UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008422 |
|---|---|
| Receipt number | R000009905 |
| Scientific Title | Gastrointestinal Adverse effect with oral bisphophonate Survey |
| Date of disclosure of the study information | 2012/07/17 |
| Last modified on | 2014/10/18 08:53:56 |
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Basic information
Public title
Gastrointestinal Adverse effect with oral bisphophonate Survey
Acronym
GAP Survey Research
Scientific Title
Gastrointestinal Adverse effect with oral bisphophonate Survey
Scientific Title:Acronym
GAP Survey Research
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the relationship between the property of pepsinogen secretion and subjective symptom in patients who start administration of bisphosphonates for treatment of osteoporosis. These patietns will be examined to measure secretion of pepsinogen, or antibody against helico-bactor pyroli before the initiation of therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective sympotom derived from QOL inquiries at 1 or 3 months after initiation of bisphosphonate therapy.
Key secondary outcomes
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
Alendronic acid for 3 months
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Osteoporotic patients who initiate the first oral bisphosphonate therapy
Key exclusion criteria
1) Patient who has received bisphosphonates. However, after discontinuing these bisphosphonates for six months, it is possible to register.
2) Woman who are in pregnant or who hopes for pregnancy
3) Patient who has serious hepatopathy, renal damage, and cardiac disease
4) Patients judged as improper to participate for the clinical trial by physician in charge
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mika Yamauchi |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
Address
89-1, Enya-cho, Izumo city, Shimane 693-8501, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Yamauchi |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
Address
89-1, Enya-cho, Izumo city, Shimane 693-8501, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
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
山根病院（島根県）
雲南総合病院（島根県）
中岡クリニック（大阪府）
高槻病院（大阪府）
宮内内科クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 17 | 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
Completed
Date of protocol fixation
| 2009 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 13 | Day |
Last modified on
| 2014 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009905
