CTRI/2024/02/062905
Not yet recruiting
Phase 2
Functional Outcome of Denosumab in the management of Giant Cell Tumour of Bone. - NI
Dr Sanyam Rathi0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: D169- Benign neoplasm of bone and articular cartilage, unspecified
- Sponsor
- Dr Sanyam Rathi
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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