Trial Information
Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma
Inclusion Criteria:
1. Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high
grade osteosarcoma of the extremity
2. Non Metastatic at presentation. The metastases are ruled out by a CT scan of the
chest and a PET scan.
3. Patients are willing and able to afford the standard chemotherapy.
Exclusion Criteria:
1. Non-extremity sarcomas. (pelvis and spine)
2. Age less than 18 years or greater than 65 years
3. Metastatic at presentation
4. Pregnant or lactating women
5. Renal dysfunction in the form of elevated serum creatinine
6. Dental treatment anticipated after evaluation.
7. Patients who have received or are likely to receive steroids.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
histological response disease free interval
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Manish Agarwal, M.S(Orth)
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tata Memorial Hospital
Authority:
India: Ministry of Health
Study ID:
382
NCT ID:
NCT00691236
Start Date:
May 2008
Completion Date:
August 2013
Related Keywords:
- Osteosarcoma
- osteosarcoma
- zoledronic acid
- bisphosphonates
- adjuvant to chemotherapy
- Osteosarcoma