Benign osteolytic bone tumors in adolescents (Langerhans cell hyperplasia, fibrous dysplasia and aneurysmal bone cyst)
Conditions
Interventions
case series:denosumab
Sponsors
Shanghai Changzheng hospital
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged 13 to 18 years old, both male and female; 2. Confirmed by histopathology and / or cytology: LCH; aneurysmal bone cyst; fibrous dysplasia; etc; 3. Have not received any treatment in the past; 4. Imaging (CT, MRI) confirmed the presence of bone structure changes, measurable osteolytic lesions; 5. Mild symptoms (mainly pain symptoms; no hospitalization); no nerve compression symptoms (Frankel score: e); no obvious spinal instability (SINS score: 0-12); no fracture; 5; 6. The function of the main organs is normal and meets the following requirements: (1) Blood routine examination should be consistent with (no blood transfusion within 14 days) HB>=90g/L; ANC >=1.5x10^9/L; PLT >=80x10^9/L; (2) Biochemical examination should meet the following standards: Bil =50ml/min (Cockcroft Gault formula); 7. The expected survival time is more than 3 months; 8. The doctors plan to use conservative treatment; 9. The patient's Guardian voluntarily joined the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Bone lesions not confirmed by pathological biopsy; 2. Severe spinal cord compression, spinal instability and fracture must be treated with surgery and internal fixation 3. Have received other surgery or related treatment before; 4. Participating in other randomized controlled trials (RCTs); 5. Unable to complete the follow-up or questionnaire, poor compliance; 6. Combined with other systemic diseases, the patients can not be included in the group or can not be treated regularly for a long time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BTM;PFS;BDM;ORR;life quality score;RANKL IHC; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;adverse event; | — |
Countries
China
Contacts
Public ContactJianru Xiao
Shanghai Changzheng Hospital
Outcome results
None listed