UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The development of forecasting technique for pregnancy-associated osteoporosis towards longer healthy life of women
Title of the study (Brief title)	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	Kyoko Kasahara
Organization	Shiga University of Medical Science
Division name	Department of Obstetrics and Gynecology
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2267
Email	kasabee@shiga-med.ac.jp

Public contact
Name of contact person	Kyoko Kasahara
Organization	Shiga University of Medical Science
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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