UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016345
Receipt number R000018967
Scientific Title To clarify the effects of anti-osteoporosis drugs on preventing patients from areterial calcification. A multicentric study.
Date of disclosure of the study information 2015/02/10
Last modified on 2019/07/31 16:00:11

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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 or person

Institute

Saitama medical university

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018967


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name