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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04265742
Other study ID # C18-04
Secondary ID 2018-A01806-49
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2019
Est. completion date February 4, 2022

Study information

Verified date August 2021
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
bone densitometry
Bone Mineral Density (BMD), body composition, vertebral fractures
High resolution peripheral QCT
High resolution peripheral QCT (HR-pQCT): bone microarchitecture and bone strength
Diagnostic Test:
Collection of biological samples
Peripheral blood and urine samples to assess bone turnover markers and cytokines; and faeces to assess gut microbiota composition
Other:
questionnaires
Epidemiologic and nutritional questionnaire and physical activity scale
clinical tests
physical performance tests and grip strenght measurement

Locations

Country Name City State
France Hopital E. Herriot Lyon

Sponsors (2)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France Merck Sharp & Dohme LLC

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. through study completion, an average of 3 years
Secondary 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). through study completion, an average of 3 years
Secondary 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). through study completion, an average of 3 years
Secondary 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). through study completion, an average of 3 years
Secondary 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). through study completion, an average of 3 years
Secondary 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). through study completion, an average of 3 years
Secondary 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). through study completion, an average of 3 years
Secondary 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). through study completion, an average of 3 years
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