UMIN-CTR Clinical Trial

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
Institute	Shimane University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051848