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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008353
Receipt No. R000009824
Scientific Title Examination of utility of minodronic acid hydrate to osteoporosis by ovarian insufficiency after gynecologic disease treatment
Date of disclosure of the study information 2012/07/09
Last modified on 2016/07/05

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Basic information
Public title Examination of utility of minodronic acid hydrate to osteoporosis by ovarian insufficiency after gynecologic disease treatment
Acronym Examination of utility of minodronic acid hydrate to osteoporosis after gynecologic disease treatment
Scientific Title Examination of utility of minodronic acid hydrate to osteoporosis by ovarian insufficiency after gynecologic disease treatment
Scientific Title:Acronym Examination of utility of minodronic acid hydrate to osteoporosis after gynecologic disease treatment
Region
Japan

Condition
Condition Osteoporosis after gynecologic disease treatment
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analyze the effects of minodronic acid hydrate to bone loss and osteoporosis after gynecologic disease 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 minodronic acid hydrate Bonoteo Tablets 50mg once a month 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 ,and that have a more than 15% probability of bone fracture in the next 10 years by FRAX ,is a diagnostic tool used to evaluate bone fracture risk, by ovarian insufficiency after gynecologic disease treatment
Key exclusion criteria 1)Cases with a history of serious drug sensitivity or allergy
2)Cases with diseases that are likely to delay esophageal transit such as esophagus stenosis or achalasia
3)Cases that cannot keep upright or sitting positioning for 30 minutes or more when taking it
4)Cases that be judged inadequate for for this study
Target sample size 30

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
Email 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
Email michiyo@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

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
Email

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
2012 Year 07 Month 09 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
2012 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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
2012 Year 07 Month 05 Day
Last modified on
2016 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009824

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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