Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
The Efficacy of New Adjuvant Chemotherapy of Osteosarcoma Combined With Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma
1 other identifier
interventional
150
1 country
1
Brief Summary
Zoledronic acid is an adjuvant treatment for primary osteosarcoma. Zoledronic acid has been widely used in the treatment of metastatic bone tumors. In addition to its inhibition of tumor osteoclasis, it also produces certain killing of tumor cells. effect. Foreign studies have shown that zoledronic acid also has a killing effect on osteosarcoma and has a certain inhibitory effect on distant metastasis. We hope that it can reduce tumor recurrence and lung metastasis through this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2017
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 26, 2019
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedMay 6, 2019
May 1, 2019
3 years
April 26, 2019
May 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
rate of lung metastasis
Discovery the rate of neonatal lung metastases by high-resolution chest CT
3 year
rate of tumor recurrence
Local recurrence rate of tumor or rate of distant metastasis
3 year
Secondary Outcomes (1)
rate of tumor necrosis less than 90%
3 year
Study Arms (2)
experimental group
EXPERIMENTALcontrol group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Patients with osteosarcoma who were diagnosed with initial pathology and pathology were excluded from lung metastasis or other metastatic lesions by CT and total body emission-computed tomography, and patients with standard chemotherapy were evaluated.
You may not qualify if:
- Pulmonary metastasis, pregnancy or lactation, renal insufficiency (creatinine clearance \<70 ml/min/1.73 m2), liver dysfunction, obvious oral disease, and unsuitable for bisphosphonate treatment after evaluation, have been found. With diseases that still require hormone therapy, abnormal blood system, heart disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
2nd Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310020, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
zhaoming Ye, Prof.
2nd Affiliated Hospital Of Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 26, 2019
First Posted
April 30, 2019
Study Start
January 1, 2017
Primary Completion
January 1, 2020
Study Completion
January 1, 2023
Last Updated
May 6, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share