Microbiota and Bone Fragility:Study of the Relation Between Gut Microbiota and Bone Microarchitecture

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.

Conditions

• Bone Loss, Age-related

Interventions

RADIATION

bone densitometry

Bone Mineral Density (BMD), body composition, vertebral fractures

RADIATION

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

OTHER

clinical tests

physical performance tests and grip strenght measurement

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Institut National de la Santé Et de la Recherche Médicale, France

  lead OTHER_GOV

Principal Investigators

• Pawel SZULC, MD, Ph.D · Hospital Edouard Herriot, , 69437 Lyon

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-08

Primary Completion

2022-02-04

Completion

2022-02-04

Countries

• France

Study Locations