UMIN-CTR Clinical Trial

Basic information
Public title	To clarify the effects of anti-osteoporosis drugs on preventing patients from areterial calcification. A multicentric study.
Acronym	The effects of anti-osteoporosis drugs on prevention of areterial calcification
Scientific Title	To clarify the effects of anti-osteoporosis drugs on preventing patients from areterial calcification. A multicentric study.
Scientific Title:Acronym	The effects of anti-osteoporosis drugs on prevention of areterial calcification
Region	Japan

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

Objectives
Narrative objectives1	This study is conducted to clarify difference of extents of areterial cacification between osteoporsis patients with treatments and without treatment.
Basic objectives2	Others
Basic objectives -Others	To clarify the secondary effects of anti-soteoporotic drugs
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Whether there are differences of calcification in aorta, abdominal aretery, or iliac artery between osteoporosis patients with treatmets and without treatment
Key secondary outcomes	1. Wheter there are correlation between severity of osteoporosis and severity of arterial calcification. 2. Wheter there are different effects of anti-osteoporotic drugs on prevention of arterial calcification

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	50 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients with primary osteoporosis, compatible to Japanese criteron of primary osteoporosis a revised edition in 2012. 2. Patients with glucocorticod induced osteoporosis, compatible to guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese society of bone and mineral research, 2014 update.
Key exclusion criteria	1. Metabolic bone diseases other than osteoporosis 2. Serious renal, hepatic, or cardiac disease 3. Patients who are considered appropriate for enrollement by the investigator.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinya Tanaka
Organization	Saitama medical university
Division name	Orthopaedic surgery
Zip code
Address	38, Morohongo, Moroyama-cho, Iruma-gun, Saitama
TEL	+81-49-276-1238
Email	tnk_sny@saitama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shinya Tanaka
Organization	Saitama medical university
Division name	Orthopaedic surgery
Zip code
Address	38, Morohongo, Moroyama-cho, Iruma-gun, Saitama
TEL	+81-49-276-1238
Homepage URL
Email	tnk_sny@saitama-med.ac.jp

Sponsor
Institute	Saitama medical university
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Akita university
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

Other administrative information
Date of disclosure of the study information	2015 Year 02 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	Terminated
Date of protocol fixation	2015 Year 01 Month 26 Day
Date of IRB	2015 Year 02 Month 09 Day
Anticipated trial start date	2015 Year 02 Month 09 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nothing

Management information
Registered date	2015 Year 01 Month 26 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018967