Myeloid Leukemia, AcuteREMODALLONCT05161026
Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry
A study testing Bone osteodensitometry in people with Myeloid Leukemia, Acute, run by University Hospital, Caen at 4 sites in France.
Trial summary
Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myeloid Leukemia, Acute
- What is being tested?
- Bone osteodensitometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 10 Dec 2021to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Chu Amiens
Amiens, 80054
MAROLLEAU Jean-Pierre, MD/PhD, +33 3.22.45.59.20, marolleau.jean-pierre@chu-amiens.fr
CHU CAEN
Caen, 14033
Agathe FARGE, PhD, +33 2.31.27.21.40, farge-a@chu-caen.fr
Chu Lille
Lille, 59000
Isabelle LEGROUX, PhD, +33 3.20.44.59.62, Isabelle.legroux@chru-lille.fr
Chu Rouen
Rouen, 76038
Fabrice JARDIN, MD/PhD, +33 2.32.08.24.51, fabrice.jardin@rouen.fnclcc.fr
About this study
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
Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.
Read the 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.
- Conditions
- Myeloid Leukemia, Acute
- Being tested
- Bone osteodensitometry
- Keywords
- allo-HSCTs transplant, osteoporosis
- Medical subject headings
- Leukemia, Myeloid, Acute, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone osteodensitometryOther
Evaluation of bone osteodensitometry
| Study group | Role | What they receive |
|---|---|---|
| Patients with AML | Other | Patients with AML Receives: Other: Bone osteodensitometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density evaluation
bone mineral density evaluation post-transplant
Measured: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Secondary outcomes (4)
bone mineral density evaluation
long term bone mineral density evaluation
Measured: 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
Measured: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
bone remodeling markers
Dosage of bone remodeling markers
Measured: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Pain evaluation
Pain evaluation (EVA)
Measured: change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start10 Dec 2021 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid Leukemia, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161026
- Sponsor's protocol ID
- 19-047
- Acronym
- REMODALLO
- Status last verified
- Dec 2021
- First submitted
- 13 Jul 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05161026
- Acronym / sponsor ID
- REMODALLO / 19-047
- Conditions
- Myeloid Leukemia, Acute
- Keywords
- allo-HSCTs transplant, osteoporosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 10 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with AML | Other | Other: Bone osteodensitometryPatients with AML |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone osteodensitometryEvaluation of bone osteodensitometry | Other | Patients with AML |
Primary outcome
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
4 secondary outcomes
bone mineral density evaluation
Time frame: change over time between 24 months and 36 months post-transplant
Bone architectural abnormalities and fracture risk
Time frame: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
bone remodeling markers
Time frame: change over time between diagnostic, transplant, 6 months and 12 months post-transplant
Pain evaluation
Time frame: change over time between diagnostic, transplant, 6 months, 12 months, 24 months and 36 months post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone osteodensitometry in people with Myeloid Leukemia, Acute, run by University Hospital, Caen at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agathe FARGE, PhD (+33 2.31.27.21.40, farge-a@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density evaluation (time frame: change over time between diagnostic, transplant, 6 months and 12 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.