Osteoporosis (of the liver-kidney deficiency type)
Conditions
Interventions
Sponsors
Wangjing Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: Age =50 years, with no gender restriction ; 2. Meet the Western medical diagnostic criteria for osteoporosis as outlined in the "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2022)": DXA-measured axial bone mineral density or T-value of the distal one-third radius bone mineral density = -2.5; meet the TCM syndrome differentiation criteria for liver-kidney deficiency pattern ; participants must understand and comply with the study protocol, provide full informed consent voluntarily, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Patients who have used anti-osteoporosis medications such as bisphosphonates or teriparatide/desmopressin within the preceding 6 months; those on long-term glucocorticoid therapy (prednisone =5 mg/day for>3 months); individuals currently using anticoagulants (warfarin, rivaroxaban, etc.) ; patients with spinal deformities or those who have undergone lumbar or hip surgery and are unable to undergo DXA testing; those with uncontrolled hyperthyroidism (TSH 2 times the upper limit of normal); those with uncontrolled diabetes (HbA1c>9%) ; patients with severe cardiovascular or cerebrovascular diseases, chronic liver disease (ALT or AST =1.5 times the upper limit of normal reference values), or renal disease (serum creatinine>the upper limit of normal reference values) ; patients with known immunodeficiencies such as untreated or active malignancies, organ or bone marrow transplantation, or those taking immunosuppressants within the past 3 months ; pregnant women, women with suspected pregnancy, those planning pregnancy (within 3 months after study completion), or breastfeeding women ; individuals with allergic predisposition or known hypersensitivity to study medications ; patients who participated in other clinical trials within the preceding 3 months; those with mental disorders or cognitive impairments that would prevent cooperation with the study; or patients deemed by investigators to be intolerant to study medications or with any other contraindications to participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom Grading and Quantitative Standard Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Grading and Quantitative Standard Score;Bone mineral density (BMD) of the axial skeleton (L1~L4, femoral neck or total hip) or the distal one-third of the radius;TCM Syndrome (Individual Item, Total Score);TCM Syndrome (Individual Item, Total Score); | — |
Countries
China
Contacts
Public ContactHongmei Zhang
Wangjing Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed