refracture after vertebral augmentation
Conditions
Interventions
test group:Subcutaneous injection of denosumab
Control group:Oral alendronate sodium
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
Male
Age
51 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Females aged over 50 years; 2. Bone mineral density T value measured by dual energy X-ray absorptiometry <= -2.5 SD (any part of lumbar spine, total hip and femoral neck); 3. Patients with vertebral body compression fractures confirmed by imaging examination, who will be admitted to hospital for PVP surgery; 4. No regular anti-osteoporosis treatment within 6 months; 5. The patient gave informed consent and accepted the treatment by this method.
Exclusion criteria
Exclusion criteria: 1. Pathological fracture; 2. Patients with secondary osteoporosis; 3. Long-term use of drugs that affect bone metabolism, such as diuretics, heparin, glucocorticoids, etc.; 4. Old fractures; 5. Previously suffering from rheumatism and rheumatoid diseases; 6. Those with coagulation dysfunction; 7. Mental disorders; 8. Patients with high blood pressure, diabetes, and major diseases such as heart, brain, lung, liver, and kidney, who cannot tolerate surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Refracture rate within 18 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| BMD, bone mineral density;Bone turnover markers (blood Ca/P, PINP, S-CTX, etc.);medication compliance;Liver and kidney function;Dysfunction Index;VAS, Visual Analogue Scale;Other laboratory indicators; | — |
Countries
China
Contacts
Public ContactChen Hao
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed