Bone DensityMONIKANCT06983587
Reference Curves for Bone Mineral Density and Body Composition in Women Aged 20-89
A study testing Bone densitometry scan in people with Bone Density, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
Up-to-date normalcy curves for bone mineral density and body composition (fat and lean mass), are currently lacking. DMS IMAGING is therefore financing the MONIKA study, with Nîmes University Hospital as sponsor. 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?
- Bone densitometry scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2025to 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
- Ethnic origin European, Middle Eastern, North African and whose 2 parents are from Europe, Middle East, North Africa only as there is a difference in BMD according to ethnicity
- Person affiliated to or benefiting from a social security scheme
- Free, informed consent signed by the participant and the investigator (on the day of inclusion and before any examination required by the research).
Who cannot join
- Patients presenting one of the following major risk factors:
- Fragility fracture defined as a spontaneous or low-kinetic fracture (≤ one fall from height)
- Hip fracture in a first-degree relative
- Early menopause (< age 40), Hysterectomy (complete < age 40), Primary amenorrhea (absence of menstruation before age 15), Current amenorrhea of more than 3 months without contraceptive if patient is under age 40
- Treatments : Prolonged corticosteroid therapy > 3 months or > 1 g (cumulative dose)
- Immobilization of more than 3 months, less than 12 months old
Show all 46Show fewer
- Patients presenting one of the following pathologies affecting bone, muscle or adipose tissue:
- Chronic 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
- Haemopathy, neoplasia
- Hepatic insufficiency or chronic hepatitis
- Endocrinopathy: dysthyroidism, hypogonadism, hypercorticism, untreated acromegaly.
- Anorexia nervosa
- Hyperparathyroidism (even if controlled)
- History of digestive surgery (bariatric, gastrectomy, digestive resection other than appendectomy, etc.)
- History of organ transplant
- Chronic infectious disease (HIV, etc.)
- Weight loss of more than 10 kg in the last 6 months
- Paresis, marked lameness or unloading of a limb or prolonged immobilisation of more than one month in the last 12 months
- All patients on any treatment 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 oestrogen receptor modulator (Clomifen, Tamoxifen, Toremifen, Raloxifen)
- Anabolic steroids.
- Strontium ranelate
- Carbamazepine
- Phenobarbital
- Immunosuppressants
- Antiepileptics
- All patients with one of the following anomalies in the measurement area:
- Major deformities of the wrist, hip or vertebrae
- Compression of the vertebral bodies, cementoplasty
- Prosthesis, implant (breast, buttock, etc.), foreign body
- Hip paraosteoarthropathy
- Injection of radiological contrast product, barium enema, nuclear medicine examination within 10 days
- Miscellaneous :
- Intensive sport (more than 10 h/week).
- Extreme BMI (BMI < 18, BMI > 35 kg/m²).
- Loss of autonomy
- Pregnant, parturient or breast-feeding woman
- Participation in an interventional study involving a drug or medical device or a category 1 RIPH in the 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
Hôpital E Herriot UMR_S 1033
Lyon, 69700
Roland CHAPURLAT, Pr., +33472117482, roland.chapurlat@inserm.fr
University Hospital
Montpellier, Hérault, 34295
Denis Mariano Goulart, Prof., +334 64 33 85 98, d-mariano_goulart@chu-montpellier.fr
Laurent Maïmoun
About this study
Official title: Study to Establish Reference Curves for Bone Mineral Density (BMD) and Body Composition (BC) in Women Aged 20-89 MONIKA
Up-to-date normalcy curves for bone mineral density and body composition (fat and lean mass), are currently lacking. DMS IMAGING is therefore financing the MONIKA study, with Nîmes University Hospital as sponsor.
Some 425 healthy female volunteers aged 20 to 89 will be recruited from three centers (Nîmes, Montpellier and Lyon). A bone density scan at various bone sites (femur, rachis, radius and whole body) will provide up-to-date normalcy curves for bone mineral density as well as body composition (fat and lean mass). These measurements should help to better understand bone physiology and the links that may exist between bone tissue and muscle and adipose tissue.
