Primary osteoporosis Musculoskeletal Diseases Osteoporosis, unspecified
Conditions
Interventions
Patients who meet the inclusion and exclusion criteria will be randomly divided into the control group and the treatment group, with 80 patients in each group. The researchers will entrust a professio
Sponsors
China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Primary osteoporosis: T-value of bone density measurement is less than or equal to -2.5 2. Female aged from 45 to 70 years old and female menopause time is greater than 2 years, which are met at the same time. Male aged from 50 to 70 years old 3. Visual analogue scale (VAS) is greater than or equal to 3 points 4. Willing to participate in the study
Exclusion criteria
Exclusion criteria: 1. Lumbar fusion or severe degeneration hinders normal bone mineral density measurement and there are less than two continuous intact lumbar vertebrae that can be evaluated by dual-energy X-ray absorptiometry (DXA) 2. Patients with serious primary diseases such as cerebrovascular, digestive tract, and lung diseases, because these diseases’ clinical manifestations may interfere with the results of this study 3. Secondary osteoporosis, including rheumatoid arthritis, multiple myeloma, gout, malabsorption syndrome, systemic lupus erythematosus and metabolic diseases, such as diabetes, thyroid disease, Cushing's syndrome and other diseases 4. The patients take drugs that affect bone metabolism within 3 months before enrollment, such as bisphosphonates, glucocorticoids, calcitonin, anticonvulsant drugs, heparin and other drugs 5. Those with a history of severe mental illness or poor compliance 6. Allergic constitution 7. Those who have participated in other clinical trials within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Lower back pain is measured using the visual analogue scale (VAS, 0-10 points) at baseline, after the 6th month of enrollment, and the 6th month of follow-up after the end of treatment. 2. Balance ability is measured using the Berg balance scale (BBS, 0-56 points) at baseline, after the 6th month of enrollment, and the 6th month of follow-up after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bone mineral density (BMD) is measured using dual-energy X-ray absorptiometry (DXA) at baseline, after the 6th month of enrollment, and the 6th month of follow-up after the end of treatment 2. Laboratory tests (blood) using Luminex Assay at baseline, after the 6th month of enrollment, and the 6th month of follow-up after the end of treatment. The serological indicators include Type I Procollagen N-terminal Propeptide (P1NP), ß-collagen Degradation Product (ß-CTX), Myostatin (MSTN), Fibroblast Growth Factor-23 (FGF-23), Neuropeptide Y (NPY). 3. Fall risk is measured using the timed “up and go” test (TUGT) and morse fall scale (MFS, 0-125 points) at baseline, after the 6th month of enrollment, and 6th month of follow-up after the end of treatment 4. Lower extremity muscle strength is measured using five-times sit-to-stand test (FTSST) at baseline, after the 6th month of enrollment, and the 6th month of follow-up after the end of treatment | — |
Countries
China
Contacts
Public ContactXu Wei
Outcome results
None listed