Necrosis of bone
Conditions
Interventions
Denosumab (Praria subcutaneous injection 60 mg)
Sponsors
Graduate School of Medicine, Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients falling under all the following conditions are targeted. 1. Male, female from ages 20 to 90 at the time of acquiring consent 2. MRI exhibits femoral head necrosis, knee bone necrosis, spinal vertebral body end plate degeneration (Modic denaturation), no decay necrosis 3. No cause of necrosis 4. The presence or absence of symptoms does not matter. 5. After receiving sufficient explanation for the participation of this study, patients who gained written consent by the patient's free will with sufficient understanding 6. Preventing and treating osteoporosis Guideline that meets the diagnostic criteria for osteoporosis according to the 2015 version
Exclusion criteria
Exclusion criteria: Those who fall under any of the following conditions are not included. 1. Patient with consciousness disorder 2. Patients with severe kidney disease (BUN 30 mg / dL or more, serum creatinine 2.0 mg / dL or more, eGFR ((ml / min / 1.73 m 2) 30 or less) 3. Patients with severe liver disease (AST (GOT), ALT (GPT) is 100 U or more) 4. When it is judged that mental illness or psychiatric symptoms are merged and it is difficult to participate in the exam 5. Women who may be pregnant, possibly pregnant, lactating women 6. Patients who can not keep hygiene in the oral cavity (For administration of medicines, confirm the administrated state in the oral cavity according to the attachment sentence of Pralia [Precautions for use] and, if necessary, In principle, guidance is given to instruct invasive dental procedures as much as possible, but patients who can not adhere to them should be excluded from this study) 7. Other responsibilities for examination (shared) Patients judged by physicians as inappropriate as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Side effects) Hypocalcemia, back pain, rise in gamma-GTP, hypertension, eczema, joint pain, atypical fracture, jaw bone necrosis, etc. | — |
Secondary
| Measure | Time frame |
|---|---|
| (Improvement of osteonecrosis) CT: CT value of the bone hardened part is measured by simple CT. MRI: Simple MRI is used to measure area of necrosis area in T1, T2 weighted images. (Secondary Evaluation Item of Effectiveness) Patient pain assessment | — |
Countries
Japan
Contacts
Public ContactKazuhide Inage
Graduate School of Medicine, Chiba University Dept. of Orthopaedic Surgery
Outcome results
None listed