UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the diagnostic method based on the Study of the diagnostic method on the Prediction of bone strength by a quantitative computed tomography-based finite element method
Title of the study (Brief title)	Study on the diagnosis by the finite element method
Region	Japan

Condition
Condition	Osteoporosis
Classification by specialty	Endocrinology and Metabolism Geriatrics Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To track the transition of the predicted bone strength value by the bone density values and the CT finite element method by DXA before and after the treatment of osteoporosis intervention, to compare the sensitivity of the therapeutic effect of each diagnostic method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Predicted Bone strength 0,6,12,24months
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	medical treatment with minodronic acid Period of 24 months
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	Osteoporosis was diagnosed based on Diagnostic criteria for primary osteoporosis : year 2012 revision
Key exclusion criteria	Exclusion criteria included those who had any recent or current treatment with the potential to alter bone turnover or bone metabolism, patients with dementia, those who could not walk, patients with malignancy, and those who could not take orally bisphosphonate.
Target sample size	20

Research contact person
Name of lead principal investigator	HIROSHI OKAZAKI
Organization	Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Division name	Orthopedics
Address	1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki City, Kanagawa Prefecture
TEL	044-411-3131
Email	okazarov@kantoh.rofuku.go.jp

Public contact
Name of contact person	MASAKO KANEKO
Organization	Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Division name	Orthopedics
Address	1-1 Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki City, Kanagawa Prefecture
TEL	044-411-3131
Homepage URL
Email	masako-k@umin.net

Sponsor
Institute	Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	関東労災病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 06 Month 30 Day
Date trial data considered complete	2020 Year 08 Month 31 Day
Date analysis concluded	2020 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 29 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024327