osteoprosis
Conditions
Interventions
Experimental group:zoledronic acid infusion
Control group:placebo
Sponsors
Affiliated Kunshan Hospital of Jiangsu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. single-level primary OVCF in the thoracolumbar or lumbar area within 2 weeks; 2. MRI showing a hypointense signal on T1-weighted images and hyperintense signal on T2-weighted images; 3. Patients presented with lower back pain, local spinous process tenderness, and/or the corresponding vertebral body pain with percussion.
Exclusion criteria
Exclusion criteria: 1. Secondary vertebral fractures or secondary osteoporosis including fractures related to malignancy, infection, or other medical conditions; 2. clinically significant neurologic deficit before and after surgery; 3. Patients with breaks in the posterior vertebral body wall; 4. patients with intervertebral cleft; 5. life-threatening systemic disease, such as malignancy, systemic infection, or serious disorder of a vital organ; 6. patients who were contradicted to zoledronic acid or who were allergic to any components of zoledronic acid or other bisphosphonates regiments; 7. patients with a serum total calcium level of less than 2.13 mmol/L; 8. patients with a Cockcroft calculated creatinine clearance of less than 35 mL/min; 9. History of use of anti-osteoporosis drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vertebral height lost rate;recompression vertebral fractures;new vertebral fractures; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale and Oswestry Disability Index Scores;Bone Mineral Density and Biochemical Markers; | — |
Countries
China
Contacts
Public ContactKe Lu
Affiliated Kunshan Hospital of Jiangsu University
Outcome results
None listed