This is a prospective multicenter cross-sectional descriptive study of healthy female volunteers. The study population is made up of healthy female volunteers from Europe, the Middle East and North Africa aged between 20 and 89, stratified into 7 age groups.
Read the detailed description
Bone densitometry using dual-photon X-ray absorptiometry (DXA) is the standard technique for measuring bone mineral density. 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 European populations, and more particularly of European, Middle Eastern and North African origin.
So far, 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 changes in BMI over time in the population of European, Middle Eastern and North African origin, 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 Nîmes University Hospital 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 adipose tissue.
- Conditions
- Bone Density
- Being tested
- Bone densitometry scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone densitometry scanRadiation
Also called Dual-energy X-ray absorptiometry (DEXA or DXA)
Each study participant will undergo a bone density measurement scan. The equipment used in this study will be the STRATOS DR X-ray bone densitometer (APELEM, 9 Avenue du Canal Philippe Lamour, 30660 Gallargues-le-Montueux, France). This device is indicated for diagnosing osteoporosis, assessing the risk of fracture in weakened bone areas, monitoring bone density, monitoring body composition and diagnosing vertebral anomalies (vertebral compression, fractures).
In general, the time for a scan is less than 1 min for the spine, less than than 1 min for the femur, less than 1 min for the forearm and around 4 min for the whole body.
The total duration of the patient's participation in this research will be approximately 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Women aged 20-29 | Other | This group will be used to construct the T-score equation, and thus define the thresholds for osteopenia and osteoporosis. To ensure adequate precision for this T-score, 175 subjects will be included in this age group. With this number of subjects, the following accuracies for two of the sites of interest (hip and L1-L4) are expected:
For the hip, the expected bone mineral density value is 0.95 (SD=0.11) according to local data consistent with Arlot et al. Inclusion of 175 subjects would give a ½ width 95% confidence interval (IC95%) of the mean would be around 0.016, and the half width standard deviation of 0.012 For L1-L4, the expected bone mineral density value is 0.99 (SD=0.11) according to local data consistent with Arlot et al. The ½ width of the 95% confidence interval (IC95%) of the mean would be around 0.016, and the half-width standard deviation of 0.012. Receives: Radiation: Bone densitometry scan |
| Women aged 30-39 | Other | For the 30-39 age group, only 25 subjects will be included, given the constancy of bone mineral density in this age group compared with the 20-29 age group. In addition, the results of the analyses will take the form of a Z-score equation, estimated using a regression method (i.e. overall and not a z-score per age group). As there will be many subjects under 30 and over 40, this will ensure (by interpolation) an equivalent precision in these age brackets to that of the adjacent age categories. Receives: Radiation: Bone densitometry scan |
| Women aged 40-49 | Other | Group including 50 subjects. Receives: Radiation: Bone densitometry scan |
| Women aged 50-59 | Other | Group including 50 subjects. Receives: Radiation: Bone densitometry scan |
| Women aged 60-69 | Other | Group including 50 subjects. Receives: Radiation: Bone densitometry scan |
| Women aged 70-79 | Other | Group including 50 subjects. Receives: Radiation: Bone densitometry scan |
| Women aged 80-89 | Other | Only 25 subjects will be included in this age group for reasons of feasibility. Receives: Radiation: Bone densitometry scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density of the femoral neck: Left side
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Measured: Day 0, day of inclusion
Bone mineral density of the femoral neck: Right side
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Measured: Day 0, day of inclusion
Bone mineral density of the femoral neck: Lumbar spine (L1 - L4)
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Measured: Day 0, day of inclusion
Bone mineral density of the femoral neck: Forearm
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Measured: Day 0, day of inclusion
Bone mineral density of the femoral neck: Whole body
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Measured: Day 0, day of inclusion
Secondary outcomes (15)
Percentage body fat: left hip
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Measured: Day 0, day of inclusion
Body fat: left hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Percentage body fat: right hip
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Measured: Day 0, day of inclusion
Body fat: right hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Muscle mass: left hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Muscle mass: right hip
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Percentage body fat in the region of the lumbar spine (L1 - L4)
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Measured: Day 0, day of inclusion
Body fat in the region of the lumbar spine (L1 - L4)
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Muscle mass in the region of the lumbar spine (L1 - L4)
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Percentage body fat: forearm
