Mediating Role of Myokines in the Dialogue Between Muscle and Bone Tissue in a Population of Healthy Women Aged 20-89 Years

ConditionBone Density
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-89
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

The main hypothesis is that muscle acts on bone tissue via the secretion of myokines (myostatin, follistatin, irisin). This is based on previous results showing that muscle mass in different patient populations with very different body mass indexes (anorexic or obese patients) is significantly and independently associated with bone mineral density.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Self-reported Caucasian ethnicity (Europe, Middle East, North Africa) only as there is a difference in BMD by ethnicity.

Person affiliated with or benefiting from a social security scheme.

Free, informed consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Disqualifiers

Fragility fracture defined as a spontaneous or low-kinetic fracture (≤ one fall from height).

Early menopause (< 40 years), hysterectomy (complete < 40 years), primary amenorrhea (absence of menstruation before 15 years), current amenorrhea of more than 3 months without contraceptive if the patient is less than 40 years old.

Patients on treatments: prolonged corticosteroid therapy > 3 months or > 1 g (cumulative dose).

Immobilization of more than 3 months, less than 12 months old.

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood sample

    Diagnostic test

    36 ml of blood in 3 x 7 ml dry tubes, 1 x 5 ml EDTA tube, 1 x 5 ml heparinized tube, 1 x 5 ml anti-protease tube)

  • Saliva sample

    Diagnostic test

    5 ml of saliva will be taken.

  • Grip test

    Diagnostic test

    The grip strength of the dominant arm will be measured with the participant in a standing position, with the arm close to the body and the elbow at 90◦ flexion, while the non-dominant arm will be positioned alongside the body. Three measurements will be taken for the dominant hand, and the mean value will be calculated and used for analysis. One minute is allowed between each repetition, to avoid muscle fatigue. Dynamometer quality control is ensured by regularly checking known resistance values.

  • MicroFET2® maximum isometric force test

    Other intervention

    The microFET2 device is used to test isometric force. The microFET2 dynamometer is battery-powered and ergonomically designed to fit in the palm of the hand. The system is microprocessor-controlled to provide accurate, repeatable muscle force readings. The microFET Clinical software automatically performs calculations and validity tests, and allows graphs to be generated from the data, enabling reports of different patient tests to be compared

  • Maximum isometric knee extension bench test.

    Other intervention

    The maximal isometric knee extension strength test on a specially-adapted strength bench consists in performing 3 maximal contractions with 1 minute's rest between each test.

  • The SPPB (Short Physical Performance Battery)

    Other intervention

    Battery of tests comprising a balance test, a walking speed test and a chair-lift test

  • The 6-minute walking test.

    Other intervention

    Muscular function will be determined by the 6-minute walk test to assess aerobic endurance. Participants will be asked to walk for 6 min as fast as possible on a shuttle track. The distance (m) covered in 6 min will be measured. Walking speed (m/s) will be calculated as the distance (m) covered in 6 min. A walking speed \<0.8 m/s has been defined as a low value.

  • Segmental impedancemetry examination.

    Other intervention

    Segmental impedancemetry involves measuring body composition using the body's resistance to the passage of a low-intensity electric current. This test is harmless to the body.

  • Indirect calorimetry test.

    Other intervention

    An Indirect calorimetry is the standard method for measuring energy expenditure at rest. It is based on the principle that the human body burns nutrients using O2 and producing CO2.

  • Fardellone's questionnaire

    Other intervention

    Completion of a questionnaires on calcium intake (Fardellone)

  • ONAPS questionnaire

    Other intervention

    The ONAPS questionnaire contains questions on physical activity and sedentariness

  • Dietary intake.questionnaire

    Other intervention

    The dietary intake questionnaire contains questions regarding the person's eating habits - how many meals a day, where they eat, whether they eat alone, what foods they eat/drink and whether they are following a particular diet and, if so, the reasons why.

Treatment groups

280 Participants
are divided into 1 treatment group
Group A: Sub-group of 280 patients derived from the MONIKA studyOther 12 interventions

Trial outcomes

Primary outcomes

1

Myostatin

Plasma concentration of myostatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay

Time frame
Baseline
2

Follistatin

Plasma concentration of follistatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay

Time frame
Baseline
3

Irisin

Plasma concentration of irisin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay

Time frame
Baseline
4

Bone Mineral Density

Bone densitometry using X-ray absorptiometry (DXA) measured in g/cm²

Time frame
Baseline

Secondary outcomes

1

Leptin

Plasma concentration of leptin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay

Time frame
Baseline
2

Adiponecotin

Plasma concentration of adiponecotin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay

Time frame
Baseline
3

Fat mass

Impedencemetry, measured in Kg

Time frame
Baseline
4

Bone mineral density: impedencemetry

Bone densitometry will be measured by impedencemetry in g/cm²

Time frame
Baseline

Other outcomes

1

Creation of a blood bank

Blood samples will be stored at the biological resource centers of Nîmes and Montpellier University Hospitals. As soon as the samples have been taken, the tubes are left at room temperature for about 5 minutes to coagulate (only dry tubes will coagulate). They are then centrifuged at 3800 rpm for 20 minutes at 4°C, aliquoted into cryotubes (volume 600 µl) and frozen as quickly as possible at -80°C.

Time frame
Baseline
2

Creation of a saliva bank

The saliva sample is taken at least 60 minutes after brushing the teeth or taking medication and at least 10 minutes after drinking (water). The subject must place the cotton swab in the mouth without touching it and leave it in the mouth for at least 3 minutes until he or she can no longer avoid swallowing the saliva produced. The subject then returns the inhibited saliva swab to the suspended container and seals the tube with the stopper. The tube was then centrifuged at 3800 rpm for 20 minutes at 4°C. The clear saliva (without residue) thus extracted is aliquoted into cryotubes (volume 600 µl) and frozen as quickly as possible at -80°C. Saliva samples will be stored at the biological resource centers of Nîmes and Montpellier University Hospitals.

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.