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Not yet recruitingNCT05161026REMODALLOUpdated Dec 16, 2021

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

An interventional study of Bone osteodensitometry in Myeloid Leukemia, Acute, sponsored by University Hospital, Caen. Not yet recruiting at 4 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-12-16.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Myeloid Leukemia, Acute

Keywords

  • allo-HSCTs transplant
  • osteoporosis
03

In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's planned enrollment of 120 is above the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    Patients with AML

    Patients with AML

    Other: Bone osteodensitometry

Interventions

  • OtherBone osteodensitometry

    Evaluation of bone osteodensitometry

06

What researchers measure

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

07

Study locations

4 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05161026
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Dec 16, 2021
Start date
Dec 10, 2021 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Dec 16, 2021

Study contacts

Agathe FARGE, PhD
Contact
farge-a@chu-caen.fr
+33 2.31.27.21.40
DRCI secretary
Contact
drci-sec@chu-caen.fr
+33.2.31.06.57.81

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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