UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019700 |
|---|---|
| Receipt number | R000022758 |
| Scientific Title | Research for biomarkers to predict the effectiveness of denosumab in metastatic bone tumors |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2020/02/19 17:50:49 |
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Basic information
Public title
Research for biomarkers to predict the effectiveness of denosumab in metastatic bone tumors
Acronym
Research for biomarkers to predict the effectiveness of denosumab in metastatic bone tumors
Scientific Title
Research for biomarkers to predict the effectiveness of denosumab in metastatic bone tumors
Scientific Title:Acronym
Research for biomarkers to predict the effectiveness of denosumab in metastatic bone tumors
Region
| Japan |
Condition
Condition
Patients with bone metastases newly treated by denosumab
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between TRAP-5b, bone metabolic markers, and treatment effects
Basic objectives2
Others
Basic objectives -Others
Reaserch for biomarker
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Therapeutic effects of CT and bone scintigraphy (3 and 6 months after treatments)
Key secondary outcomes
Value and change of biomarkers, Pain score, Analgesic score, Side effect, PS
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
CT 3 times, bone scintigraphy 3 times, laboratory examination 4 times
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
Patients with bone metastases newly treated by denosumab
Key exclusion criteria
Fracture, No consent, Contraindication for denosumab
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Nishida |
Organization
Nagoya University Graduate School and School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
466-8550
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
052-744-1908
ynishida@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Urakawa |
Organization
Nagoya University Graduate School and School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
466-8550
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
052-744-1908
Homepage URL
urakawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School and School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School and School of Medicine
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
Nagoya University Ethics Committee
Address
65 Tsurumai, Showa-ku, Nagoya
Tel
052-741-2111
iga-sou1@adm.med.nagoya-u.ac.jp
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 | 11 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
| 2013 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2020 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022758
