UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018306
Receipt number R000021190
Scientific Title Osteoporosis screening using FRAX by community pharmacists and Collaborative pharmacotherapy in the osteoporotic treatment
Date of disclosure of the study information 2015/07/14
Last modified on 2015/07/19 08:25:39

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Basic information

Public title

Osteoporosis screening using FRAX by community pharmacists and Collaborative pharmacotherapy in the osteoporotic treatment

Acronym

Osteoporosis screening using FRAX by community pharmacists and Collaborative pharmacotherapy in the osteoporotic treatment

Scientific Title

Osteoporosis screening using FRAX by community pharmacists and Collaborative pharmacotherapy in the osteoporotic treatment

Scientific Title:Acronym

Osteoporosis screening using FRAX by community pharmacists and Collaborative pharmacotherapy in the osteoporotic treatment

Region

Japan


Condition

Condition

Osteoporosis

Classification by specialty

Plastic surgery Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine the efficacy of pharmacist interventions in osteoporosis management

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. rate of osteoporosis screening follow-up exams
2. osteoporosis treatment adherence

Key secondary outcomes

1.risk of fracture
2.rate of pharmacotherapy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

pharmacist interventions in osteoporosis management by screening using FRAX

Interventions/Control_2

usual pharmaceutical care

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


Not applicable

Gender

Female

Key inclusion criteria

1 women over 50 years of age
2.patients whose content is obtained in written form

Key exclusion criteria

women currently on prescription osteoporosis medications

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kunizo Arai

Organization

Institute of Medical, Pharmaceutical, and Health Sciences. Kanazawa University

Division name

Faculty of Pharmacy

Zip code


Address

Kakuma-machi, Kanazawa

TEL

+81762646224

Email

arai@p.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kunizo Arai

Organization

Institute of Medical, Pharmaceutical, and Health Sciences. Kanazawa University

Division name

Faculty of Pharmacy

Zip code


Address

Kakuma-machi, Kanazawa

TEL

+81762646224

Homepage URL


Email

arai@p.kanazawa-u.ac.jp


Sponsor or person

Institute

Faculty of Pharmacy, Institute of Medical, Pharmaceutical, and Health Sciences, Kanazawa University, Clinical Drug Informatics

Institute

Department

Personal name



Funding Source

Organization

Kanazawa University

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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 07 Month 14 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

Open public recruiting

Date of protocol fixation

2015 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 14 Day

Last modified on

2015 Year 07 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021190


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name