Clinical trial NCT04609150: Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Multiple Myeloma (MYELOMEFRAGIQUANTI)
Official title: Assessment of Vertebral Fat Quantitative MRI as a Marker of Bone Fragility in Patients With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Vertebral Fracture
Keywords: Bone marrow fat
Bone fragility
Fat quantification
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed for multiple myelomas in the Lariboisière/Saint-Louis/Fernand-Widal hospital group, with vertebral fractures treated by vertebroplasty from January 2017 to December 2021, with recent clinical and biological data available at the time of imaging and fracture events.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of bone marrow fat in vertebral bone marrow
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Vertebral fracture severity score
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Secondary outcomes:
measure: Sex
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Age at the diagnosis of multiple myeloma
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Weight/body mass index (BMI)
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Age at the moment of the vertebral fracture
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Type of the monoclonal component
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Serum rate of the monoclonal component
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Medullary plasmacytosis
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Presence of anaemia
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Presence of hypercalcemia
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Presence of renal failure related to myeloma
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Presence of amyloidosis
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Multiple myeloma stage according to the Salmon-Durie staging System
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Multiple myeloma stage according to the International Staging System (ISS)
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Serum rate of Lactate dehydrogenase
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Salmon-Durie Plus classification
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Type of bone damage on CT scan
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
measure: Vertebral radiodensity
timeFrame: At the moment of the diagnosis of the vertebral fracture before treatment by vertebroplasty
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Lariboisière Hospital, Osteo-Articular, Visceral and Vascular Imaging department
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Valérie BOUSSON, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: