Bone DensityMyOsNCT06683222
Mediating Role of Myokines in the Dialogue Between Muscle and Bone Tissue in a Population of Healthy Women Aged 20-89 Years
A study testing Blood sample, Saliva sample and Grip test in people with Bone Density, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Density
- What is being tested?
- Blood sample, Saliva sample and Grip test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Nov 2024to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
Show all 45Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
C.H.R.U. Lapeyronie
Montpellier, 34295
Denis Mariano Goulart, Pr, +334 64 33 85 98, d-mariano_goulart@chu-montpellier.fr
Denis Mariano Goulart, Pr
- Recruiting
Chu Nimes
Nîmes, 30029
Vincent BOUDOUSQ, Dr, +334.66.68.32.66, vincent.boudousq@chu-nimes.fr
Vincent BOUDOUSQ, Dr
About this study
Official title: 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
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.
Read the detailed description
Bone densitometry using X-ray absorptiometry (DXA) is the reference technique for measuring Bone Mineral Density (BMD). According to the International Osteoporosis Foundation (IOF), if a single site is to be preferred, it should be the total hip or femoral neck, using a single NHANES III reference curve. It should be stressed, however, that this curve was obtained from a North American population with anthropometric parameters, notably body mass index (BMI), that differ from those of the European population, particularly the Caucasian population. Apparently, only one reference curve has been obtained in France, from the OFELY study in 1993. Given the age of this cohort and the possibility of BMI changes over time in the Caucasian population, but even more so, the impossibility of transposing this curve onto new DXAs of different brands, new reference curves need to be developed. DMS IMAGING is therefore financing the MONIKA study, with the CHU de Nîmes as sponsor.
As part of this study, some 425 healthy female volunteers aged between 20 and 89 will be recruited from three centers (Nîmes, Montpellier, Lyon). A DXA examination at various bone sites (femur, rachis, radius and whole body) will provide up-to-date normalcy curves for BMD, but also for body composition (fat and lean mass), which are currently lacking. Access to this population could also enable us to better understand bone physiology and the links that may exist between bone tissue and muscle and fat tissue.For example, the serum concentration of leptin, a hormone secreted by adipose tissue, is associated with bone mass in non-obese women.More recent data show that skeletal muscle also has a secretory activity, characterized by the production of myokines.In humans, there are various arguments in favour of myostatin's action on bone tissue.However, clinical studies in humans are very limited.Through two clinical studies, myokine levels were assessed in two populations with very different BMIs. Female patients suffering from anorexia nervosa, for example, showed decreased myostatin levels, increased follistatin levels and comparable irisin levels, in parallel with very low BMD, compared with a population of young, non-malignant women.
In obese women with high BMD, it was also shown that myostatin and follistatin levels were high, whereas irisin levels were lower than in a control population. Furthermore, the effect of lean body mass on BMD was partially mediated by irisin. These results are still preliminary, having been obtained on a small group of subjects, and merit further investigation on a representative population scale. However, there are apparently no age-dependent reference values for these myokines.
In addition to the involvement of these myokines in the muscle-bone complex, these factors could also be involved in the muscle-fat complex, since new functions are now being attributed to them, such as lipolysis, which could affect the concentrations of certain adipokines, such as leptin, which in turn could have an impact on bone formation and resorption. 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 BMIs (anorexic or obese patients) is significantly and independently associated with BMD.
- Conditions
- Bone Density
- Being tested
- Blood sample, Saliva sample, Grip test, MicroFET2® maximum isometric force test, Maximum isometric knee extension bench test.
- Keywords
- Myokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic 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 sampleDiagnostic test
5 ml of saliva will be taken.
Grip testDiagnostic 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 testOther
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
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
Battery of tests comprising a balance test, a walking speed test and a chair-lift test
The 6-minute walking test.Other
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
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
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 questionnaireOther
Completion of a questionnaires on calcium intake (Fardellone)
ONAPS questionnaireOther
The ONAPS questionnaire contains questions on physical activity and sedentariness
Dietary intake.questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sub-group of 280 patients derived from the MONIKA study | Other | Not described Receives: Diagnostic Test: Blood sample; Diagnostic Test: Saliva sample; Diagnostic Test: Grip test; Other: MicroFET2® maximum isometric force test; Other: Maximum isometric knee extension bench test.; Other: The SPPB (Short Physical Performance Battery); Other: The 6-minute walking test.; Other: Segmental impedancemetry examination.; Other: Indirect calorimetry test.; Other: Fardellone's questionnaire; Other: ONAPS questionnaire; Other: Dietary intake.questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myostatin
Plasma concentration of myostatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Measured: Baseline
Follistatin
Plasma concentration of follistatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Measured: Baseline
Irisin
Plasma concentration of irisin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Measured: Baseline
Bone Mineral Density
Bone densitometry using X-ray absorptiometry (DXA) measured in g/cm²
Measured: Baseline
Lean body mass
Impedencemetry, measured in Kg
Measured: Baseline
Secondary outcomes (18)
Leptin
Plasma concentration of leptin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Measured: Baseline
Adiponecotin
Plasma concentration of adiponecotin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Measured: Baseline
Fat mass
Impedencemetry, measured in Kg
Measured: Baseline
Bone mineral density: impedencemetry
Bone densitometry will be measured by impedencemetry in g/cm²
Measured: Baseline
Grip test
Measured by a digital dynamometer (MicroFET2)
Measured: Baseline
Isometric force
bench test
Measured: Baseline
Walking test
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
Measured: Baseline
Short Physical Performance Battery : Balance test
The person's ability to stand for 10 sec with feet in 3 different positions (together side-by-side, semi-tandem, and tandem) is tested and scored as follows :
- Side-by-side stance scored from 0-1
- Semi-tandem stance scored from 0-1
- Tandem stance scored from 0-2
Measured: Baseline
Short Physical Performance Battery : Walking speed test
Two timed trials of a 3-meter or 4-meter walk (fastest recorded in seconds)
Measured: Baseline
Short Physical Performance Battery : Chair lift test
The time taken to raise a chair 5 times is recorded in seconds.
