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

Sponsor
University Hospital, Caen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05161026
Collaborator
(none)
120
4
1
71.7
30
0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Bone osteodensitometry
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Anticipated Study Start Date :
Dec 10, 2021
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: Patients with AML

Patients with AML

Other: Bone osteodensitometry
Evaluation of bone osteodensitometry

Outcome Measures

Primary Outcome Measures

  1. bone mineral density evaluation [change over time between diagnostic, transplant, 6 months and 12 months post-transplant]

    bone mineral density evaluation post-transplant

Secondary Outcome Measures

  1. bone mineral density evaluation [change over time between 24 months and 36 months post-transplant]

    long term bone mineral density evaluation

  2. Bone architectural abnormalities and fracture risk [change over time between diagnostic, transplant, 6 months and 12 months post-transplant]

    evaluation of bone architectural abnormalities and fracture risk

  3. bone remodeling markers [change over time between diagnostic, transplant, 6 months and 12 months post-transplant]

    Dosage of bone remodeling markers

  4. Pain evaluation [change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant]

    Pain evaluation (EVA)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Amiens Amiens France 80054
2 CHU CAEN Caen France 14033
3 Chu Lille Lille France 59000
4 Chu Rouen Rouen France 76038

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT05161026
Other Study ID Numbers:
  • 19-047
First Posted:
Dec 16, 2021
Last Update Posted:
Dec 16, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Caen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2021