Microbiota and Bone Fragility:Study of the Relation Between Gut Microbiota and Bone Microarchitec… (NCT04265742) | Clinical Trial Compass
CompletedNot Applicable
Microbiota and Bone Fragility:Study of the Relation Between Gut Microbiota and Bone Microarchitecture
France440 participantsStarted 2019-02-08
Plain-language 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. 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.
Who can participate
Age range
60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of the composition of the gut microbiota according to fracture status in postmenopausal women with comparable bone mineral density.
Timeframe: through study completion, an average of 3 years
Trial details
NCT IDNCT04265742
SponsorInstitut National de la Santé Et de la Recherche Médicale, France