UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045408
Receipt number R000051848
Scientific Title The effect of geometric bone quality on bone strength in patients with secondary osteoporosis: Cross-sectional observational research
Date of disclosure of the study information 2021/09/07
Last modified on 2021/09/07 18:20:07

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Basic information

Public title

The effect of geometric bone quality on bone strength in patients with
secondary osteoporosis: Cross-sectional observational research

Acronym

The effect of geometric bone quality on bone strength in patients with
secondary osteoporosis: Cross-sectional observational research

Scientific Title

The effect of geometric bone quality on bone strength in patients with
secondary osteoporosis: Cross-sectional observational research

Scientific Title:Acronym

The effect of geometric bone quality on bone strength in patients with
secondary osteoporosis: Cross-sectional observational research

Region

Japan


Condition

Condition

Osteoporosis

Classification by specialty

Endocrinology and Metabolism Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to elucidate the role of bone microarchitecture on bone fragility in patients with secondary osteoporosis.

Basic objectives2

Others

Basic objectives -Others

This study aims to identify factors causing bone fragility

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Vertebral fracture
bone microarchitecture

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have attended the Department of Endocrinology and Metabolism, Shimane University Hospital between April 1, 1998, and March 31, 2021.

Key exclusion criteria

Nothing particular

Target sample size

1150


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Yamamoto

Organization

Shimane University Faculty of Medicine

Division name

Internal medicine 1

Zip code

693-8501

Address

89-1 Enya-cho, Izumo, Shimane

TEL

0853-20-2183

Email

masa-ya@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Yamamoto

Organization

Shimane University Faculty of Medicine

Division name

Internal medicine 1

Zip code

693-8501

Address

89-1 Enya-cho, Izumo, Shimane

TEL

0853-20-2183

Homepage URL


Email

masa-ya@med.shimane-u.ac.jp


Sponsor or person

Institute

Shimane University

Institute

Department

Personal name



Funding Source

Organization

Shimane University

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

Shimane University Hospital, Clinical Trial Review Board

Address

89-1 Enya-cho, Izumo, Shimane

Tel

0853-20-2515

Email

kenkyu@med.shimane-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

2021 Year 09 Month 07 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

2021 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2021 Year 10 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will investigate the effect of bone microarchitecture on bone fragility in patients with secondary osteoporosis.


Management information

Registered date

2021 Year 09 Month 07 Day

Last modified on

2021 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051848


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name