UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011442 |
|---|---|
| Receipt number | 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 11:14:37 |
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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 ≥ 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
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
Sponsor or person
Institute
Osaka University Graduate School of Medicine,Department of Organ Specific Regulation (Urology)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013397