Measured: Baseline
Plasma concentration of osteocalcin, a bone remodelling marker.
Measured in ng/ml
Measured: Baseline
Plasma concentration of serum cross-linked C-telopeptide of type I collagen (CTX), a bone remodelling marker.
Measured in pmol/l
Measured: Baseline
Calcium intake
Calcium intake (mg/day) will be measured using the Fardellone Dietary intake questionnaire (protein (gr), carbohydrate (gr), fat (gr)) will be assessed using the dietary habits questionnaire.
Measured: Baseline
Level of physical activity
Level of physical activity (hours/week) will be assessed using the Physical Activity and Sedentariness Questionnaire (Observatoire National de l'Activité Physique et se Sédantarité = National Observatory on Physical Activity and Sedentariness).
Measured: Baseline
Muscle mass : DXA
Muscle mass will be measured by DXA in kg
Measured: Baseline
Muscle mass : impedancemetry
Muscle mass will be measured by impedancemetry in kg
Measured: Baseline
Bone mineral density
Bone mineral density will be measured by DXA in g/cm²
Measured: Baseline
Resting energy metabolism
Resting energy metabolism will be measured by indirect calorimetry in Kcal/day
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start6 Nov 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The cohort will be a sub-group derived from the 425 healthy female volunteers who will be recruited for the MONIKA study. For the MONIKA study, we expect around 350 to be recruited at the Nîmes and Montpellier sites. Among these women recruited at the Nîmes and Montpellier sites, 280 participants will be invited to take part in the MyOs study.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibault MURA, Prof., Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683222
- Sponsor's protocol ID
- AO12022/2023/VB-01
- Acronym
- MyOs
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is managed by the BESPIM (Biostatistics, Clinical Epidemiology, Public Health and Methodological Innovation Department) at the Nîmes University Hospital. The conditions under which all or part of the research database may be transferred are decided by the research sponsor and are set out in a written contract.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06683222
- Acronym / sponsor ID
- MyOs / AO12022/2023/VB-01
- Conditions
- Bone Density
- Keywords
- Myokines
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bone densitometry using X-ray absorptiometry (DXA) is the reference technique for measuring Bone Mineral Density (BMD). According to the International Osteoporosis Foundation (IOF), if a single site is to be preferred, it should be the total hip or femoral neck, using a single NHANES III reference curve. It should be stressed, however, that this curve was obtained from a North American population with anthropometric parameters, notably body mass index (BMI), that differ from those of the European population, particularly the Caucasian population. Apparently, only one reference curve has been obtained in France, from the OFELY study in 1993. Given the age of this cohort and the possibility of BMI changes over time in the Caucasian population, but even more so, the impossibility of transposing this curve onto new DXAs of different brands, new reference curves need to be developed. DMS IMAGING is therefore financing the MONIKA study, with the CHU de Nîmes as sponsor.
As part of this study, some 425 healthy female volunteers aged between 20 and 89 will be recruited from three centers (Nîmes, Montpellier, Lyon). A DXA examination at various bone sites (femur, rachis, radius and whole body) will provide up-to-date normalcy curves for BMD, but also for body composition (fat and lean mass), which are currently lacking. Access to this population could also enable us to better understand bone physiology and the links that may exist between bone tissue and muscle and fat tissue.For example, the serum concentration of leptin, a hormone secreted by adipose tissue, is associated with bone mass in non-obese women.More recent data show that skeletal muscle also has a secretory activity, characterized by the production of myokines.In humans, there are various arguments in favour of myostatin's action on bone tissue.However, clinical studies in humans are very limited.Through two clinical studies, myokine levels were assessed in two populations with very different BMIs. Female patients suffering from anorexia nervosa, for example, showed decreased myostatin levels, increased follistatin levels and comparable irisin levels, in parallel with very low BMD, compared with a population of young, non-malignant women.
