Mediating Role of Myokines in the Dialogue Between Muscle and Bone Tissue in a Population of Healthy Women Aged 20-89 Years
Recruiting
N/AInterventional Study
Bone Density
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
20 – 89
Sex
Female
Study type
Interventional
Purpose
Basic Science
Participants needed
280 (estimated)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Other
Who this trial is looking for
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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.
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Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
* Hip fracture in a first-degree relative.
Patients with any of the following pathologies affecting bone, muscle or adipose tissue:
* Inflammatory bowel disease (IBD: Crohn's disease, ulcerative colitis) and untreated celiac disease.
* Renal insufficiency on dialysis or patients with nephrology follow-up.
* Known hypercalciuria.
* Osteomalacia, rickets, osteogenesis imperfecta.
* Osteopathy (Paget's disease, osteopetrosis, etc.).
* Chronic inflammatory rheumatism.
* Hemopathy, neoplasia.
* Hepatic insufficiency or chronic hepatitis.
* Endocrinopathy: diabetes, dysthyroidism, hypogonadism, hypercorticism, untreated acromegaly.
* Anorexia nervosa.
* Hyperparathyroidism (even controlled).
* History of digestive surgery (bariatric, gastrectomy, digestive resection other than appendectomy, etc.).
* History of organ transplantation.
* Chronic infectious disease (HIV, etc.).
* Weight loss of more than 10 kg within 6 months.
* Paresis, marked lameness or unloading of a limb, or prolonged immobilization of more than one month in the last 12 months.
* Patients on treatments that may affect bone mass or body composition:
* Biphosphonates (Alendronate (Fosamax® and generics), Risedronate (Actonel® and generics), Zoledronate (Aclasta® and generics).
* Teriparatide (Forsteo®).
* Denosumab (Prolia®)
* Selective estrogen receptor modulators (Clomifene, Tamoxifene, Toremifene, Raloxifene).
* Anabolic steroids.
* Strontium ranelate.
* Carbamazepine.
* Phenobarbital.
* Immunosuppressants.
* Patients on anti-epileptics.
* Patients with any of the following abnormalities in the measurement area:
* Major deformities of the wrist, hip or vertebrae.
* Compression of vertebral bodies, cementoplasty.
* Prosthesis, implant (breast, buttock, etc.), foreign body.
* Hip paraosteoarthropathy.
* Injection of radiological contrast medium, barium enema, nuclear medicine examination within 10 days.
* Intensive sport (more than 10 h/week).
* Extreme BMI (BMI \< 18, BMI \> 35 kg/m²).
* Loss of autonomy.
* People with neurodegenerative disorders affecting their ability to give consent.
* Pregnant, parturient or breast-feeding women.
* Participation in an interventional study involving a drug or medical device or a category 1 RIPH within 3 months prior to inclusion.
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