primary osteoporosis
Conditions
Interventions
experimental group:Jin Tiange capsule, calcium carbonate simulation, a-D3
control group:Jin Tiange capsule simulation agent, the calcium carbonate, a-D3
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) female aged > 45 one full year of life, and more than one year, menopause menopause time is unknown to age > 60 years old; Men aged > 50 years of age; Men and women patients age to < 80 one full year of life; (2) the lumbar spine (BMD at l1-l4) or femoral Neck (Femur Neck) or Total Hip (Total Hip) bone mineral density test results show that T value 2.5 SD or less; T value < 1.0 SD, merging one or more risk factors (IOF questionnaire, see appendix 1) or OSTA score of 1 or less; (3) the patient of lumbar spine and proximal femur must be suitable for dual-energy X-ray absorptiometry measurement, not affect the measurement of severe scoliosis, bone trauma, lumbar spine, or hip implants, orthopaedic surgery complications, etc., and lumbar vertebral compression fractures in no more than 1 vertebral body; (4) 18.5 <= BMI< 28; (5) signed informed consent will be voluntarily.
Exclusion criteria
Exclusion criteria: (1) secondary osteoporosis (such as parathyroid function already, rheumatoid arthritis, multiple myeloma, etc.); Or suffering from bone tuberculosis, patients with malignant bone tumors; (2) diabetes blood sugar control falls below, fasting glucose > tendency for 11.1 / L, a1c > 8.0%, or accompanied by diabetes complications (diabetic nephropathy, peripheral neuropathy); (3) hyperphosphatemia (p > 1.62 serum tendency/L), hypercalcemia (serum calcium > 2.70 tendency/L), high urinary calcium disease (24 h urine calcium tendency > 7.5), AST, ALT, more than 1.5 times the normal limit; EGFR 90 MMHG) or have low blood pressure (resting seat) blood pressure < 90/50 MMHG; (5) in the past 3 months used drugs affect the metabolism of vitamin D, or nearly six months of estrogen and selective estrogen receptor modulators, calcitonin, fluoride, anabolic steroids, parathyroid hormone, etc. Or nearly 12 months used double phosphonic acid salts, etc., and other researchers think that may interfere with the evaluation of any drug or drug treatment methods; (6) has a history of myocardial infarction or stroke in the past six months, and suffer from severe cardiovascular disease including unstable angina, heart failure, or a history of life-threatening arrhythmias; (7) allergic constitution or always for a variety of drug allergy, or allergic to study the composition of drugs (such as vitamin D kind drug allergy history); (8) test before 3 months participated in other clinical research, and other researchers think that should not be involved in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMD; | — |
Secondary
| Measure | Time frame |
|---|---|
| P1NP;ß-CTX;scoring according symptoms and signs;numeric rating scale;Timed Up and Go Test;Chair Rising Test;Tandem Gait Test; | — |
Countries
China
Contacts
Public ContactXia Weibo
Peking Union Medical College Hospital
Outcome results
None listed