In obese women with high BMD, it was also shown that myostatin and follistatin levels were high, whereas irisin levels were lower than in a control population. Furthermore, the effect of lean body mass on BMD was partially mediated by irisin. These results are still preliminary, having been obtained on a small group of subjects, and merit further investigation on a representative population scale. However, there are apparently no age-dependent reference values for these myokines.
In addition to the involvement of these myokines in the muscle-bone complex, these factors could also be involved in the muscle-fat complex, since new functions are now being attributed to them, such as lipolysis, which could affect the concentrations of certain adipokines, such as leptin, which in turn could have an impact on bone formation and resorption. 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 BMIs (anorexic or obese patients) is significantly and independently associated with BMD.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The cohort will be a sub-group derived from the 425 healthy female volunteers who will be recruited for the MONIKA study. For the MONIKA study, we expect around 350 to be recruited at the Nîmes and Montpellier sites. Among these women recruited at the Nîmes and Montpellier sites, 280 participants will be invited to take part in the MyOs study.
| Arm | Type | Receives |
|---|---|---|
| Sub-group of 280 patients derived from the MONIKA study | Other | Diagnostic Test: Blood sample, Diagnostic Test: Saliva sample, Diagnostic Test: Grip test, Other: MicroFET2® maximum isometric force test, Other: Maximum isometric knee extension bench test., Other: The SPPB (Short Physical Performance Battery), Other: The 6-minute walking test., Other: Segmental impedancemetry examination., Other: Indirect calorimetry test., Other: Fardellone's questionnaire, Other: ONAPS questionnaire, Other: Dietary intake.questionnaire |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (45 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample36 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) | Diagnostic test | Sub-group of 280 patients derived from the MONIKA study |
| Saliva sample5 ml of saliva will be taken. | Diagnostic test | Sub-group of 280 patients derived from the MONIKA study |
| Grip testThe 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. | Diagnostic test | Sub-group of 280 patients derived from the MONIKA study |
| MicroFET2® maximum isometric force testThe 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 | Other | Sub-group of 280 patients derived from the MONIKA study |
| Maximum isometric knee extension bench test.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. | Other | Sub-group of 280 patients derived from the MONIKA study |
| The SPPB (Short Physical Performance Battery)Battery of tests comprising a balance test, a walking speed test and a chair-lift test | Other | Sub-group of 280 patients derived from the MONIKA study |
| The 6-minute walking test.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. | Other | Sub-group of 280 patients derived from the MONIKA study |
| Segmental impedancemetry examination.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. | Other | Sub-group of 280 patients derived from the MONIKA study |
| Indirect calorimetry test.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. | Other | Sub-group of 280 patients derived from the MONIKA study |
| Fardellone's questionnaireCompletion of a questionnaires on calcium intake (Fardellone) | Other | Sub-group of 280 patients derived from the MONIKA study |
| ONAPS questionnaireThe ONAPS questionnaire contains questions on physical activity and sedentariness | Other | Sub-group of 280 patients derived from the MONIKA study |
| Dietary intake.questionnaireThe 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. | Other | Sub-group of 280 patients derived from the MONIKA study |
Primary outcome
Myostatin
Time frame: Baseline
Plasma concentration of myostatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Follistatin
Time frame: Baseline
Plasma concentration of follistatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Irisin
Time frame: Baseline
Plasma concentration of irisin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay
Bone Mineral Density
Time frame: Baseline
Bone densitometry using X-ray absorptiometry (DXA) measured in g/cm²
Lean body mass
Time frame: Baseline
Impedencemetry, measured in Kg
18 secondary outcomes
Leptin
Time frame: Baseline
Adiponecotin
Time frame: Baseline
Fat mass
Time frame: Baseline
Bone mineral density: impedencemetry
Time frame: Baseline
Grip test
Time frame: Baseline
Isometric force
Time frame: Baseline
Walking test
Time frame: Baseline
Short Physical Performance Battery : Balance test
Time frame: Baseline
Short Physical Performance Battery : Walking speed test
Time frame: Baseline
Short Physical Performance Battery : Chair lift test
Time frame: Baseline
Plasma concentration of osteocalcin, a bone remodelling marker.
Time frame: Baseline
Plasma concentration of serum cross-linked C-telopeptide of type I collagen (CTX), a bone remodelling marker.
Time frame: Baseline
Calcium intake
Time frame: Baseline
Level of physical activity
Time frame: Baseline
Muscle mass : DXA
Time frame: Baseline
Muscle mass : impedancemetry
Time frame: Baseline
Bone mineral density
Time frame: Baseline
Resting energy metabolism
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No. The data is managed by the BESPIM (Biostatistics, Clinical Epidemiology, Public Health and Methodological Innovation Department) at the Nîmes University Hospital. The conditions under which all or part of the research database may be transferred are decided by the research sponsor and are set out in a written contract.
Related trials for Bone Density
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Recruiting
Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
Bone Mineral Density, Primary Implant Stability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thibault MURA, Prof. study director
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, Saliva sample and Grip test in people with Bone Density, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent BOUDOUSQ, Dr (+334.66.68.32.66, vincent.boudousq@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myostatin (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.