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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name