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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018268
Receipt No. R000021144
Scientific Title Clinical investigation of change of bone-related marker between denosumab and zoledronic acid in patients with treatment-naive,bone-metastasis prostate cancer:prospective, multiinstitutional,cohort study
Date of disclosure of the study information 2015/12/01
Last modified on 2015/12/09

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Basic information
Public title Clinical investigation of change of bone-related marker between denosumab and zoledronic acid in patients with treatment-naive,bone-metastasis prostate cancer:prospective, multiinstitutional,cohort study
Acronym Comparative study between denosumab and zoledronic acid in terms of bone marker
Scientific Title Clinical investigation of change of bone-related marker between denosumab and zoledronic acid in patients with treatment-naive,bone-metastasis prostate cancer:prospective, multiinstitutional,cohort study
Scientific Title:Acronym Comparative study between denosumab and zoledronic acid in terms of bone marker
Region
Japan

Condition
Condition treatment-naive prostate cancer with bone metastasis
Classification by specialty
Hematology and clinical oncology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We compare denosumab with zoledronic acid in terms of change of bone markers in patients with treatment-naive,bone-metastasis prostate cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes change of bone marker
Key secondary outcomes adverse events, skeletal related event-free survival, PSA progression-free survival,change of renal function

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male
Key inclusion criteria treatment naive prostate cancer with bone metastasis, recurrent prostate cancer due to bone metastasis,performance status under 2
Key exclusion criteria history of radiation therapy to bone metastasis, history of dental treatment within 6 weeks of entry,Grade 4 renal insuffuciency such as eGFR under 30 or serum creatinine over 3
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun-ichi Hori
Organization Asahikawa Medical University
Division name Renal and Urologic Surgery
Zip code
Address Midorigaoka Higashi 2-1-1-1, Asahikawacity, Hokkaido
TEL 0166-68-2533
Email urohori@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun-ichi Hori
Organization Asahikawa Medical University
Division name Renal and Urologic Surgery
Zip code
Address Midorigaoka Higashi 2-1-1-1, Asahikawa city, Hokkaido
TEL 0166-68-2533
Homepage URL
Email urohori@asahikawa-med.ac.jp

Sponsor
Institute Department of Renal and Urologic Surgery, Asahikawa Medical University
Institute
Department

Funding Source
Organization Department of Renal and Urologic Surgery, Asahikawa Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Fukagawa city hospital, Furano kyoukai Hospital, Kitami red cross hospital, Megumino hospital, Kitasaito hospital,JR Sapporo Hospital
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
2015 Year 12 Month 01 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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multi-institutional, prospective, cohort study

We`ll observe 50 patients between December 1st 2015 to November 30th 2018 who go to our institution and related ones according to our already decided ctireria.

We`ll regulary investigate laboratry datas including bone-related markers at 3 months interval as well as CT, bone scintigraphy and bone mineral density at 6 months interval for 2 years.

Management information
Registered date
2015 Year 07 Month 10 Day
Last modified on
2015 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021144

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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