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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009675
Receipt No. R000010707
Scientific Title Pilot study of index and safety of switching to Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Date of disclosure of the study information 2012/12/31
Last modified on 2019/04/15

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Basic information
Public title Pilot study of index and safety of switching to Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Acronym Pilot study of Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Scientific Title Pilot study of index and safety of switching to Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Scientific Title:Acronym Pilot study of Denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Region
Japan

Condition
Condition hepatocellular carcinoma with bone metastasis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the efficacy and safety of switching to denosumab from Zoledronic acid for hepatocellular carcinoma with bone metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Marker of bone resorption
Key secondary outcomes Brief Pain Inventory score,
Decreasing rate of marker of bone resorption compared to pre-treatment,
Adverse events(renal dysfunction, serum Ca value, osteonecrosis of the jaw)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 denosumab
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosis of HCC was confirmed histopathologically.
2) With bone metastasis.
3) With progression of bone metastasis despite of using Zoledronic acid.
4) age > 20
5) PS 0-2
6)
a)WBC > 3000/mm3
b)Hb > 9.0 g/dl
c)Plt > 75000/mm3
d)Creatine < 3.0mg/dl
e)serum Ca >8.5mg/dL,<11.5mg/dL
f)Total Bilirubin < 1.8 mg/dl
g)AST <90IU/L
h)ALT <100IU/L
7) Written Informed Consent must be obtained.
Key exclusion criteria 1) CCr < 30
2) A pregnant woman, or a woman suspected of pregnancy.
10) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
3) With odontogenic infection.
4) Patients participating in other clinical trial.
5) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Chayama
Organization Hiroshima University Hospital
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Aikata
Organization Hiroshima University Hospital
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5191
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 11 Month 15 Day
Date of IRB
2012 Year 12 Month 05 Day
Anticipated trial start date
2012 Year 12 Month 10 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 12 Month 31 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010707

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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