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

NCT05161026 | Not Yet Recruiting

• 1 other identifier: 19-047
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Myeloid Leukemia, Acute

Keywords

allo-HSCTs transplant; osteoporosis

Outcome Measures

Primary Outcomes (1)

• bone mineral density evaluation

  bone mineral density evaluation post-transplant

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

Secondary Outcomes (4)

• bone mineral density evaluation

  change over time between 24 months and 36 months post-transplant

• Bone architectural abnormalities and fracture risk

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

• bone remodeling markers

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

• Pain evaluation

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

Study Arms (1)

Patients with AML

OTHER

Patients with AML

Other: Bone osteodensitometry

Interventions

Bone osteodensitometry OTHER

Evaluation of bone osteodensitometry

Patients with AML

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (4)

Chu Amiens

Amiens, 80054, France

Location

CHU CAEN

Caen, 14033, France

Location

Chu Lille

Lille, 59000, France

Location

Chu Rouen

Rouen, 76038, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Osteoporosis

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Agathe FARGE, PhD

CONTACT

+33 2.31.27.21.40; farge-a@chu-caen.fr

DRCI secretary

CONTACT

+33.2.31.06.57.81; drci-sec@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: December 16, 2021
• Study Start: December 10, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)