postmenopausal osteoporosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The group of healthy volunteers should meet the following inclusion criteria: ? Meet the Western medical diagnostic criteria for normal bone mass, and the diagnostic criteria for OP based on the bone density of axial bone (lumbar spine 1-4, femoral neck or total hip) measured by DXA or distal radius 1/3 bone density for OP are T-value=-1.0; ? Women who have menopause > 2 years and 45 years old= age 2 years and are 45 years old= age < 65 years old; ? Visual anologue scale (VAS) to evaluate pain = 4 points; ? Voluntarily participate in this clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria for healthy volunteer groups: ? Lumbar fusion or severe degeneration interferes with normal bone densitometry, and fewer than two consecutive intact lumbar vertebrae are available for DXA measurement; ? People with serious primary diseases such as malignant tumors, cardiovascular, cerebrovascular, liver diseases, kidney diseases and hematopoietic system; ? Secondary osteoporosis: including diabetes, thyroid disease, Cushing's syndrome and other metabolic diseases, rheumatoid arthritis, multiple myeloma, gout, absorption disorder syndrome, systemic lupus erythematosus and other systemic diseases; ? Use of drugs that affect bone metabolism, such as glucocorticoids, calcitonin, anticonvulsants, heparin and other drugs, within 3 months before signing the informed consent form; ? History of serious mental illness or poor compliance; ? Those who participate in other clinical trials within 3 months; ? The investigator believes that other people are not suitable to participate in this research. PMOP Group Exclusion Criteria: ? Those who have developed osteoporotic fractures; ? Lumbar fusion or severe degeneration interferes with normal bone densitometry, and fewer than two consecutive intact lumbar vertebrae are available for DXA measurement; ? Serious primary diseases such as malignant tumors, cardiovascular, cerebrovascular, liver diseases, kidney diseases and hematopoietic system; ? Secondary osteoporosis: including diabetes, thyroid disease, Cushing's syndrome and other metabolic diseases, rheumatoid arthritis, multiple myeloma, gout, malabsorption syndrome, systemic lupus erythematosus and other systemic diseases; ? Use of drugs that affect bone metabolism, such as bisphosphonates, glucocorticoids, calcitonin, anticonvulsants, heparin and other drugs, within 3 months before signing the informed consent form; ? History of serious mental illness or poor compliance; ? Allergic constitution, and allergy to the known ingredients of this drug; ? Those who participate in other clinical trials within 3 months. ? The investigator believes that other people are not suitable to participate in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMD; | — |
Secondary
| Measure | Time frame |
|---|---|
| TC;ALP;ß-CTX;HDL;LDL;OC;P1NP;S1P;PI3K;AKT;GSK-3ß;Wnt;ß-catenin;LRP5;PPAR-?;Runx2;IL-6;Leptin;RhoA; | — |
Countries
China
Contacts
Wangjing Hospital, China Academy of Chinese Medical Sciences