primary osteoporosis
Conditions
Interventions
Experimental group 1:Yigu recipe and Foundation treatment (Calcium and vitamin D and Kinesitherapy) and Selective estrogen receptor modulators (SERMs)
Control group 1:Foundation treatment (Calcium and vitamin D and Kinesitherapy) and Selective estrogen receptor modulators (SERMs)
Experimental group 2:Yigu recipe and Foundation treatment (Calcium and vitamin D and Kinesitherapy) and Bisphosphonates
Control group 2:Foundation treatment (Calcium and vitamin D and Kinesitherapy) and Bisphosphonates
Sponsors
The Third Hospital Affiliated to Zhejiang University of TCM
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: For postmenopausal osteoporosis: 1. According to the criterion of postmenopausal osteoporosis; including mild, moderate, and severe osteoporosis patients; 2. Women older than 50 years with postmenopausal more than 2 years and below 10 years; 3. volunteerly join the clinical trials researchers. For osteoporosis in senile: 1. According to the senile osteoporosis diagnostic criteria, including light, medium and severe osteoporosis patients; 2. Older than 70 years, women generally in postmenopausal 20 years, the type of bone loss for trabecular bone and cortical bone is age-related (not sex hormone dependent) of bone loss; 3. Senile patients with osteoporosis appear non-traumatic fractures; 4. volunteerly signed informed consent form.
Exclusion criteria
Exclusion criteria: For osteoporosis in postmenopausal women: 1. Disconform to the criterion of postmenopausal osteoporosis; 2. the aged 50 years old the following person; Aged 50 years of age or older, but menopause in 2 years the following or 10 years of female patients; 3. Secondary osteoporosis. If hyperparathyroidism, osteomalacia, rheumatoid arthritis, gout, multiple myeloma and secondary osteoporosis person; Or severe deformity, disability, loss of labor person; 4. Primary disease conbined with cardiovascular and cerebrovascular, liver, kidney and serious hematopoietic system; 5. Psychosis or dementia patients, cannot provide accurate patient's condition or cannot fit; 6. Chinese medicine was used to treated with osteoporosis person before a month; 7. Hormone replacement therapy (HRT)was used before three months and use of calcitonin (such as Miacalcic and Elcatonin ), osteoporosis drugs that Bisphosphonate had been used in the consecutive days during six months; 8. Merger fresh fractures and serious multiple fracture; 9. Spinal tuberculosis, tumour; 10. patients and their family members were unwilling to participate in the study. For osteoporosis in senile: 1. The secondary osteoporosis. If hyperparathyroidism, osteomalacia, rheumatoid arthritis, gout, multiple myeloma and secondary osteoporosis person; Or severe deformity, disability, loss of labor person; 2. Merge serious heart disease, heart, liver, kidney failure, and the psychiatric patients; 3. Not according to stipulations of drug use, can't judge curative effect or incomplete information affect curative effect and safety of the drug; 4. patients and their family members were unwilling to participate in the study; 5. The patients of osteopenia lead to fracture, postmenopausal women menopause within 20 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptom curative effect evaluation;Bone density;VAS pain score;scores on SF-36 scale;Fracture risk scale assessment;Serum alkaline phosphatase;Plasma anti tartaric acid acid phosphatase;Estradiol; | — |
Countries
China
Contacts
Public ContactYao Xinmiao
Outcome results
None listed