Bone Loss, Age-relatedMICROBONENCT04265742
Microbiota and Bone Fragility:Study of the Relation Between Gut Microbiota and Bone Microarchitecture
A study testing bone densitometry, High resolution peripheral QCT and Collection of biological samples in people with Bone Loss, Age-related, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Gut microbiota regulate metabolism of their human host. Some diseases are associated with variations in gut microbiota diversity and higher fracture risk. Intestinal bacteria synthesize or influence synthesis of factors modulating bone metabolism. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Bone Loss, Age-related
- What is being tested?
- bone densitometry, High resolution peripheral QCT and Collection of biological samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2019to 4 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-menopausal women
- with a normal Bone Mineral Density (T-score >-1.5) at the 3 sites (lumbar spine, total hip and femoral neck) or with osteoporosis (T-score ≤ -2.5) at least at one of the 3 sites.
Who cannot join
- Current antibiotherapy or in the last 6 months or repeated antibiotherapy
- Current corticotherapy or stopped for less than 6 months
- Current treatment of osteoporosis or having lasted more than 3 months in the last 5 years
- Current hormonal treatment for menopause
- Current or discontinued drugs that may affect bone metabolism (eg anti-aromatase)
- Known hepatic, cardiac or respiratory insufficiency
Show all 12Show fewer
- Pathologies that may affect bone metabolism, particularly severe renal insufficiency
- Serious illnesses, particularly disabling and chronic diseases of the gastrointestinal tract
- Diseases characterized by substantial disorders of the gut microbiota (eg severe obesity, BMI> 40 kg / m2, depression, poorly controlled diabetes)
- Psychiatric pathology hindering understanding
- Difficulty understanding oral French
- Person protected by law, unable to express her consent, subject to a protective measure or deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbiota and Bone Fragility: Study of the Relation Between Gut Microbiota and Bone Microarchitecture (Microbone)
Gut microbiota regulate metabolism of their human host. Some diseases are associated with variations in gut microbiota diversity and higher fracture risk. Intestinal bacteria synthesize or influence synthesis of factors modulating bone metabolism. The link between gut microbiota and bone was assessed mainly in experimental animal studies. Clinical data, e.g. on the role of gut microbiota in postmenopausal osteoporosis are scarce. The investigators will compare gut microbiota composition in four groups of women aged ≥60 recruited on the basis of bone mineral density (BMD) and personal history of fracture. the participants will have diagnostic exams: clinical tests, bone densitometry (body composition, vertebral fractures), high resolution peripheral QCT (bone strength estimated by microfinite element analysis, micro-FEA), biological sample collection. Gut microbiome profiling will be performed at the INRA MetaGenoPolis laboratory. The investigators will compare gut microbiota diversity according to BMD level and to the fracture status. The investigators will analyze interactions of the gut microbiota diversity with bone status (bone turnover rate, BMD, bone microarchitecture, bone strength estimated by micro-FEA), muscle mass and strength, inflammatory cytokines and micro-RNAs modulating their expression. This study will provide new data concerning the importance of gut microbiota for the fracture risk in older women. It will help to identify the main metabolic pathways underlying the observed associations.
Read the detailed description
Postmenopausal osteoporosis is a major public health problem in developed countries. Despite the progress, knowledge of its pathophysiological mechanisms and identification of women at high risk of fracture in the clinical practice are not satisfactory. Gut microbiota consist of trillions of commensal bacteria playing a major role in the regulation of metabolism of their human host. Some conditions (diabetes mellitus, obesity, liver cirrhosis, inflammatory bowel disease, end stage renal disease, depression, heavy drinking, heavy smoking) are associated with variations in gut microbiota diversity and higher risk of fracture. Intestinal bacteria synthesize or influence the synthesis of factors which modulate bone metabolism, e.g. lipopolysaccharide (present in the wall of Gram-negative bacteria), inflammatory cytokines (synthesized in the gut associated lymphoid tissue), serotonin (synthesized in the colon epithelium), short-chain fatty acids, estrogens (deconjugation of sulphates and glucuronides). Data on the association between gut microbiota and bone metabolism were obtained mainly in experimental animal studies. Clinical data are limited. Data on the possible role of gut microbiota in the pathophysiology of the postmenopausal osteoporosis are scarce.
The investigators will carry out a cross-sectional comparison of gut microbiota composition in four groups of women aged 60 and over recruited on the basis of their bone mineral density (BMD) and personal history of fragility fracture. The primary statistical analyses will be focused on the comparison of gut microbiota diversity according to BMD (in women with the same fracture status) and according to the fracture status (in women with similar BMD). The investigators will analyze interactions of the gut microbiota diversity, its metabolic activity and other metabolic factors on the one hand, with bone status on the other hand. The investigators will study the association of gut microbiota composition with bone turnover rate, BMD, bone microarchitecture, bone strength estimated by microfinite element analysis (micro-FEA) and with physical performance, muscle mass and strength. The investigators will assess the impact of microRNAs modulating the expression of inflammatory cytokines on the serum levels of these cytokines according to the pattern of gut microbiota diversity and their associations with the characteristics of bone status (e.g. bone microarchitecture). The investigators will analyze the association between serum serotonin, abundance of intestinal bacteria stimulating serotonin synthesis (some Clostridia species) in the colon and the characteristics of bone status.
This study will provide new data concerning the importance of gut microbiota for the fracture risk in older women. The main limitation of this study is its cross-sectional design but this is the first clinical study exploring this subject. It will help to identify the main metabolic pathways underlying the observed associations. These data will stimulate experimental studies to elucidate biological mechanisms underlying these associations. the results will provide indications for future clinical and experimental studies. In the long run, the results will lead up to future studies permitting to develop new biological markers of fracture risk in older women and new anti-osteoporotic medications.
- Conditions
- Bone Loss, Age-related
- Being tested
- bone densitometry, High resolution peripheral QCT, Collection of biological samples, questionnaires, clinical tests
- Keywords
- Bone microarchitecture, intestinal microbiote, post-menopausal women, bone remodeling
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone densitometryRadiation
Bone Mineral Density (BMD), body composition, vertebral fractures
High resolution peripheral QCTRadiation
High resolution peripheral QCT (HR-pQCT): bone microarchitecture and bone strength
Collection of biological samplesDiagnostic test
Peripheral blood and urine samples to assess bone turnover markers and cytokines; and faeces to assess gut microbiota composition
questionnairesOther
Epidemiologic and nutritional questionnaire and physical activity scale
clinical testsOther
physical performance tests and grip strenght measurement
| Study group | Role | What they receive |
|---|---|---|
| Group A. Normal BMD, no fracture | Experimental | Post-menopausal women with normal bone density (BMD t-score >-1.5) and no history of fractures. Intervention: bone densitometry, high resolution peripheral QCT(HR-pQCT), collection of biological samples, questionnaires, clinical tests. Receives: Radiation: bone densitometry; Radiation: High resolution peripheral QCT; Diagnostic Test: Collection of biological samples; Other: questionnaires; Other: clinical tests |
| Group B. Normal BMD, with fracture | Experimental | Post-menopausal women with normal bone density (BMD T-score >-1.5) with history of fractures. Intervention: bone densitometry, high resolution peripheral QCT(HR-pQCT), collection of biological samples, questionnaires, clinical tests. Receives: Radiation: bone densitometry; Radiation: High resolution peripheral QCT; Diagnostic Test: Collection of biological samples; Other: questionnaires; Other: clinical tests |
| Group C. osteoporotic, no fracture | Experimental | Post-menopausal women with low bone density (BMD T-score <-2.5) and no history of fractures. Intervention: bone densitometry, high resolution peripheral QCT(HR-pQCT), collection of biological samples, questionnaires, clinical tests. Receives: Radiation: bone densitometry; Radiation: High resolution peripheral QCT; Diagnostic Test: Collection of biological samples; Other: questionnaires; Other: clinical tests |
| Group D. osteoporotic, with fracture | Experimental | Post-menopausal women with low bone density (BMD T-score <-2.5) with history of fractures. Intervention: bone densitometry, high resolution peripheral QCT(HR-pQCT), collection of biological samples, questionnaires, clinical tests. Receives: Radiation: bone densitometry; Radiation: High resolution peripheral QCT; Diagnostic Test: Collection of biological samples; Other: questionnaires; Other: clinical tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the composition of the gut microbiota according to fracture status in postmenopausal women with comparable bone mineral density.
The composition of the intestinal microbiota will be evaluated by the ratio between the amount of proinflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia) in postmenopausal women with mineral density comparable bone according to their fracture status.
Measured: through study completion, an average of 3 years
Secondary outcomes (7)
Determine the relationship between the composition of the gut microbiota and bone microarchitecture according to fracture status in postmenopausal women with comparable bone mineral density.
Relationship between gut microbiota composition (evaluated by the ratio between the amount of proinflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia)) and bone microarchitecture of the distal radius and tibia measured by High resolution peripheral QCT in each of the 4 groups of women (Normal BMD with or without fracture, osteoporosis with or without fracture).
Measured: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and bone mineral density according to fracture status in postmenopausal women with comparable bone mineral density.
Relationship between gut microbiota composition (evaluated by the ratio between the amount of proinflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia)) and bone mineral density measured by DXA in each of the 4 groups of women (Normal BMD with or without fracture, osteoporosis with or without fracture).
Measured: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and muscle mass and strength according to fracture status in postmenopausal women with comparable bone mineral density.
Relationship between gut microbiota composition (evaluated by the ratio between the amount of proinflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia)) and muscle mass (assessed by whole body composition measured by DXA) and strength (assessed by dynamometry) in each of the 4 groups of women (Normal BMD with or without fracture, osteoporosis with or without fracture).
Measured: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and physical performance according to fracture status in postmenopausal women with comparable bone mineral density.
Relationship between gut microbiota composition (evaluated by the ratio between the amount of proinflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia)) and physical performance (assessed by gait speed and clinical tests) in each of the 4 groups of women (Normal BMD with or without fracture, osteoporosis with or without fracture).
Measured: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and bone remodeling according to fracture status in postmenopausal women with comparable bone mineral density.
Relationship between gut microbiota composition( evaluated by the ratio between the amount of proinflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia)) and bone remodeling (evaluated by biochemical bone remodeling markers) in each of the 4 groups of women (Normal BMD with or without fracture, osteoporosis with or without fracture).
Measured: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and regulatory hormones of bone metabolism according to fracture status in postmenopausal women with comparable bone mineral density.
Relationship between gut microbiota composition (evaluated by the ratio between the amount of proinflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili)) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia) and regulatory hormones of bone metabolism (measured by dosages) in each of the 4 groups of women (Normal BMD with or without fracture, osteoporosis with or without fracture).
Measured: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and genetic factors according to fracture status in postmenopausal women with comparable bone mineral density.
Relationship between gut microbiota composition (evaluated by the ratio between the amount of proinflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia)) and genetic regulation assessed by GWAS (genome-wide association study) and miRNA study in each of the 4 groups of women (Normal BMD with or without fracture, osteoporosis with or without fracture).
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start8 Feb 2019
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, Age-relatedStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The composition of the intestinal microbiota will be evaluated by the ratio between the amount of pro-inflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia) in postmenopausal women with comparable bone mineral density, according to their fracture status.
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Pawel SZULC, MD, Ph.D, Principal investigator, Hospital Edouard Herriot, , 69437 Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265742
- Sponsor's protocol ID
- C18-04
- Other IDs
- 2018-A01806-49
- Acronym
- MICROBONE
- Status last verified
- Aug 2021
- First submitted
- 24 Sep 2018
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota and Bone Fragility: Study of the Relation Between Gut Microbiota and Bone Microarchitecture (Microbone)
- ClinicalTrials.gov ID
- NCT04265742
- Acronym / sponsor ID
- MICROBONE / C18-04
- Conditions
- Bone Loss, Age-related
- Keywords
- Bone microarchitecture, intestinal microbiote, post-menopausal women, bone remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 12 Feb 2020 (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.
Gut microbiota regulate metabolism of their human host. Some diseases are associated with variations in gut microbiota diversity and higher fracture risk. Intestinal bacteria synthesize or influence synthesis of factors modulating bone metabolism. The link between gut microbiota and bone was assessed mainly in experimental animal studies. Clinical data, e.g. on the role of gut microbiota in postmenopausal osteoporosis are scarce. The investigators will compare gut microbiota composition in four groups of women aged ≥60 recruited on the basis of bone mineral density (BMD) and personal history of fracture. the participants will have diagnostic exams: clinical tests, bone densitometry (body composition, vertebral fractures), high resolution peripheral QCT (bone strength estimated by microfinite element analysis, micro-FEA), biological sample collection. Gut microbiome profiling will be performed at the INRA MetaGenoPolis laboratory. The investigators will compare gut microbiota diversity according to BMD level and to the fracture status. The investigators will analyze interactions of the gut microbiota diversity with bone status (bone turnover rate, BMD, bone microarchitecture, bone strength estimated by micro-FEA), muscle mass and strength, inflammatory cytokines and micro-RNAs modulating their expression. This study will provide new data concerning the importance of gut microbiota for the fracture risk in older women. It will help to identify the main metabolic pathways underlying the observed associations.
