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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
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

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Amiens
Coordinator of this site? Confirm its status
AmiensFranceUnknown status
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceUnknown status
CHU Lille
Coordinator of this site? Confirm its status
LilleFranceUnknown status
CHU Rouen
Coordinator of this site? Confirm its status
RouenFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.