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Measured: Day 0, day of inclusion
Body fat: forearm
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Muscle mass: forearm
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Percentage body fat: whole body
Measured automatically by the STRATOS DR X-ray bone densitometer in %
Measured: Day 0, day of inclusion
Body fat: whole body
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Muscle mass: whole body
Measured automatically by the STRATOS DR X-ray bone densitometer in kg
Measured: Day 0, day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Montpellier, Hôpital Edouard Herriot
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983587
- Sponsor's protocol ID
- IDIL/2023/VB-01
- Acronym
- MONIKA
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be managed by the BESPIM (Biostatistics, Epidemiology, Public Health \& Innovations in Methodology, Nîmes University Hospital). The conditions for the transfer of all or part of the research database are decided by the research sponsor and are the subject of a written contract.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Establish Reference Curves for Bone Mineral Density (BMD) and Body Composition (BC) in Women Aged 20-89 MONIKA
- ClinicalTrials.gov ID
- NCT06983587
- Acronym / sponsor ID
- MONIKA / IDIL/2023/VB-01
- Conditions
- Bone Density
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- University Hospital, Montpellier, Hôpital Edouard Herriot
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 21 May 2025 (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.
Up-to-date normalcy curves for bone mineral density and body composition (fat and lean mass), are currently lacking. DMS IMAGING is therefore financing the MONIKA study, with Nîmes University Hospital as sponsor.
Some 425 healthy female volunteers aged 20 to 89 will be recruited from three centers (Nîmes, Montpellier and Lyon). A bone density scan at various bone sites (femur, rachis, radius and whole body) will provide up-to-date normalcy curves for bone mineral density as well as body composition (fat and lean mass). These measurements should help to better understand bone physiology and the links that may exist between bone tissue and muscle and adipose tissue.
This is a prospective multicenter cross-sectional descriptive study of healthy female volunteers. The study population is made up of healthy female volunteers from Europe, the Middle East and North Africa aged between 20 and 89, stratified into 7 age groups.
Detailed description
Bone densitometry using dual-photon X-ray absorptiometry (DXA) is the standard technique for measuring bone mineral density. 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 European populations, and more particularly of European, Middle Eastern and North African origin.
So far, 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 changes in BMI over time in the population of European, Middle Eastern and North African origin, 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 Nîmes University Hospital 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 adipose tissue.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Women aged 20-29 | Other | Radiation: Bone densitometry scanThis group will be used to construct the T-score equation, and thus define the thresholds for osteopenia and osteoporosis. To ensure adequate precision for this T-score, 175 subjects will be included in this age group. With this number of subjects, the following accuracies for two of the sites of interest (hip and L1-L4) are expected: For the hip, the expected bone mineral density value is 0.95 (SD=0.11) according to local data consistent with Arlot et al. Inclusion of 175 subjects would give a ½ width 95% confidence interval (IC95%) of the mean would be around 0.016, and the half width standard deviation of 0.012 For L1-L4, the expected bone mineral density value is 0.99 (SD=0.11) according to local data consistent with Arlot et al. The ½ width of the 95% confidence interval (IC95%) of the mean would be around 0.016, and the half-width standard deviation of 0.012. |
| Women aged 30-39 | Other | Radiation: Bone densitometry scanFor the 30-39 age group, only 25 subjects will be included, given the constancy of bone mineral density in this age group compared with the 20-29 age group. In addition, the results of the analyses will take the form of a Z-score equation, estimated using a regression method (i.e. overall and not a z-score per age group). As there will be many subjects under 30 and over 40, this will ensure (by interpolation) an equivalent precision in these age brackets to that of the adjacent age categories. |
| Women aged 40-49 | Other | Radiation: Bone densitometry scanGroup including 50 subjects. |
| Women aged 50-59 | Other | Radiation: Bone densitometry scanGroup including 50 subjects. |
| Women aged 60-69 | Other | Radiation: Bone densitometry scanGroup including 50 subjects. |
| Women aged 70-79 | Other | Radiation: Bone densitometry scanGroup including 50 subjects. |
| Women aged 80-89 | Other | Radiation: Bone densitometry scanOnly 25 subjects will be included in this age group for reasons of feasibility. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ethnic origin European, Middle Eastern, North African and whose 2 parents are from Europe, Middle East, North Africa only as there is a difference in BMD according to ethnicity
- Person affiliated to or benefiting from a social security scheme
- Free, informed consent signed by the participant and the investigator (on the day of inclusion and before any examination required by the research).
