UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012143 |
|---|---|
| Receipt number | R000014193 |
| Scientific Title | Estimation of usefulness of intravenous admnistration of alendoronate for bone disorders after gastrectomy |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2017/10/31 15:34:24 |
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Basic information
Public title
Estimation of usefulness of intravenous admnistration of alendoronate for bone disorders after gastrectomy
Acronym
Estimation of usefulness of intravenous admnistration of alendoronate for bone disorders after gastrectomy
Scientific Title
Estimation of usefulness of intravenous admnistration of alendoronate for bone disorders after gastrectomy
Scientific Title:Acronym
Estimation of usefulness of intravenous admnistration of alendoronate for bone disorders after gastrectomy
Region
| Japan |
Condition
Condition
Distrubances of bone tissue metabolism
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the usefulness of orally administered jelly alendoronate and intravenously administered alendronate in patients receiving gastrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Bone mineral density (L1-4)
Key secondary outcomes
1. Bone mineral density of the total hip
2. Bone turnover markers (serum BAP, serum NTx, Serum TPACP-5b)
3. Adverse effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravnous alendoronate group:
Intravenous administration of 100 ml of alendronate at once per month.
One course is one month and this treatment is continued 12 courses.
Interventions/Control_2
Jelly alendronate group:
A 35 mg of jelly type alndronate was orally administered at once per week One course is one month and this treatment is continued 12 courses..
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
1. Patients aged more than 20 years .
2. Patients with osteoporosis diagnozed by DXA method (definition of osteoporosis: YAM value is under 80 %)
3. Patients underwent gastrectomy
4. Patients with bone fracture or YAM value is under -1.5SD.
5. Patients without treatments for malignancies
6. Patients without past history of invasive dental treatments within 3 months
7. Patients who gaved informed consent.
Key exclusion criteria
1. Patients with some diseaes which may be worse by the participation of this study.
2. Pregnant patients or patients who hope pregnancy
3. Patients who are judged inappropriate by doctors
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikara Kunisaki |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
s0714@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirochika Makino |
Organization
Gastroenterological Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
hirochika@hotmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | 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
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 | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 28 | Day |
Last modified on
| 2017 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014193
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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