Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Caen

About this trial

Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Bone osteodensitometry

    Other intervention

    Evaluation of bone osteodensitometry

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Patients with AMLOther 1 intervention

Trial outcomes

Primary outcomes

1

bone mineral density evaluation

bone mineral density evaluation post-transplant

Time frame
change over time between diagnostic, transplant, 6 months and 12 months post-transplant

Secondary outcomes

1

bone mineral density evaluation

long term bone mineral density evaluation

Time frame
change over time between 24 months and 36 months post-transplant
2

Bone architectural abnormalities and fracture risk

evaluation of bone architectural abnormalities and fracture risk

Time frame
change over time between diagnostic, transplant, 6 months and 12 months post-transplant
3

bone remodeling markers

Dosage of bone remodeling markers

Time frame
change over time between diagnostic, transplant, 6 months and 12 months post-transplant
4

Pain evaluation

Pain evaluation (EVA)

Time frame
change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant

Other outcomes

Sponsors and contacts

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