Zoledronic Acid in Decrease the Lung Metastatic Rate of O... | NCT03932071

Studies
Zoledronic Acid in Decrease the Lung Metastatic Rate of Osteosarcoma

NCT03932071

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

May 6, 2019Actual

Enrollment

150Estimated

Phase

Phase 4

Conditions

Lung Metastases
Tumor Necrosis

Interventions

Zoledronic Acid

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jan 1, 2020Estimated

Completion Date

Jan 1, 2023Estimated

First Submitted Date

Apr 26, 2019

First Submission Date that Met QC Criteria

Apr 26, 2019

First Posted Date

Apr 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2019

Last Update Posted Date

May 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhaoming Ye, Professor, Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPrincipal Investigator

Lead Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
experimental group	Experimental		Drug: Zoledronic Acid
control group	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic Acid	Drug		experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
rate of tumor necrosis less than 90%	the rate of patients that postoperative tumor necrosis rate was estimated to be lower than grade III（90%）	3 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaobo Yan, Dr.	Contact	+8613588153306		yanxiaobo82@gmail.com

Overall Officials

Name	Affiliation	Role
zhaoming Ye, Prof.	2nd Affiliated Hospital Of Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affiliated Hospital of Zhejiang University	Recruiting	Hangzhou	Zhejiang	310020	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077211	Zoledronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided