osteoporotic vertebral compression fracture
Conditions
Interventions
Shangke Jiegu Tablets group:Conventional anti-osteoporosis treatment for 12 weeks followed by oral administration of Shangke Jiegu Tablets for 8 weeks.
Conventional Anti-Osteoporosis Treatment Group:Conventional anti-osteoporosis treatment for 12 weeks
Jiegu Qili Tablets group:Conventional anti-osteoporosis treatment for 12 weeks followed by oral administration of Jiegu Qili Tablets for 8 weeks.
In-house Formulation Group:Conventional anti-osteoporosis treatment for 12 weeks followed by oral administration of Guiqiong Yanggu Decoction for 8 weeks.
Sponsors
Shenzhen Pingle Orthopedics and Traumatology Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1 Meet the diagnostic criteria for osteoporotic vertebral compression fractures; 2 The time since the fracture occurred does not exceed 6 weeks; 3 Undergo PKP/PVP surgical treatment within 6 weeks after the fracture; 4 Postmenopausal women and men aged 50 years or older; 5 Willingly participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Fractures caused by bone tumors or fractures leading to nerve compression; 2. Limited mobility prior to the current fracture such as inability to walk normally due to post-stroke sequelae; 3. Abnormal laboratory tests within 24 hours after surgery with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) and serum creatinine >1.5×ULN; 4. Patients with uncontrolled arrhythmias unstable angina percutaneous coronary intervention coronary artery bypass grafting unstable angina or stroke within 3 months before screening; patients diagnosed with Class III or IV heart failure according to the New York Heart Association (NYHA) classification within the past 12 months; 5. Patients who have undergone gastrointestinal bypass surgery or have other severe intestinal absorption disorders; 6. History of mental illness or suspected or confirmed history of drug abuse; 7. Known allergies to the components of the study drug control drug or similar chemical structures; 8. Currently participating in other clinical trials or having participated in other clinical trials within the past 3 months; 9. Patients deemed by the investigator as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oswestry Disability Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| SF-12;The disappearance rate of pain caused by vertebral spinous process percussion injury;VAS score for lower back pain;Changes in Symptoms and Signs/Traditional Chinese Medicine Syndrome Score;Time of first spontaneous defecation after surgery; | — |
Countries
China
Contacts
Public ContactLin Wenping
Shenzhen Pingle Orthopedic Hospital (Shenzhen Pingshan Traditional Chinese Medicine Hospital)
Outcome results
None listed