spondylolisthesis or lumbar instability patients with primary osteoporosis
Conditions
Interventions
A:Denosumab 60 mg subcutaneously every 6 months
Supplement with calcium and vitamin D
B:Teriparatide 20 ug subcutaneously daily the 1st day after surgery to 12 months after surgery
C:Teriparatide 20 ug subcutaneously daily the 1st day after surgery to 12 months after surgery
Supplement with calcium and vitamin D
Denosumab 60 mg subcutaneously every 6 months with Teriparatide 20 ug subcutaneously daily the 1st day after surgery to 12 months after surgery
D:Calcium 600 mg/day and vitamin D 2000 IU/day
Sponsors
Dujiangyan People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.The patient, aged 40 to 90 years, was clinically diagnosed with spondylolisthesis or lumbar instability. 2.Patients with primary osteoporosis. 3.The patients and their family members gave informed consent and signed the informed consent form, with good compliance and willingness to cooperate with follow-up visits. 4. The patient undergo single-segment posterior lumbar interbody fusion
Exclusion criteria
Exclusion criteria: 1. Patients with allergies or contraindications to the study drug; 2. Patients who have undergone spinal surgery in the past; 3. Patients who have previously received treatment with zoledronic acid or other bisphosphonates; 4. Medications that may affect bone metabolism and renal function, such as parathyroid hormone, calcitonin, glucocorticoids, estrogen, etc., have been used within 6 months before surgery; 5. Patients diagnosed with secondary osteoporosis, such as osteoporosis secondary to the adrenal, gonads, thyroid, parathyroid, and other endocrine and metabolic diseases; 6. Diseases that may affect bone metabolism, such as infections and trauma; 7. Accompanying acute vertebral compression fracture 8. Having other systemic diseases, including severe lesions in important organs such as the heart, lungs, kidneys, and immune regulatory diseases; 9. Patients with moderate to severe depressive symptoms (Patient Health Questionnaire 9 [PHQ-9] score>9 points); 10. Patients with moderate to severe anxiety symptoms (GAD-7 score>5); 11. Individuals with a history of drug or alcohol abuse; 12. Unable to express their intentions correctly, unable to provide verbal guidance and cooperation; 13. Less than 3 months after participating in or completing other clinical trials; 14. Other researchers believe that it is not suitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone mineral density;VAS score;ODI score;Incidence of loose internal fixation; | — |
Countries
China
Contacts
Public ContactXue Li
Dujiangyan People's Hospital
Outcome results
None listed