UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027959 |
|---|---|
| Receipt number | R000032028 |
| Scientific Title | Longitudinal comparison of bone mass and bone quality before and after treatment with eldecalcitol in the patients with Turner syndrome and low bone mass even after HRT |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2017/06/28 01:41:14 |
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Basic information
Public title
Longitudinal comparison of bone mass and bone quality before and after treatment with eldecalcitol in the patients with Turner syndrome and low bone mass even after HRT
Acronym
Longitudinal comparison of bone mass and bone quality before and after treatment with eldecalcitol in the patients with Turner syndrome and low bone mass even after HRT
Scientific Title
Longitudinal comparison of bone mass and bone quality before and after treatment with eldecalcitol in the patients with Turner syndrome and low bone mass even after HRT
Scientific Title:Acronym
Longitudinal comparison of bone mass and bone quality before and after treatment with eldecalcitol in the patients with Turner syndrome and low bone mass even after HRT
Region
| Japan |
Condition
Condition
Turner syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes in bone mass and bone quality when eldecalsitol was used concomitantly with HRT in the patients with Turner syndrome and low bone mass even after HRT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
urinary pentosidine
Key secondary outcomes
bone mineral density (BMD)
urinary cross-linked N-telopeptides of type I collagen (uNTX)
serum intact procollagen type I N-terminal propeptide (intact-P1NP)
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1) patients with Turner syndrome and low bone mass even after HRT
2) Patients enable to informed consent in document
Key exclusion criteria
1) Patients with untreated mental disorder
2) Patients who judged as inappropriate for this study by the attending physician
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideya Sakakibara |
Organization
Yokohama City University Medical Center
Division name
Gynecology
Zip code
Address
4-57 Urafunecho Minamiku, Yokoahama
TEL
045-261-5656
sakakih@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Tsuburai |
Organization
Yokohama City University Medical Center
Division name
Gynecology
Zip code
Address
4-57 Urafunecho Minamiku, Yokoahama
TEL
045-261-5656
Homepage URL
tsubutsububuu@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Medical Center
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
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
横浜市立大学附属市民総合医療センター（神奈川）、横浜市立大学附属病院（神奈川）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 28 | 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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2017 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032028
