Osteoporotic fracture (liver and kidney deficiency syndrome)
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: 1. Age =50 years, with no gender restriction [1]; 2. Meet the Western medical diagnostic criteria for osteoporotic fractures as outlined in the "China Guidelines for Diagnosis and Treatment of Osteoporotic Fractures" [10]; The fracture site should be a fresh spinal compression fracture that is amenable to non-surgical treatment, with a Genant classification of mild severity [3]; Meet the TCM syndrome differentiation criteria for liver-kidney deficiency pattern [11]; 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.) [12]; 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%) [13]; 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) [13]; patients with known immunodeficiencies such as untreated or active malignancies, organ or bone marrow transplantation, or those taking immunosuppressants within the past 3 months [13]; pregnant women, women with suspected pregnancy, those planning pregnancy (within 3 months after study completion), or breastfeeding women [13]; individuals with allergic predisposition or known hypersensitivity to study medications [13]; 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 |
|---|---|
| VAS score of pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change (%) from baseline in bone mineral density (BMD) of the axial skeleton (L1–L4, femoral neck or total hip) or distal one-third of the radius;Change from baseline in Oswestry Disability Index (ODI) score;Onset time of pain relief;Time to complete pain relief;Proportions of onset of pain relief and complete pain relief at each visit time point;Change from baseline in TCM syndrome scores (individual items and total score); | — |
Countries
China
Contacts
Public ContactHongmei Zhang
Wangjing Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed