UMIN-CTR Clinical Trial

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
Last 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
1st 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