se of Injection Denosumab in the treatment of Giant Cell Tumour.
- Conditions
- Health Condition 1: D169- Benign neoplasm of bone and articular cartilage, unspecified
- Registration Number
- CTRI/2024/02/062905
- Lead Sponsor
- Dr Sanyam Rathi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ILTimepoint: NI