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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Myeloid Leukemia, Acute
• Intervention / Treatment: Other: Bone osteodensitometry

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agathe FARGE, PhD; Phone Number: +33 2.31.27.21.40; Email: farge-a@chu-caen.fr
• Study Contact Backup: Name: DRCI secretary; Phone Number: +33.2.31.06.57.81; Email: drci-sec@chu-caen.fr

Study Locations

• France
  • Amiens, France, 80054
    • CHU AMIENS
    • Contact: MAROLLEAU Jean-Pierre, MD/PhD; Phone Number: +33 3.22.45.59.20; Email: marolleau.jean-pierre@chu-amiens.fr
  • Caen, France, 14033
    • CHU CAEN
    • Contact: Agathe FARGE, PhD; Phone Number: +33 2.31.27.21.40; Email: farge-a@chu-caen.fr
  • Lille, France, 59000
    • CHU Lille
    • Contact: Isabelle LEGROUX, PhD; Phone Number: +33 3.20.44.59.62; Email: Isabelle.legroux@chru-lille.fr
  • Rouen, France, 76038
    • CHU Rouen
    • Contact: Fabrice JARDIN, MD/PhD; Phone Number: +33 2.32.08.24.51; Email: fabrice.jardin@rouen.fnclcc.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with AML	Other: Bone osteodensitometry; Evaluation of bone osteodensitometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone mineral density evaluation	bone mineral density evaluation post-transplant	change over time between diagnostic, transplant, 6 months and 12 months post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone mineral density evaluation	long term bone mineral density evaluation	change over time between 24 months and 36 months post-transplant
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
bone remodeling markers	Dosage of bone remodeling markers	change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Pain evaluation	Pain evaluation (EVA)	change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Anticipated): December 10, 2021
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: osteoporosis; allo-HSCTs transplant
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 19-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No