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Research on Key Techniques for Differentiation and Classification of Primary Osteoporosis Based on Microbial Metabolism and Evaluation of Therapeutic Effects

Research on Key Techniques for Differentiation and Classification of Primary Osteoporosis Based on Microbial Metabolism and Evaluation of Therapeutic Effects

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075890
Enrollment
Unknown
Registered
2023-09-19
Start date
2023-09-20
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Primary osteoporosis

Interventions

control:none
Osteoporosis 1:none
Osteoporosis 2:none

Sponsors

Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for cases of osteoporosis (1) Women aged 50-70 who have experienced natural menopause and have experienced menopause for more than 1 year. (2) The bone density examination indicates a decrease of more than 2.5 standard deviations in the mean bone density of the 2nd to 4th vertebrae of the lumbar spine, hip bone density, or femoral neck bone density at any one location. (3) Conforming to the diagnosis of kidney deficiency or spleen kidney deficiency in traditional Chinese medicine. (4) Volunteer to be the subject and sign an informed consent form. Inclusion criteria for healthy subjects (1) Healthy women aged 18-30. (2) The bone density is normal. (3) Eat regularly and have a normal routine. (4) Volunteer to be the subject and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for cases of osteoporosis (1) Patients with severe primary diseases such as cardiovascular, hematopoietic, and neuropsychiatric systems. (2) Patients who have received hormone replacement (HRT) or calcitonin treatment within the past 3 months, or have received bisphosphonate treatment for 15 consecutive days or more within the past 6 months. Exclusion criteria for healthy subjects (1) Take any medication or health products within the past 3 months. (2) Recently, there have been gastrointestinal symptoms.

Design outcomes

Primary

MeasureTime frame
Gut microbiota spectrum;metabolomics;

Secondary

MeasureTime frame
bone metabolism;sex hormone;

Countries

China

Contacts

Public ContactYongfang Zhao

Shanghai University of Traditional Chinese Medicine

zhao_dingding@126.com+86 135 0181 9578

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026