Detailed description
Postmenopausal osteoporosis is a major public health problem in developed countries. Despite the progress, knowledge of its pathophysiological mechanisms and identification of women at high risk of fracture in the clinical practice are not satisfactory. Gut microbiota consist of trillions of commensal bacteria playing a major role in the regulation of metabolism of their human host. Some conditions (diabetes mellitus, obesity, liver cirrhosis, inflammatory bowel disease, end stage renal disease, depression, heavy drinking, heavy smoking) are associated with variations in gut microbiota diversity and higher risk of fracture. Intestinal bacteria synthesize or influence the synthesis of factors which modulate bone metabolism, e.g. lipopolysaccharide (present in the wall of Gram-negative bacteria), inflammatory cytokines (synthesized in the gut associated lymphoid tissue), serotonin (synthesized in the colon epithelium), short-chain fatty acids, estrogens (deconjugation of sulphates and glucuronides). Data on the association between gut microbiota and bone metabolism were obtained mainly in experimental animal studies. Clinical data are limited. Data on the possible role of gut microbiota in the pathophysiology of the postmenopausal osteoporosis are scarce.
The investigators will carry out a cross-sectional comparison of gut microbiota composition in four groups of women aged 60 and over recruited on the basis of their bone mineral density (BMD) and personal history of fragility fracture. The primary statistical analyses will be focused on the comparison of gut microbiota diversity according to BMD (in women with the same fracture status) and according to the fracture status (in women with similar BMD). The investigators will analyze interactions of the gut microbiota diversity, its metabolic activity and other metabolic factors on the one hand, with bone status on the other hand. The investigators will study the association of gut microbiota composition with bone turnover rate, BMD, bone microarchitecture, bone strength estimated by microfinite element analysis (micro-FEA) and with physical performance, muscle mass and strength. The investigators will assess the impact of microRNAs modulating the expression of inflammatory cytokines on the serum levels of these cytokines according to the pattern of gut microbiota diversity and their associations with the characteristics of bone status (e.g. bone microarchitecture). The investigators will analyze the association between serum serotonin, abundance of intestinal bacteria stimulating serotonin synthesis (some Clostridia species) in the colon and the characteristics of bone status.
This study will provide new data concerning the importance of gut microbiota for the fracture risk in older women. The main limitation of this study is its cross-sectional design but this is the first clinical study exploring this subject. It will help to identify the main metabolic pathways underlying the observed associations. These data will stimulate experimental studies to elucidate biological mechanisms underlying these associations. the results will provide indications for future clinical and experimental studies. In the long run, the results will lead up to future studies permitting to develop new biological markers of fracture risk in older women and new anti-osteoporotic medications.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The composition of the intestinal microbiota will be evaluated by the ratio between the amount of pro-inflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia) in postmenopausal women with comparable bone mineral density, according to their fracture status.
| Arm | Type | Receives |
|---|---|---|
| Group A. Normal BMD, no fracture | Experimental | Radiation: bone densitometry, Radiation: High resolution peripheral QCT, Diagnostic Test: Collection of biological samples, Other: questionnaires, Other: clinical testsPost-menopausal women with normal bone density (BMD t-score >-1.5) and no history of fractures. Intervention: bone densitometry, high resolution peripheral QCT(HR-pQCT), collection of biological samples, questionnaires, clinical tests. |
| Group B. Normal BMD, with fracture | Experimental | Radiation: bone densitometry, Radiation: High resolution peripheral QCT, Diagnostic Test: Collection of biological samples, Other: questionnaires, Other: clinical testsPost-menopausal women with normal bone density (BMD T-score >-1.5) with history of fractures. Intervention: bone densitometry, high resolution peripheral QCT(HR-pQCT), collection of biological samples, questionnaires, clinical tests. |
| Group C. osteoporotic, no fracture | Experimental | Radiation: bone densitometry, Radiation: High resolution peripheral QCT, Diagnostic Test: Collection of biological samples, Other: questionnaires, Other: clinical testsPost-menopausal women with low bone density (BMD T-score <-2.5) and no history of fractures. Intervention: bone densitometry, high resolution peripheral QCT(HR-pQCT), collection of biological samples, questionnaires, clinical tests. |
| Group D. osteoporotic, with fracture | Experimental | Radiation: bone densitometry, Radiation: High resolution peripheral QCT, Diagnostic Test: Collection of biological samples, Other: questionnaires, Other: clinical testsPost-menopausal women with low bone density (BMD T-score <-2.5) with history of fractures. Intervention: bone densitometry, high resolution peripheral QCT(HR-pQCT), collection of biological samples, questionnaires, clinical tests. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- post-menopausal women
- with a normal Bone Mineral Density (T-score >-1.5) at the 3 sites (lumbar spine, total hip and femoral neck) or with osteoporosis (T-score ≤ -2.5) at least at one of the 3 sites.
