Observational study of herbal medicine treatment for osteoporosis and osteopenia patients
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0008028
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
1. Adults between 40 and 80 year old
2. Those diagnosed with osteopenia or osteoporosis with a T-score of less than -1 on the bone density test using DXA
3. Person who voluntarily signed the consent form after being fully explained about this human application test
1. If you are taking standard treatment for osteoporosis (Osteoporosis treatment such as bisphosphonate, parathyroid hormone, RANKL inhibitor)
2. A person suffering from the following diseases that can affect bone metabolism
- Endocrine and metabolic diseases (thyroid, hyperparathyroidism, uncontrolled diabetes, Cushing's syndrome, hyperprolactinemia, hypogonadism, hypopituitarism, etc.)
- Respiratory diseases (chronic obstructive pulmonary disease, asthma)
- Chronic renal failure
- rheumatic disease
- Digestive diseases (absorption disorders, gastrectomy, inflammatory bowel disease, chronic liver disease)
- Bone marrow disease (multiple myeloma, lymphoma, leukemia, hemolytic anemia)
- Malignant tumors (blood cancer, breast cancer, digestive system cancer)
- Taking immunosuppressive drugs after organ transplant
3. A person whose hypertension and hyperglycemia are not controlled despite taking treatment
4. Those who are taking glucocorticoid drugs that cause secondary osteoporosis or other drugs that can affect bone metabolism (PPI, SSRI, TZD, other types of anticonvulsants, etc.)
5. Those who have difficulty in visiting the hospital for research due to problems with walking and movement due to other musculoskeletal disorders
6. Those who have a disease that can affect drug absorption or have digestive problems after surgery related to it
7. Severe liver or kidney disease (at the time of screening, AST, ALT, ?-GTP, and serum creatinine are more than twice the upper limit of normal)
8. Pregnant, lactating or planning to become pregnant
9. Patients who participated in other clinical trials within 3 months
10. If the researcher determines that participation in a clinical study is inappropriate due to other reasons (hypercalcemia of 10.5 mg/dl or more, patients with underlying diseases accompanied by abnormal lipid metabolism, patients with serious underlying diseases, etc.)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BMD (T-score) measured by DXA: the initial value of BMD in the study and the change in BMD after 24 weeks of taking herbal medicine (Baseline, 24 weeks)
- Secondary Outcome Measures
Name Time Method Bone metabolism index(CTX, Ntx(urine), P1NP, OC, BSALP, Ca, P, Vit D, E2, IL-6, IGF-1, Cortisol);Deficiency Syndrome of Kidney Index;EQ-5d(EuroQol 5 Dimensions);consumption of medication;adverse event