Postmenopausal Osteoporosis
Conditions
Interventions
Control Group:Do not perform any drug intervention.
Experimental Group: Bu Gu Sheng Sui Decoction(Oral)
Sponsors
Wangjing Hospital of China Academy of Chinese Medical Science
Eligibility
Sex/Gender
Female
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: Control group should meet the following inclusion criteria: (1) Meet the Western diagnostic criteria for normal bone mass, with T-score = -1.0 based on DXA measurements of axial bones (L1-4, femoral neck, or total hip) bone mineral density (BMD) or distal one-third of the radius BMD for the diagnosis of osteoporosis (OP); (2) Female, postmenopause > 2 years, and 45 years = age 2 years, and 45 years = age < 65 years; (3) Voluntarily participate in this clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Control Group Exclusion Criteria: (1) History of inflammatory diseases such as rheumatoid arthritis, osteoarthritis, etc.; (2) History of diabetes, thyroid diseases, and other endocrine diseases; (3) Severe dysfunction of major organs (heart, liver, kidneys), hematological disorders, acute or chronic infections, malignant tumors, or severe mental illnesses; (4) Long-term use of hormones such as glucocorticoids, sex hormones, active vitamin D, fluorides, antiepileptic drugs, etc.; (5) Any other conditions deemed unsuitable for participation in this study by the investigators. Treatment Group Exclusion Criteria: (1) Secondary osteoporosis (OP) or a history of fractures within the past year; (2) History of inflammatory diseases such as rheumatoid arthritis, osteoarthritis, etc.; (3) History of diabetes, thyroid diseases, and other endocrine diseases (including pituitary and hypothalamic-related diseases); (4) Use of zoledronic acid within the past year, use of denosumab within the past six months, or use of oral bisphosphonates, anti-osteoporosis Chinese herbal formulations, or antibiotics, with discontinuation less than three months prior; (5) Severe dysfunction of major organs (heart, liver, kidneys), hematological disorders, acute or chronic infections, malignant tumors, or severe mental illnesses; (6) Long-term use of hormones such as glucocorticoids, sex hormones, active vitamin D, fluorides, antiepileptic drugs, etc.; (7) Any other conditions deemed unsuitable for participation in this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone metabolism indicators (N-terminal propeptide of type I procollagen (P1NP), ß-C-terminal telopeptide of type I collagen (ß-CTX), etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Estradiol;Single-cell transcriptome sequencing;Bone Density;Inflammatory cytokines (IL-1, IL-6, IL-10, IL-17, IL-22, IL-35, TNF-a, etc.); | — |
Countries
China
Contacts
Public ContactZhu Ligu
Wangjing Hospital of China Academy of Chinese Medical Science
Outcome results
None listed