Postmenopausal Osteoporotic Thoracolumbar Vertebral Compression Fractures
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 55 years; 2. Postmenopausal women, defined as spontaneous amenorrhea > 2 years or > 2 years since bilateral oophorectomy; 3. Lumbar spine or hip BMD: -4.0 < T score < -2.5; 4. Thoracic or lumbar (T5-L5) vertebral compression fracture, with clinical manifestations consistent with imaging findings (X-ray or CT) indicating the location of the lesion; 5. The current fracture is a new vertebral fracture, defined as a vertebral fracture that occurred within the past 3 months, with MRI showing bone marrow edema; 6. Have undergone PVP or PKP surgery; 7. Willing to participate in the study and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients with a history of thoracolumbar radiotherapy or thoracolumbar surgery; 2. Known allergy to the active ingredients or excipients of the study drugs; 3. Contraindications to MRI examination; 4. Patients treated with open surgery; 5. Diseases that may affect bone metabolism, such as osteomalacia or osteogenesis imperfecta, Paget's disease, Cushing's syndrome, hyperprolactinemia, hypopituitarism, acromegaly, multiple myeloma, thyroid and parathyroid diseases, etc.; 6. Severe malabsorption, including celiac disease, short bowel syndrome, Crohn's disease, or previous gastric bypass surgery leading to impaired absorption of calcium and vitamin D; 7. Intolerance to calcium supplements; 8. Secondary osteoporosis due to medications; 9. Vertebral compression fractures caused by traumatic injuries; 10. Fractures at other sites; 11. Bone tumors or bone infections; 12. Contraindications related to the use of anti-osteoporosis drugs, such as hypocalcemia [serum calcium or albumin-adjusted serum calcium concentration <8.5 mg/dL (<2.2 mmol/L)], renal insufficiency [<60 mL/min/1.73 m²], etc.; 13. Serum 25-hydroxyvitamin D (25-OHD) <20 ng/mL; 14. Received parathyroid hormone (PTH) analogs (teriparatide), denosumab, calcitonin, bisphosphonates, or romosozumab within 6 months before PVP or PKP surgery; 15. Used active vitamin D (such as alfacalcidol, calcitriol, or edeclacalcitol) treatment within 1 month before PVP or PKP surgery; 16. Patients planning to receive teriparatide, bisphosphonates, active vitamin D, or romosozumab for other anti-osteoporosis treatments; 17. Patients with dental or jaw diseases requiring oral surgery within 6 months or planned for 12 months after enrollment; 18. History of osteomyelitis or osteonecrosis of the jaw; 19. Currently participating in other clinical studies; 20. Other conditions deemed unsuitable for participation in this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of new vertebral compression fracture (NVCF) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of new vertebral compression fracture (NVCF) ;The incidence of adjacent vertebral fractures ;Change from baseline in the patient's bone mineral density (BMD);The levels of bone turnover markers and bone metabolism markers at 6 and 12 months after operation;VAS pain scores at 3 months, 6 months, and 12 months after operation;Oswestry disability Index (ODI) ; | — |
Countries
China
Contacts
Public ContactLiu Hongjian
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed