Osteoporosis
Conditions
Interventions
Sponsors
Wangjing Hospital of China Academy of Traditional Chinese Medicine Sciences
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: **Study One: Inclusion Criteria for Osteoporosis Group** (1) Meets the diagnostic criteria for primary osteoporosis, based on DXA measurements of axial bones (lumbar vertebrae 1-4, femoral neck, or total hip) or the distal one-third of the radius, with a T-score = -2.5; (2) Age between 45 years and 80 years (excluding 80 years), with no gender restrictions; (3) Signed the informed consent form, and the participant voluntarily joined the study. **Inclusion Criteria for Healthy Control Group** (1) DXA measurement results show a T-score = -1.0; (2) Age between 45 years and 80 years (excluding 80 years), with no gender restrictions; (3) Signed the informed consent form, and the participant voluntarily joined the study. **Study Two: Inclusion Criteria** Based on the criteria of Study One, additional diagnostic criteria for syndrome differentiation and specific exclusion criteria for microbiome studies are added: **Inclusion Criteria for OP Blood Stasis Syndrome Group** (1) Meets the diagnostic criteria for primary OP, based on DXA measurements of lumbar vertebrae 1-4, femoral neck, or total hip, with a T-score = -2.5; (2) Meets the diagnostic criteria for blood stasis syndrome as per the "International Guidelines for the Diagnosis of Blood Stasis Syndrome," i.e., satisfies 1 major criterion or 2 minor criteria; (3) Age between 45 years and 80 years (excluding 80 years), with no gender restrictions; (4) Voluntarily participates in this clinical study and has signed the informed consent form. **Inclusion Criteria for OP Non-Blood Stasis Syndrome Group** (1) Meets the above diagnostic criteria for OP but does not satisfy any diagnostic criteria for blood stasis syndrome, as determined by two licensed TCM physicians; (2) Age between 45 years and 80 years (excluding 80 years), with no gender restrictions; (3) Voluntarily participates in this clinical study and has signed the informed consent form. **Inclusion Criteria for Healthy Control Group** (1) DXA measurement results show a T-score = -1.0, and excludes any manifestations of blood stasis syndrome; (2) Age between 45 years and 80 years (excluding 80 years), with no gender restrictions; (3) Voluntarily participates in this clinical study and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: Study One: (1) Patients with secondary osteoporosis; (2) Patients with severe cardiovascular diseases, hepatic or renal diseases, malignant tumors, or other wasting diseases, as well as infectious diseases; (3) Patients with Alzheimer's disease, mental disorders, or depression, or those unable to complete the trial; (4) Patients with other endocrine system diseases, such as Cushing's syndrome, hyperthyroidism, or hypothyroidism; (5) Patients who have taken medications affecting bone metabolism within the past 3 months, including oral or intravenous corticosteroids, or oral estrogen or progestin replacement therapy; (6) Patients currently participating in other clinical trials. Study Two: (1) Patients with severe primary diseases; (2) Patients with secondary osteoporosis; (3) Patients who have taken medications affecting bone metabolism within the past 2 weeks; (4) Patients who have taken antibiotics within the past 2 weeks; (5) Patients with oral diseases such as oral ulcers, glossitis, or periodontitis; (6) Patients currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tongue Coating Image;Oral microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| 25-hydroxyvitamin D;Osteocalcin;P1NP;Parathyroid Hormone;Fasting Blood Glucose;glycated hemoglobin;C-peptide;Insulin;Cholesterol;Triglyceride;High-Density Lipoprotein;Low-Density Lipoprotein; | — |
Countries
China
Contacts
Public ContactLu Jiajin
Wangjing Hospital of China Academy of Traditional Chinese Medicine Sciences
Outcome results
None listed