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NCT Number: NCT05161026

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone osteodensitometry

Other

Evaluation of bone osteodensitometry

Primary outcomes

  1. bone mineral density evaluation

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

    bone mineral density evaluation post-transplant

Secondary outcomes

  1. bone mineral density evaluation

    Time frame: change over time between 24 months and 36 months post-transplant

    long term bone mineral density evaluation

  2. Bone architectural abnormalities and fracture risk

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

    evaluation of bone architectural abnormalities and fracture risk

  3. bone remodeling markers

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

    Dosage of bone remodeling markers

  4. Pain evaluation

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

    Pain evaluation (EVA)

Study contacts

Contact information is provided by the study sponsor or research team.

Agathe FARGE, PhD

CONTACT

[email protected]

+33 2.31.27.21.40

DRCI secretary

CONTACT

[email protected]

+33.2.31.06.57.81

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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

Acronym: REMODALLO

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2021
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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