Postmenopausal Osteoporosis
Conditions
Interventions
Experimental group:Qianggu Capsule + basic treatment (Caltrate D + Celecoxib Capsules)
Control group:Qianggu Capsule placebo + basic treatment (Caltrate D + Celecoxib Capsules)
Sponsors
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Comorbid subjects who meet the diagnostic criteria for KOA (Kellgren-Lawrence grade II or III, unilateral), the diagnostic criteria for primary osteoporosis per the 2022 Guidelines, and the TCM syndrome criteria for Kidney Yang Deficiency. (2) PMOP duration = 1 year, and KOA duration = 3 months. (3) Postmenopausal female subjects with menopause = 1 year. (4) Bone pain Visual Analogue Scale (VAS) score = 3, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score = 20. (5) Age between 50 and 70 years (inclusive). (6) Subjects have not taken estrogen or any medications that affect bone metabolism (e.g., glucocorticoids, antiepileptic drugs, aluminum-containing antacids and proton pump inhibitors, chemotherapeutic agents, anticoagulants, thiazolidinediones, etc.) within the past month. (7) Voluntarily participate in this clinical study, sign the informed consent form, and the process of obtaining informed consent fully complies with ethical principles.
Exclusion criteria
Exclusion criteria: (1) Subjects with acute exacerbation of KOA synovitis. (2) Those who have taken traditional Chinese medicine (TCM) decoctions, Chinese patent medicines, or Western medicines for the treatment of osteoporosis or knee osteoarthritis within the past 1 week. (3) Subjects with known allergies to Qianggu Capsule, any of its ingredients, or the placebo components. (4) Subjects with allergy to sulfonamides. (5) Subjects with concurrent rheumatic arthritis, rheumatoid arthritis, gouty arthritis, suppurative arthritis, allergic arthritis, dermatopathic arthritis, knee joint tumors, tuberculosis, or other specific joint diseases. (6) Those who have undergone knee arthroplasty or other invasive knee procedures in the past. (7) Subjects with severe cardiovascular or cerebrovascular diseases, hematopoietic system disorders, malignant tumors, hepatic or renal insufficiency (with laboratory values exceeding 1.5 times the upper limit of normal), or psychiatric disorders. (8) Those who are currently participating in another clinical trial that may affect the evaluation of the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale for Bone Pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index;Kidney Yang Deficiency Syndrome Score;SF-12 Health Survey;Dual-energy X-ray absorptiometry;Knee X-ray examination;ß-CTX/P1NP;IL-1ß/TNF-a/IL-6;Comparison of rescue analgesic consumption between groups; | — |
Countries
China
Contacts
Public ContactCui Xin
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Outcome results
None listed