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

Myeloid Leukemia, Acute Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05161026
• Other study ID #: 19-047
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: December 1, 2027

Study information

• Verified date: December 2021
• Source: University Hospital, Caen
• Contact: Agathe FARGE, PhD
• Phone: +33 2.31.27.21.40
• Email: farge-a[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Myeloid, Acute
• Myeloid Leukemia, Acute

Intervention

Other:
• Bone osteodensitometry
Evaluation of bone osteodensitometry

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	CHU CAEN	Caen
France	Chu Lille	Lille
France	Chu Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density evaluation	bone mineral density evaluation post-transplant	change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Secondary	bone mineral density evaluation	long term bone mineral density evaluation	change over time between 24 months and 36 months post-transplant
Secondary	Bone architectural abnormalities and fracture risk	evaluation of bone architectural abnormalities and fracture risk	change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Secondary	bone remodeling markers	Dosage of bone remodeling markers	change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Secondary	Pain evaluation	Pain evaluation (EVA)	change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant