UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005665 |
|---|---|
| Receipt number | R000006697 |
| Scientific Title | Examination of utility of bisphosphonate to osteoporosis by ovarian insufficiency after gynecologic cancer treatment |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2015/05/28 10:51:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of utility of bisphosphonate to osteoporosis by ovarian insufficiency after gynecologic cancer treatment
Acronym
Examination of utility of bisphosphonate to osteoporosis after gynecologic cancer treatment
Scientific Title
Examination of utility of bisphosphonate to osteoporosis by ovarian insufficiency after gynecologic cancer treatment
Scientific Title:Acronym
Examination of utility of bisphosphonate to osteoporosis after gynecologic cancer treatment
Region
| Japan |
Condition
Condition
Osteoporosis after gynecologic cancer treatment
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the effects of bisphosphonate to bone loss and osteoporosis after gynecologic cancer treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of bone mineral density and biochemical markers of turnover after two years from administering beginning
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
Administering the bisphosphonate BENET Tablets 17.5mg once a week for two years
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Cases that diagnosed as bone loss and osteoporosis by DXA method after oophorectomy or radiation therapy for gynecologic cancer
Key exclusion criteria
1)Cases that are impossible to measure by DXA and judge bone fractures
2)Cases that receive administering bisphosphonates before start of this examination
3)Cases that have advanced renal damage
4)Cases that have upper digestive canal disturbance
5)Cases that receive resection of stomach and wide gut
6)Cases that have previous history of hypersensitivity for elements of this medicine and other bisphosphonates
7)Cases with hypocalcemia
8)Cases that cannot keep upright or sitting positioning for 30 minutes or more when taking it
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sugiyama Michiyo |
Organization
Gifu University
Division name
Obstetrics and Gynecology
Zip code
Address
1-1 Yanagido,Gifu
TEL
058-230-6000
michiyo@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sugiyama Michiyo |
Organization
Gifu University
Division name
Obstetrics and Gynecology
Zip code
Address
1-1 Yanagido,Gifu
TEL
058-230-6000
Homepage URL
michiyo@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
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
| 2011 | Year | 06 | Month | 01 | 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
| 2011 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | 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
| 2011 | Year | 05 | Month | 27 | Day |
Last modified on
| 2015 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006697
