UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029737 |
|---|---|
| Receipt number | 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 12:31:45 |
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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
| Obstetrics 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
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
kasabee@shiga-med.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033975
