UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of utility of minodronic acid hydrate to osteoporosis by ovarian insufficiency after gynecologic disease treatment
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Sugiyama Michiyo
Organization	Gifu University
Division name	Obstetrics and Gynecology
Address	1-1 Yanagido,Gifu
TEL	058-230-6000
Email	michiyo@gifu-u.ac.jp

Public contact
Name of contact person	Sugiyama Michiyo
Organization	Gifu University
Division name	Obstetrics and Gynecology
Address	1-1 Yanagido,Gifu
TEL	058-230-6000
Homepage URL
Email	michiyo@gifu-u.ac.jp

Sponsor
Institute	Gifu University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009824