Mediating Role of Myokines in the Dialogue Between Muscle and Bone Tissue in a Population of Healthy Women Aged 20-89 Years
Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Nov 8, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how muscle and bone communicate with each other in healthy women aged 20 to 89 years. Researchers believe that certain substances released by muscles, called myokines, may play an important role in maintaining bone density. This is important because having strong bones reduces the risk of fractures and osteoporosis. The study aims to see how muscle mass affects bone health across different ages and body types.
To participate in this trial, women must be of Caucasian ethnicity and be part of a social security scheme. Some key factors that would make someone ineligible include having a history of bone fractures from minor falls, certain medical conditions affecting bones or muscles, or taking specific medications that can impact bone health. Participants can expect to provide informed consent and may undergo various examinations related to their muscle and bone health. This research could help improve our understanding of how to support bone health in women.
Gender
FEMALE
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 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.
About Centre Hospitalier Universitaire De Nīmes
The Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) is a leading academic medical center located in Nîmes, France, dedicated to advancing healthcare through innovative clinical research and patient care. As a prominent sponsor of clinical trials, CHU Nîmes collaborates with a multidisciplinary team of healthcare professionals and researchers to conduct rigorous studies aimed at improving treatment outcomes and enhancing medical knowledge across various specialties. With a strong commitment to ethical standards and patient safety, CHU Nîmes fosters a research environment that encourages scientific excellence and contributes to the development of new therapies and healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nîmes, , France
Montpellier, , France
Patients applied
Trial Officials
Thibault MURA, Prof.
Study Director
Centre Hospitalier Universitaire de Nīmes
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported