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Gut Microbiota-Metabolite Alterations Under Estrogen Deficiency and Intestinal Barrier Dysfunction in Osteoporosis

Ruminococcus-Mediated Butyrate Suppression by Estrogen Lack and Intestinal Barrier Impairment Induces Osteoporosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119730
Enrollment
Unknown
Registered
2026-03-03
Start date
2026-03-25
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic fracture

Interventions

Control group:None

Sponsors

First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 45-75 years old. 2. No use of drugs affecting bone metabolism within the past 1 year: such as bisphosphonates, calcitonin, parathyroid hormone, glucocorticoids (usage>3 months), selective estrogen receptor modulators (SERMs), etc. 3. Indications for orthopedic surgery: Surgical resection of bone (e.g., vertebral bodies, facet joints, proximal femur, distal radius, proximal humerus), muscle (e.g., paravertebral muscles, hip muscle groups), and ligament (e.g., supraspinous ligament, interspinous ligament, posterior longitudinal ligament, intervertebral discs, ligamentum flavum) is required. Surgical procedures include spinal fusion, kyphoplasty, open reduction and internal fixation (ORIF) for hip fractures, total hip arthroplasty, and open reduction and internal fixation (ORIF) for radial and humeral fractures. 4. The patient is conscious, voluntarily signs the informed consent form, and cooperates with the completion of clinical data collection and follow-up.

Exclusion criteria

Exclusion criteria: 1. Bone metabolic disorders other than primary osteoporosis: such as osteogenesis imperfecta, osteomalacia, multiple myeloma, bone metastatic carcinoma, etc. 2. Chronic diseases affecting estrogen metabolism or bone health: diabetes mellitus (glycated hemoglobin>7.5%), rheumatoid arthritis, systemic lupus erythematosus, chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD = stage 3), chronic liver disease, etc. 3. A history of major surgery, bone fracture, or strenuous exercise within the past 6 months (which may affect the state of the tissue transcription). 4. History of malignant tumors (within the past 5 years), psychiatric disorders, or cognitive dysfunction (impossibility of participating in the study). Alcohol dependence (daily consumption>25g) or smoking (daily>10 cigarettes, sustained for the past 10 years) (both affecting bone metabolism and gut microbiota).

Design outcomes

Primary

MeasureTime frame
gene sequencing;

Secondary

MeasureTime frame
Routine biochemical indicators;Bone density test;Pathological examination;

Countries

China

Contacts

Public ContactZheng Hongyu

First Affiliated Hospital of Kunming Medical University

642413278@qq.com+86 871 6532 4888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026