Evaluation of Zoledronic Acid as a Single Agent or as an Adjuvant to Chemotherapy in High Grade Osteosarcoma

Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00691236

Acronym

ZOL

Enrollment

Registered

2008-06-05

Start date

2008-05-31

Completion date

2013-08-31

Last updated

2011-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma

Keywords

osteosarcoma, zoledronic acid, bisphosphonates, adjuvant to chemotherapy

Brief summary

This trial will be a pilot study to find out if zoledronic acid improves the response to chemotherapy in high grade osteosarcoma. In arm A of the study, 40 adult patients will be randomised into two groups. One group will get standard chemotherapy and the other group will get Zoledronic acid in addition to chemotherapy. The investigators will assess the histological necrosis as well as disease status for up to 2 years. In Arm B, adult patients with relapsed disease or advanced disease who are unable to take any other therapy and are given only symptomatic care will be given 6 doses of zoledronic acid and followed up for disease status. This will be to determine the role of zoledronic acid as a single agent.

Interventions

DRUGZoledronic acid

4mg IV 3 weekly for 6 doses

DRUGStandard chemotherapy

Adriamycin + Cisplatinum and Ifosfamide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
histological response disease free interval	2 years

Countries

India

Contacts

Primary ContactManish G Agarwal, M.S(Orth)

mgagarwal@gmail.com91-22-2444-7189

Backup ContactAjay Puri, M.S(Orth)

docpuri@vsnl.com91-22-2417-7183

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026