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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011442
Receipt No. R000013397
Scientific Title Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.
Date of disclosure of the study information 2013/08/10
Last modified on 2013/08/10

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Basic information
Public title Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.
Acronym Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.
Scientific Title Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.
Scientific Title:Acronym Study of therapy with zoledronic acid in prostate cancer patients with bone metastases.
Region
Japan

Condition
Condition Prostate Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Observation of skeletal related events incidence and serach for risk factors of SREs in prostate cancer patients with bone metastases treated with zoledronic acid.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skeletal related events incidence
Key secondary outcomes Search for risk factors of SREs
(bone turnover markers, patient characteristics, PSA, bone pain, etc.)
Adverse events

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 prostate cancer patients with bone metastases are treated with zoledronic acid.
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
Key inclusion criteria 1)Patients with Histologically confirmed prostate cancer.
2) Patients with radiologic evidence of bone metastasis.
3) Patients with a life expectancy &#8805; 6 months.
4) Patient older than 20 years old.
5) Patients who give a written informed consent obtained.
Key exclusion criteria 1)Patients who have contraindications to zoledronic acid.
2)Patients without improvement of surgical wounds after invasive dental treatment.
3)Patients who have previously received zoledronic acid or denosumab.
4)Serum creatinine: more than 3.0mg/dL
5) Patient judged inappropriate for this study by the physicians
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Nonomura
Organization Osaka University Graduate School of Medicine
Division name Department of Organ Specific Regulation (Urology)
Zip code
Address 2-2 yamada-oka, Suita, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motohide Uemura
Organization Osaka University Graduate School of Medicine
Division name Department of Organ Specific Regulation (Urology)
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Osaka University Graduate School of Medicine,Department of Organ Specific Regulation (Urology)
Institute
Department

Funding Source
Organization none
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
2013 Year 08 Month 10 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
2013 Year 05 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 10 Day
Last modified on
2013 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013397

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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