osteoporotic vertebral compression fracture
Conditions
Interventions
Placebo Group:Shangke Jiegu Tablet Placebo: 4 tablets orally three times daily for 8 weeks
Jiegu Qili Tablet Placebo: 5 tablets orally twice daily for 8 weeks
Calcium Carbonate D3 (600 mg calcium + 125 IU vitamin D3 per tablet): 1 tablet orally once daily for 12 weeks
Calcitriol Soft Capsules (0.25 µg/capsule): 1 capsule orally twice daily for 12 weeks
Alendronate Sodium (70 mg/tablet): 1 tablet orally once weekly for 12 weeks.
Trial Group:Shangke Jiegu Tablet: 4 tablets orally three times daily for 8 weeks
Control Group:Shangke Jiegu Tablet Placebo: 4 tablets orally three times daily for 8 weeks
Jiegu Qili Tablet: 5 tablets orally twice daily for 8 weeks
Sponsors
The Third Affiliated Hospital of Beijing University of Chinese Medicine Beijing China
Eligibility
Sex/Gender
All
Age
50 Years to 95 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for osteoporotic vertebral compression fractures; 2. Patients who meet the preoperative criteria for osteoporotic fracture with qi stagnation and blood stasis syndrome with =2 of the 6 symptoms: Pain at the site of injury; Severe stabbing pain; Refusal to press on the painful area; Skin ecchymosis; Dark red tongue quality; Blood stasis obstruction of sublingual collaterals; 3. Single-segment fracture occurred within 14 days; 4 . Undergo unilateral transpedicular PKP/PVP surgical procedure within 14 days following the fracture; 5. Post-menopausal women and men over 50 years old; 6. Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Fractures caused by bone tumors and fractures leading to nerve compression; 2. Limited mobility prior to this fracture such as being unable to walk normally on the ground due to stroke sequelae; 3. Abnormal laboratory tests within 24 hours after surgery with ALT and AST > 2 times the upper limit of normal (ULN) and serum creatinine > 1.5 × ULN; 4. Intraoperative occurrence of bone cement leakage leading to serious complications; 5. Those who had uncontrolled arrhythmias unstable coronary heart disease after treatment percutaneous coronary intervention coronary artery bypass grafting unstable angina or stroke within 3 months before screening; those who were diagnosed with congestive heart failure at NYHA class III or IV within the past 12 months; 6. Those who have undergone gastrointestinal bypass surgery or have other severe intestinal absorption disorders; 7. Those with a history of mental illness or suspected or confirmed history of drug abuse; 8. Those with a known allergy to the components of the study drug control drug or placebo or substances with a similar chemical structure; 9. Those who are currently participating in other clinical trials or have participated in other clinical trials within the past 3 months; 10. Those whom the investigator deems unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Oswestry Disability Index (MODI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Turnover Markers;Time to First Postoperative Spontaneous Defecation (Days);Symptoms and Signs/TCM Syndrome Score;Hip Bone Mineral Density (BMD);Postoperative Vertebral Bone Quality (VBQ) Score in Injured Vertebra;Quality of Life (SF-12) Score;Disappearance Rate of Spinous Process Percussion Pain in Injured Vertebra;Modified Oswestry Disability Index (MODI);Bone Marrow Edema Score in Injured Vertebra;Incidence of Vertebral Re-fracture;Low Back Pain VAS Score; | — |
Countries
China
Contacts
Public ContactWeiheng Chen
The Third Affiliated Hospital of Beijing University of Chinese Medicine Beijing China
Outcome results
None listed