Primary Osteoporosis
Conditions
Interventions
control group:Calcium Carbonate Tablets+Calcitriol Soft Capsule
test group:Gushukang Capsule+Calcium Carbonate Tablets+Calcitriol Soft Capsule
Sponsors
Wangjing Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for primary OP, and the diagnostic criteria for OP is T- value=-2.5; (2) Female menopause > 2 years and 45 years old = age < 80 years old, or 50 years old = male < 80 years old; (3) Voluntarily participate in this clinical study and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Lumbar fusion or severe degeneration hinders normal bone mineral density measurement, and there are less than 2 continuous intact lumbar vertebrae that can be evaluated by DXA measurement; (2) Patients with serious primary diseases such as cerebrovascular, digestive tract, and lung diseases (diseases whose clinical manifestations may interfere with the results of this study); (3) Secondary osteoporosis: including diabetes, thyroid disease, metabolic diseases such as Cushing's syndrome, rheumatoid arthritis, multiple myeloma, gout, malabsorption syndrome, systemic lupus erythematosus and other systemic diseases; (4) Use of drugs that affect bone metabolism, such as bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin, anti-osteoporosis Chinese medicine preparations such as Hugu Capsules, Jintiange capsules and other drugs; (5) Those with a history of severe mental illness or poor compliance; (6) Allergic constitution, and allergy to calcium or vitamin D; (7) Those who have participated in other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical indicators of bone metabolism [25(OH)D, osteocalcin (BGP), type I procollagen N-terminal propeptide (P1NP), ß-gluerin degradation product (ß-CTX)];Pain;TCM Syndrome Score;Balance ability;Lower extremity muscle strength;New fractures;Security indicators; | — |
Countries
China
Contacts
Public ContactXu Wei
Wangjing Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed