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Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Multiple Myeloma (MYELOMEFRAGIQUANTI)

Assessment of Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Patients With Multiple Myeloma

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04609150
Enrollment
100
Registered
2020-10-30
Start date
2020-11-30
Completion date
2022-06-30
Last updated
2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, Vertebral Fracture

Keywords

Bone marrow fat, Bone fragility, Fat quantification

Brief summary

Multiple myeloma is a disease that causes increased bone fragility which is often revealed or complicated by vertebral fractures. Invasion of bone marrow by tumor plasma cells leads to bone destruction and reduced fat fraction. The main objective is to assess the correlation between vertebral bone marrow fat fraction and bone fragility represented by a severity score of vertebral fractures. The secondary objective is to assess the correlation with clinical and biological prognostic factors and scores..

Detailed description

Patients treated with vertebroplasty will be included during the period of the study, retrospectively or prospectively. Mains collected data are represented by : * Bone marrow fat fraction determined by MRI * Severity score for vertebral fractures * Clinical prognostic factors * Biological prognostic factors * Clinico-biological scores Descriptive statistics and correlation analyses will be performed between the measured parameters.

Interventions

OTHERBone marrow fat quantification by MRI

Bone marrow fat quantification by MRI at the moment of the diagnosis of vertebral fracture before treatment by vertebroplasty

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients followed for multiple myelomas in the Lariboisière/Saint-Louis/Fernand-Widal hospital group * vertebral fractures treated by vertebroplasty from January 2017 to December 2021 * recent clinical and biological data available at the time of imaging and fracture events

Exclusion criteria

* Factors modifying the bone marrow fat fraction (extensive radiotherapy) * Lack of recent clinical or biological data compared to imaging examinations

Design outcomes

Primary

MeasureTime frameDescription
Percentage of bone marrow fat in vertebral bone marrowAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyMeasured from Dixon sequences on MRI exams performed in routine care, for the assessment of the relationship between bone marrow vertebral fat content and the severity of the vertebral fractures
Vertebral fracture severity scoreAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyScore established according to morphological criteria determined by MRI/computerized tomography scan, based on the Genant classification. Calculation of sum of the points awarded as follows: vertebral fracture on osteolytic lesion = 3; osteolytic lesion with high fracture risk = 0; other fracture related to increased bone fragility, scale 1-3 according to Genant's criteria, 3 representing the worst situation; normal vertebra = 0.

Secondary

MeasureTime frameDescription
Weight/body mass index (BMI)At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyThe Body Mass Index is calculated as the ratio between the weight measured in kilograms and the square of the height measured in meters
Age at the moment of the vertebral fractureAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyAge in years at the moment of the vertebral fracture
Type of the monoclonal componentAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyCorresponding the type of the heavy (IgG, IgA, IgD, IgE or IgM) and/or the light chain (κ or λ) of the monoclonal immunoglobulin protein
Serum rate of the monoclonal componentAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastySerum rate of the monoclonal immunoglobulin protein in g/L
Medullary plasmacytosisAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyPercentage of plasma cells assessed by bone marrow aspiration
Presence of anaemiaAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyDefined by hemoglobin value \< 100g/L
Presence of hypercalcemiaAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyDefined by serum calcium \> 2.75mmol/L
SexAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyMale or female
Presence of amyloidosisAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyPresence of amyloid deposits revealed by tissue biopsy
Multiple myeloma stage according to the Salmon-Durie staging SystemAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyThe Salmon-Durie classification in three stages according to the absence (I) or the presence (III) of the following criteria: anemia (hemoglobin value \< 100g/L); hypercalcemia (serum calcium \> 2.75mmol/L); amyloidosis (amyloid deposits revealed by biopsy); bone lesion at imaging. Concerning the serum rate of the monoclonal component, IgA \< 30g/L and IgG \< 50 g/L are considered stage I, and IgA \> 50g/L and IgG \> 70 g/L are considered stage III. The intermediate stage II is based on the rate of the blood monoclonal component (from 30 to 50 g/L for IgA and from 50 to 70 g/L for IgG) . The subclassification depends on the absence (A) or the presence of renal failure related to myeloma (B) (defined by creatinine clearance \< 40mL/min or serum creatinine \> 177µmol/L).
Multiple myeloma stage according to the International Staging System (ISS)At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyTo determine the International Staging System score (ISS) in three stages with stage I corresponding to serum beta-2-microglobulin \< 3.5 mg/L and serum albumin ≥ 35 g/L, stage III corresponding to beta-2-microglobulin ≥ 5.5 mg/L, and stage II when not stage I or III
Serum rate of Lactate dehydrogenaseAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyMeasured in U/L; serum lactate dehydrogenase is a poor prognosis factor when elevated (\> 300U/L)
Salmon-Durie Plus classificationAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyBased of the MRI pattern of multiple myeloma that determine three stages : stage I (0-4 focal lesions), stage II (5-20 focal lesions), stage III (\>20 focal lesions). The subclassification depends on the absence (A) or the absence of extramedullary disease (B) (anemia, hypercalcemia, renal failure, amyloidosis)
Type of bone damage on CT scanAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyClassified as normal, focal lesion, diffuse osteopenia, focal lesion with diffuse osteopenia
Vertebral radiodensityAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyMeasured by a CT scan in Hounsfield Units
Presence of renal failure related to myelomaAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyDefined by a creatinine clearance \< 40mL/min or serum creatinine \> 177µmol/L
Age at the diagnosis of multiple myelomaAt the moment of the diagnosis of the vertebral fracture before treatment by vertebroplastyAge in years at the diagnosis of multiple myeloma

Countries

France

Contacts

Primary ContactGregoire ATTANE, MD
gregoire_attane@hotmail.com+33 (0)688595952

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026