Primary osteoporosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meeting the Western diagnostic criteria for primary osteoporosis; 2. Those who meet the TCM syndrome differentiation criteria of kidney deficiency and blood stasis; 3. Symptoms of low back pain, and the average weekly VAS score >= 3; 4. Both sexes. Male aged >= 70 years; Female aged >= 10 years after menopause (menopause is defined as women aged > 40 years who have not had menstruation 12 months after their last menstruation); 5. Sign the informed consent, be willing to accept examination, treatment and cooperate with the visitors.
Exclusion criteria
Exclusion criteria: 1. Secondary osteoporosis (such as osteomalacia, rheumatoid arthritis, gout multiple myeloma and other secondary osteoporosis); 2. OP patients with other TCM syndromes (such as spleen and stomach weakness, liver and kidney Yin deficiency syndrome); 3. Patients with current hyperthyroidism and hypothyroidism, hyperparathyroidism, tumor-induced osteolysis and osteocalcalcinosis; 4. Patients with congestive heart failure diagnosed as class III or IV according to the New York Heart Association (NYHA) classification within the past 12 months; Patients with uncontrolled arrhythmias and unstable coronary heart disease, percutaneous coronary intervention, unstable angina pectoris after coronary artery bypass grafting or stroke within 3 months before screening; 5. Patients with severe liver and renal insufficiency; 6. Previous or current malignant tumor; 7. Allergic constitution, allergic to calcium carbonate D3 tablets, Bushen Huoxue Decoction, Jiawei Yougui pill, Jintiange capsule; 8. Psychogenic low back pain or mental illness that researchers believe cannot be adequately controlled by medication; 9. Other drugs affecting bone metabolism were taken 2 weeks before enrollment, such as Xilinggubao capsule alendronate sodium tablets, teriparatide, raloxifene, calcitonin, etc., and zoledronic acid injection was used within one year before enrollment; 10. Participated in other clinical trials within 1 month; 11. Refuse treatment or fail to cooperate for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density;TCM syndrome integration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone transformation marker;Low back pain ODI score; | — |
Countries
China
Contacts
Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine