoid arthritis, ...), primary hyperparathyroidism, chronic renal failure (GFR \< or = at 30ml / min / 1.73m2)
Age
- History of neoplasia with bone involvement (sarcoma, multiple myeloma, metastasis...) and/or any solid cancer less than 5 years old
Other
- Person under guardianship or curatorship, or unable to understand the purpose of the study.
- Known bone involvement related to AML at diagnosis
- Autograft or anterior allograft
- Pregnant or lactating woman
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.