Osteopenia
Conditions
Interventions
Normal Bone Mass Cohort:None
Osteopenia Cohort:None
Osteoporosis Cohort:None
Osteopenia with Fragility Fractures Cohort:None
Sponsors
The First Hospital of Hunan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 50 to 80 years (inclusive of 50 years, exclusive of 80 years); male and female subjects are both eligible. 2. Voluntarily participate in this clinical study and sign the informed consent form. Subjects who meet only criteria 1 and 2 will be enrolled in different cohorts according to their T-scores and clinical diagnoses as follows: Those with a T-score >= -1.0 will be enrolled in the normal bone mass cohort; Those with a T-score between -1.0 and -2.5 (-1.0 > T-score > -2.5) will be enrolled in the osteopenia cohort; Those with a T-score T-score > -2.5) complicated with fragility fractures will be enrolled in the osteopenia with fragility fractures cohort.
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiovascular and cerebrovascular diseases, hepatorenal diseases, malignant tumors or other consumptive diseases, as well as patients with infectious diseases. 2. Patients with other endocrine system diseases, such as Cushing’s syndrome, hyperthyroidism, hypothyroidism, etc. 3. Subjects who have participated in other clinical trials within the past 3 months. 4. Patients with mental disorders such as Alzheimer’s disease, psychiatric diseases or depression, or those who are unable to cooperate with the completion of the trial. 5. Subjects who have taken drugs with a significant impact on bone metabolism within the past 3 months, such as glucocorticoids, high-dose thyroxine, parathyroid hormone, calcitonin, etc. 6. Subjects with poor treatment compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone mineral density (T-score);Bone marrow fat fraction (fat fraction, FF);Paraspinal muscle cross-sectional area;Vertebral bone quality (VBQ) score;Appendicular skeletal muscle mass (ASM);Skeletal muscle mass index (SMI);Visual Analog Scale (VAS) score;Lumbar Oswestry Disability Index (ODI) score;Bone turnover markers (P1NP, ß-CTX, osteocalcin, etc.);Lipid metabolism markers (TC, TG, HDL-C, LDL-C);Inflammatory markers (IL-6, IL-10);Sarcopenia-related markers (irisin, Myostatin, etc.);Traditional Chinese Medicine syndrome classification; | — |
Countries
China
Contacts
Public ContactYang Shaofeng
The First Hospital of Hunan University of Chinese Medicine
Outcome results
None listed