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

NCT ID: NCT05161026

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2027-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Myeloid Leukemia, Acute

Keywords

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allo-HSCTs transplant osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with AML

Patients with AML

Group Type OTHER

Bone osteodensitometry

Intervention Type OTHER

Evaluation of bone osteodensitometry

Interventions

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Bone osteodensitometry

Evaluation of bone osteodensitometry

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Amiens

Amiens, , France

Site Status

CHU CAEN

Caen, , France

Site Status

Chu Lille

Lille, , France

Site Status

Chu Rouen

Rouen, , France

Site Status

Countries

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France

Central Contacts

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Agathe FARGE, PhD

Role: CONTACT

Phone: +33 2.31.27.21.40

Email: [email protected]

DRCI secretary

Role: CONTACT

Phone: +33.2.31.06.57.81

Email: [email protected]

Facility Contacts

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MAROLLEAU Jean-Pierre, MD/PhD

Role: primary

Agathe FARGE, PhD

Role: primary

Isabelle LEGROUX, PhD

Role: primary

Fabrice JARDIN, MD/PhD

Role: primary

Other Identifiers

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19-047

Identifier Type: -

Identifier Source: org_study_id