Health Condition 1: D169- Benign neoplasm of bone and articular cartilage, unspecified
Conditions
Interventions
Intervention1: injection Denosumab: Patients received 120 mg denosumab subcutaneously once every 4 weeks, with loading doses (120 mg subcutaneously) administered on study days 8 and 15.
Control Inte
Sponsors
Dr Sanyam Rathi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed cases of Giant Cell Tumour Of Bone 2. Patients with no medical contraindication 3. Adults or skeletally mature adolescents (aged =12 years) weighing at least 45 kg , a Karnofsky performance status of 50% or higher (or Eastern Cooperative Oncology Group status 0, 1, or 2), and measurable active disease within 1 year of study enrolment. 4. Campanacci grades 2 and 3 will be included that is II- Extensive intaosseous lesion with thin cortex, cortical continuity III- Destructive radiolucent lesion with cortical break and soft tissue extension)
Exclusion criteria
Exclusion criteria: 1. Age of patients less than 12 years 2. Patients with active local infection at the site. 3. Patients with a known or suspected diagnosis of sarcoma, non-GCTB giant-cell-rich tumours, brown cell tumour of bone, or Paget disease; patients with a history or current evidence of osteonecrosis or osteomyelitis of the jaw; or those who required oral surgery or had unhealed dental or oral surgery are excluded 4. Pregnant Females 5. Patients hypersensitive to denosumab or any of the components of formulation 6. Preexisting hypocalcemia 7. Campanacci Grade I I-Intraosseous lesion with Intact Cortex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk benefit ratio of using Denosumab in the management of Giant Cell Tumour.Timepoint: Every 4 weeks till the end of 1 year from the starting of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Sanyam Rathi
Gauhati Medical College and Hospital
Outcome results
None listed