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New treatment option for Bone Density
Official title Mediating Role of Myokines in the Dialogue Between Muscle and Bone Tissue in a Population of Healthy Women Aged 20-89 Years
ClinicalTrials.gov ID: NCT06683222
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 89, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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).
- 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...
- 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 \ 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 treatment study involving a drug or medical device or a category 1 RIPH within 3 months prior to inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
- Nîmes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 89 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France; Nîmes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.