osteoporosis
Conditions
Interventions
Zoledronic acid group:None
Sponsors
Tangdu Hospital, Air Force Medical University
Eligibility
Sex/Gender
Female
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) The patient agrees to participate in the study and signs an informed consent form; 2) Due to spinal degenerative diseases such as lumbar spinal stenosis, lumbar disc herniation, degenerative lumbar spondylolisthesis, or degenerative spinal deformities, conservative treatment has poor results. The postmenopausal women who undergo MI-TLIF surgery with single-stage bilateral pedicle screw fixation are aged 50 to 85 years (including 50 and 85 years); 3) The absolute value of bone mineral density (BMD) in the lumbar or total hip area of the patient conforms to a T-value of -4.0; 4) Postmenopausal, defined as occurring after the age of 40 and lasting for more than 2 years (calculated from the date of signing the informed consent form), can be spontaneous amenorrhea lasting more than 2 years or bilateral oophorectomy lasting more than 2 years. If the status of bilateral oophorectomy is unknown, use follicle stimulating hormone (FSH) levels greater than 40 mIU/mL to confirm surgical menopause; 5) Plan to receive treatment with denosumab or zoledronic acid injection after surgery.
Exclusion criteria
Exclusion criteria: 1) Diseases that can affect bone metabolism a.Various metabolic bone diseases, such as osteomalacia or osteogenesis imperfecta, may interfere with research results; b. Paget's disease; c. Cushing's syndrome; d. Hyperprolactinemia; e. Other 2) Currently, there is hyperparathyroidism or hypoparathyroidism; 3) Hyperthyroidism or hypothyroidism. Patients with hypothyroidism who only receive stable (at least 3 months) thyroid hormone replacement therapy can be selected, but they must meet the following conditions: a. If TSH levels are below the normal range, the patient cannot participate in the study. b. If TSH levels are elevated (>5.5 µ IU/mL but = 2.9mmol/L (11.5mg/dL); Patients are not allowed to use calcium supplements for at least 8 hours before blood is drawn for serum calcium screening. 13) DXA measurement: a. Less than 2 lumbar vertebrae can be measured by DXA; b. Height, weight, or waist circumference may hinder the accurate measurement of DXA; 14) History of more than 2 v
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lumbar interbody fusion rate at 12 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lumbar interbody fusion rate at 6 months after operation;The loosening rate of pedicle screw at 6 and 12 months after operation;Settlement rate of intervertebral implants at 6 and 12 months after operation;Levels of bone metabolic markers at 1, 3, 6, and 12 months after surgery;Bone mineral density at 6 and 12 months after operation;Oswestry disability index at 1, 3, 6, and 12 months after operation;Quality of life at 1, 3, 6, and 12 months after operation;Incidence of revision surgery;postoperative complications;Adverse events (AEs);Safety measures; | — |
Countries
China
Contacts
Public ContactGuo Zheng
Tangdu Hospital, Air Force Medical University
Outcome results
None listed