Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry (REMODALLO)
Primary Purpose
Myeloid Leukemia, Acute
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bone osteodensitometry
Sponsored by
About this trial
This is an interventional other trial for Myeloid Leukemia, Acute focused on measuring allo-HSCTs transplant, osteoporosis
Eligibility Criteria
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
Sites / Locations
- Chu Amiens
- CHU CAEN
- Chu Lille
- Chu Rouen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with AML
Arm Description
Patients with AML
Outcomes
Primary Outcome Measures
bone mineral density evaluation
bone mineral density evaluation post-transplant
Secondary Outcome Measures
bone mineral density evaluation
long term bone mineral density evaluation
Bone architectural abnormalities and fracture risk
evaluation of bone architectural abnormalities and fracture risk
bone remodeling markers
Dosage of bone remodeling markers
Pain evaluation
Pain evaluation (EVA)
Full Information
NCT ID
NCT05161026
First Posted
July 13, 2021
Last Updated
December 6, 2021
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT05161026
Brief Title
Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry
Acronym
REMODALLO
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 10, 2021 (Anticipated)
Primary Completion Date
December 1, 2026 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloid Leukemia, Acute
Keywords
allo-HSCTs transplant, osteoporosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with AML
Arm Type
Other
Arm Description
Patients with AML
Intervention Type
Other
Intervention Name(s)
Bone osteodensitometry
Intervention Description
Evaluation of bone osteodensitometry
Primary Outcome Measure Information:
Title
bone mineral density evaluation
Description
bone mineral density evaluation post-transplant
Time Frame
change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Secondary Outcome Measure Information:
Title
bone mineral density evaluation
Description
long term bone mineral density evaluation
Time Frame
change over time between 24 months and 36 months post-transplant
Title
Bone architectural abnormalities and fracture risk
Description
evaluation of bone architectural abnormalities and fracture risk
Time Frame
change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Title
bone remodeling markers
Description
Dosage of bone remodeling markers
Time Frame
change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Title
Pain evaluation
Description
Pain evaluation (EVA)
Time Frame
change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agathe FARGE, PhD
Phone
+33 2.31.27.21.40
Email
farge-a@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
DRCI secretary
Phone
+33.2.31.06.57.81
Email
drci-sec@chu-caen.fr
Facility Information:
Facility Name
Chu Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MAROLLEAU Jean-Pierre, MD/PhD
Phone
+33 3.22.45.59.20
Email
marolleau.jean-pierre@chu-amiens.fr
Facility Name
CHU CAEN
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agathe FARGE, PhD
Phone
+33 2.31.27.21.40
Email
farge-a@chu-caen.fr
Facility Name
Chu Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle LEGROUX, PhD
Phone
+33 3.20.44.59.62
Email
Isabelle.legroux@chru-lille.fr
Facility Name
Chu Rouen
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice JARDIN, MD/PhD
Phone
+33 2.32.08.24.51
Email
fabrice.jardin@rouen.fnclcc.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry
We'll reach out to this number within 24 hrs