Key exclusion criteria (12 listed)
- Current antibiotherapy or in the last 6 months or repeated antibiotherapy
- Current corticotherapy or stopped for less than 6 months
- Current treatment of osteoporosis or having lasted more than 3 months in the last 5 years
- Current hormonal treatment for menopause
- Current or discontinued drugs that may affect bone metabolism (eg anti-aromatase)
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 densitometryBone Mineral Density (BMD), body composition, vertebral fractures | Radiation | Group A. Normal BMD, no fracture, Group B. Normal BMD, with fracture, Group C. osteoporotic, no fracture, Group D. osteoporotic, with fracture |
| High resolution peripheral QCTHigh resolution peripheral QCT (HR-pQCT): bone microarchitecture and bone strength | Radiation | Group A. Normal BMD, no fracture, Group B. Normal BMD, with fracture, Group C. osteoporotic, no fracture, Group D. osteoporotic, with fracture |
| Collection of biological samplesPeripheral blood and urine samples to assess bone turnover markers and cytokines; and faeces to assess gut microbiota composition | Diagnostic test | Group A. Normal BMD, no fracture, Group B. Normal BMD, with fracture, Group C. osteoporotic, no fracture, Group D. osteoporotic, with fracture |
| questionnairesEpidemiologic and nutritional questionnaire and physical activity scale | Other | Group A. Normal BMD, no fracture, Group B. Normal BMD, with fracture, Group C. osteoporotic, no fracture, Group D. osteoporotic, with fracture |
| clinical testsphysical performance tests and grip strenght measurement | Other | Group A. Normal BMD, no fracture, Group B. Normal BMD, with fracture, Group C. osteoporotic, no fracture, Group D. osteoporotic, with fracture |
Primary outcome
Comparison of the composition of the gut microbiota according to fracture status in postmenopausal women with comparable bone mineral density.
Time frame: through study completion, an average of 3 years
The composition of the intestinal microbiota will be evaluated by the ratio between the amount of proinflammatory bacteria (Prevotellaceae, E. coli, Bacteroides vulgatus, Proteus mirabili) and the amount of anti-inflammatory bacteria (Faecalibacterium, Roseburia) in postmenopausal women with mineral density comparable bone according to their fracture status.
7 secondary outcomes
Determine the relationship between the composition of the gut microbiota and bone microarchitecture according to fracture status in postmenopausal women with comparable bone mineral density.
Time frame: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and bone mineral density according to fracture status in postmenopausal women with comparable bone mineral density.
Time frame: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and muscle mass and strength according to fracture status in postmenopausal women with comparable bone mineral density.
Time frame: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and physical performance according to fracture status in postmenopausal women with comparable bone mineral density.
Time frame: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and bone remodeling according to fracture status in postmenopausal women with comparable bone mineral density.
Time frame: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and regulatory hormones of bone metabolism according to fracture status in postmenopausal women with comparable bone mineral density.
Time frame: through study completion, an average of 3 years
Determine the relationship between the composition of the gut microbiota and genetic factors according to fracture status in postmenopausal women with comparable bone mineral density.
Time frame: through study completion, an average of 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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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. This study is not recruiting at the moment.
Pawel SZULC, MD, Ph.D principal investigator
Hospital Edouard Herriot, , 69437 Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone densitometry, High resolution peripheral QCT and Collection of biological samples in people with Bone Loss, Age-related, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the composition of the gut microbiota according to fracture status in postmenopausal women with comparable bone mineral density. (time frame: through study completion, an average of 3 years). 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 31 Aug 2022.