UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015517 |
|---|---|
| Receipt number | R000017604 |
| Scientific Title | Prospective randomised clinical trial for the medication in Metabolic Bone Diseases after Gastrectomy |
| Date of disclosure of the study information | 2014/10/24 |
| Last modified on | 2014/10/25 18:42:03 |
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Basic information
Public title
Prospective randomised clinical trial for the medication in Metabolic Bone Diseases after Gastrectomy
Acronym
Prospective randomised clinical trial for the medication in Metabolic Bone Diseases after Gastrectomy
Scientific Title
Prospective randomised clinical trial for the medication in Metabolic Bone Diseases after Gastrectomy
Scientific Title:Acronym
Prospective randomised clinical trial for the medication in Metabolic Bone Diseases after Gastrectomy
Region
| Japan |
Condition
Condition
Osteoporosis after gastrectomy
Classification by specialty
| Gastrointestinal surgery | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of monthly minoodronic acid hydrate for the osteoporosis after gastrectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density (BMD) of the lumber spine
Key secondary outcomes
Bone mineral density (BMD) of the proximal thighbone
adverse event
The ratio of the patients who completed the treatment
bone metabolism marker(BAP NTX)
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The Minodolon acid hydrate administrated group
Interventions/Control_2
The eldecalcitol administrated group
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients for gastric cancer patients, who was operated gastrectomy for over three years
Performance status(0-2)
the case that was provided of the agreement.
Key exclusion criteria
Patients who cannot use Minodronic acid hydrate
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Doki Yuichiro |
Organization
Osaka university graduate school of medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2 E2 Yamadaoka, Suita city, Osaka
TEL
+81-6-6879-3251
ttakahashi2@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahashi Tsuyoshi |
Organization
Osaka university graduate school of medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2 E2 Yamadaoka, Suita city, Osaka
TEL
+81-6-6879-3251
Homepage URL
ttakahashi2@gesurg.med.osaka-u..ac.jp
Sponsor or person
Institute
Osaka university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka university graduate school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2014 | Year | 10 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 14 | 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
| 2014 | Year | 10 | Month | 24 | Day |
Last modified on
| 2014 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017604
