osteoporotic vertebral compression fractures
Conditions
Interventions
Experimental group:zoledronate
Control group:placebo
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. The patient's aged 40 to 90 years; 2. X-ray diagnosis of 1 or 2 vertebral body compression fractures; 3. The BMD T value detected by DEXA is less than -1; 4. The duration of fracture history is within 6 weeks; 5. There is bone marrow edema in the injured segment on MRI; 6. Lower back pain and local spinous process tenderness.
Exclusion criteria
Exclusion criteria: 1. Patients with intervertebral fissure; 2. Infection; 3. Malignant tumor; 4. Neurological dysfunction; 5. Previous back surgery and other established contraindications for elective surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| osteocalcin in the N terminal molecular fragment;n-terminal propeptide P1NP of procollagen type 1;c-terminal crosslinking type 1 collagen terminal peptide CTx;serum total calcium;parathyroid hormone;total phosphorus;total alkaline phosphatase;albumin;Dual - energy X-ray examination of lumbar spine bone mineral density;hip bone mineral density;computed tomography for bone fracture segment;Bone marrow edema and adjacent intervertebral disc were detected by Magnetic Resonance Imaging;Fracture segments;anti-osteoporosis medications;symptom duration;vertebral height loss;Genant grade;nonsteroidal pain medication use;cobb angle;Numeric Rating Scale for Pain;Visual Analogue Scale pain questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Roland Morris disability function Questionnaire;Osteoporosis QUALEFO-31 questionnaire;EQ-5D quality of life questionnaire; | — |
Countries
China
Contacts
Public ContactWang Hongyu
Shenzhen People's Hospital
Outcome results
None listed