Exploring the Connection Between Muscle and Bone in Healthy Women

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

This study is trying to see how muscle affects bone health in healthy women aged 20 to 89 by looking at muscle strength and bone density.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 20 Years to 89 Years
• Sex: Female
• Sponsor: Centre Hospitalier Universitaire de Nīmes (other)
• Drugs / interventions: Denosumab
• Locations: 2 sites (Montpellier and 1 other locations)
• Trial ID: NCT06683222 on ClinicalTrials.gov

What this trial studies

This study investigates how muscle tissue influences bone density through the secretion of myokines in healthy women aged 20 to 89. It aims to recruit 425 participants from three centers in France and will utilize DXA scans to measure bone mineral density at various sites. The study will also collect blood and saliva samples and conduct physical tests to assess muscle strength. The goal is to develop updated reference curves for bone density and body composition, enhancing our understanding of the relationship between muscle and bone health.

Who should consider this trial

Good fit: Ideal candidates are healthy Caucasian women aged 20 to 89 who meet the inclusion criteria.

Not a fit: Patients with a history of fragility fractures or significant hormonal changes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for maintaining bone health in women as they age.

How similar studies have performed: While the specific approach of this study is novel, previous research has indicated a significant relationship between muscle mass and bone density.

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.

Where this trial is running

Montpellier and 1 other locations

• C.H.R.U. Lapeyronie — Montpellier, France (RECRUITING)
• Chu Nimes — Nîmes, France (RECRUITING)

Study contacts

• Study coordinator: Vincent BOUDOUSQ, Dr

Conditions: Bone Density, Myokines