UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038531
Receipt number R000043913
Scientific Title Analysis of bone microstructure using second-generation high-resolution peripheral quantitative computed tomography (HR-pQCT) in patients with primary aldosteronism
Date of disclosure of the study information 2019/11/10
Last modified on 2021/04/12 20:17:53

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Basic information

Public title

Analysis of bone microstructure using second-generation high-resolution peripheral quantitative computed tomography (HR-pQCT) in patients with primary aldosteronism

Acronym

Analysis of bone microstrucure using HR-pQCT in primary aldosteronism

Scientific Title

Analysis of bone microstructure using second-generation high-resolution peripheral quantitative computed tomography (HR-pQCT) in patients with primary aldosteronism

Scientific Title:Acronym

Analysis of bone microstrucure using HR-pQCT in primary aldosteronism

Region

Japan


Condition

Condition

Primary aldosteronism

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyse bone mictrostructural change using second generation HR-pQCT in Japanese patients with primary aldosteronism.

Basic objectives2

Others

Basic objectives -Others

Observational study of bone microstructure

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bone microstructure compared to those of healthy control.

Key secondary outcomes

Changes in bone microstructure in patients with primary aldosteronism from baseline to 1 or 2 years after adrenalectomy.


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with primary aldosteronism based on the criteria of Japan Endocrine socitety

Key exclusion criteria

1. Patients treated at present or within 12 months with bisohosphonate, teriparatide, denosumab and romosozumab.
2. Patinets administered with steroids.
3. Patients compricated with malignancy.
4. Pregnant or brest feeding.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Horie
Middle name
Last name Ichiro

Organization

Nagasaki University Hospital

Division name

Department of Endocrinology and Metabolism

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki

TEL

0958197262

Email

horie@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Horie
Middle name
Last name Ichiro

Organization

Nagasaki University Hospital

Division name

Department of Endocrinology and Metabolism

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki

TEL

0958197262

Homepage URL


Email

horie@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University Hospital

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

Department of Endocrinology and Metabolism

Address

1-7-1 Sakamoto, Nagasaki

Tel

0958197200

Email

horie@nagasaki-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 11 Month 10 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

Enrolling by invitation

Date of protocol fixation

2019 Year 11 Month 10 Day

Date of IRB

2020 Year 01 Month 21 Day

Anticipated trial start date

2020 Year 01 Month 01 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry

2029 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

No other imformation


Management information

Registered date

2019 Year 11 Month 10 Day

Last modified on

2021 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043913


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name