Key exclusion criteria (46 listed)
- Patients presenting one of the following major risk factors:
- Fragility fracture defined as a spontaneous or low-kinetic fracture (≤ one fall from height)
- Hip fracture in a first-degree relative
- Early menopause (< age 40), Hysterectomy (complete < age 40), Primary amenorrhea (absence of menstruation before age 15), Current amenorrhea of more than 3 months without contraceptive if patient is under age 40
- Treatments : Prolonged corticosteroid therapy > 3 months or > 1 g (cumulative dose)
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 |
|---|---|---|
| Bone densitometry scanAlso: Dual-energy X-ray absorptiometry (DEXA or DXA)Each study participant will undergo a bone density measurement scan. The equipment used in this study will be the STRATOS DR X-ray bone densitometer (APELEM, 9 Avenue du Canal Philippe Lamour, 30660 Gallargues-le-Montueux, France). This device is indicated for diagnosing osteoporosis, assessing the risk of fracture in weakened bone areas, monitoring bone density, monitoring body composition and diagnosing vertebral anomalies (vertebral compression, fractures). In general, the time for a scan is less than 1 min for the spine, less than than 1 min for the femur, less than 1 min for the forearm and around 4 min for the whole body. The total duration of the patient's participation in this research will be approximately 2 hours. | Radiation | Women aged 20-29, Women aged 30-39, Women aged 40-49, Women aged 50-59, Women aged 60-69, Women aged 70-79, Women aged 80-89 |
Primary outcome
Bone mineral density of the femoral neck: Left side
Time frame: Day 0, day of inclusion
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Bone mineral density of the femoral neck: Right side
Time frame: Day 0, day of inclusion
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Bone mineral density of the femoral neck: Lumbar spine (L1 - L4)
Time frame: Day 0, day of inclusion
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Bone mineral density of the femoral neck: Forearm
Time frame: Day 0, day of inclusion
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
Bone mineral density of the femoral neck: Whole body
Time frame: Day 0, day of inclusion
Bone mineral density (BMD in g/cm2) for the construction of Z score and T score
15 secondary outcomes
Percentage body fat: left hip
Time frame: Day 0, day of inclusion
Body fat: left hip
Time frame: Day 0, day of inclusion
Percentage body fat: right hip
Time frame: Day 0, day of inclusion
Body fat: right hip
Time frame: Day 0, day of inclusion
Muscle mass: left hip
Time frame: Day 0, day of inclusion
Muscle mass: right hip
Time frame: Day 0, day of inclusion
Percentage body fat in the region of the lumbar spine (L1 - L4)
Time frame: Day 0, day of inclusion
Body fat in the region of the lumbar spine (L1 - L4)
Time frame: Day 0, day of inclusion
Muscle mass in the region of the lumbar spine (L1 - L4)
Time frame: Day 0, day of inclusion
Percentage body fat: forearm
Time frame: Day 0, day of inclusion
Body fat: forearm
Time frame: Day 0, day of inclusion
Muscle mass: forearm
Time frame: Day 0, day of inclusion
Percentage body fat: whole body
Time frame: Day 0, day of inclusion
Body fat: whole body
Time frame: Day 0, day of inclusion
Muscle mass: whole body
Time frame: Day 0, day of inclusion
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 21 May 2025.
- Individual participant dataSharing planned: No. All data will be managed by the BESPIM (Biostatistics, Epidemiology, Public Health \& Innovations in Methodology, Nîmes University Hospital). The conditions for the transfer of all or part of the research database are decided by the research sponsor and are the subject of a written contract.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone densitometry scan 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 46 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: opening soon, as of the sponsor's last update on 21 May 2025. 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?
Bone mineral density of the femoral neck: Left side (time frame: Day 0, day of inclusion). 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 21 May 2025.