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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029737
Receipt No. R000033975
Scientific Title The development of forecasting technique for pregnancy-associated osteoporosis towards longer healthy life of women
Date of disclosure of the study information 2017/10/27
Last modified on 2017/10/27

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Basic information
Public title The development of forecasting technique for pregnancy-associated osteoporosis towards longer healthy life of women
Acronym The development of forecasting technique for pregnancy-associated osteoporosis
Scientific Title The development of forecasting technique for pregnancy-associated osteoporosis towards longer healthy life of women
Scientific Title:Acronym The development of forecasting technique for pregnancy-associated osteoporosis
Region
Japan

Condition
Condition pregnancy-associated osteoporosis
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The development of non-invasive forecasting techniques for pregnancy-associated osteoporosis in pregnant women without bone disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes bone mineral density in the lumbar spine and hip estimeted by dual-energy X-ray absorptiometry(DXA) ib the early postpartum
Key secondary outcomes bone mass reduction factors obtained from the questionnaire including fracture risk assessment tool(FRAX)

calcium intake during pregnancy

blood test value of bone metabolic markers during pregnancy

value of bone mass estimated by quantitative ultrasonometry(QUS) during pregnanvy

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit
48 years-old >=
Gender Female
Key inclusion criteria pregnant women without bone diseases
women who gave birth at term
Key exclusion criteria pregnant women with bone diseases
women who gave birth prematurely
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoko Kasahara
Organization Shiga University of Medical Science
Division name Department of Obstetrics and Gynecology
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2267
Email kasabee@shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoko Kasahara
Organization Shiga University of Medical Science
Division name Department of Obstetrics and Gynecology
Zip code
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2267
Homepage URL
Email kasabee@shiga-med.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Shiga University of Medical Science
Institute
Department

Funding Source
Organization In the application of scientific research fee
Organization
Division
Category of Funding Organization Other
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 滋賀医科大学附属病院(滋賀県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 27 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 04 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 The data is not obtained

Management information
Registered date
2017 Year 10 Month 27 Day
Last modified on
2017 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033975

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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