UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001628
Receipt number R000001957
Scientific Title Improvements in persistence and compliance with various bisphosphonates with long-term patient education using FRAX
Date of disclosure of the study information 2009/01/13
Last modified on 2017/01/16 16:10:04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Improvements in persistence and compliance with various bisphosphonates with long-term patient education using FRAX

Acronym

IMPROVABLE trial

Scientific Title

Improvements in persistence and compliance with various bisphosphonates with long-term patient education using FRAX

Scientific Title:Acronym

IMPROVABLE trial

Region

Japan


Condition

Condition

osteoporosis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine if long-term patient education using FRAX can improve the persistence and compliance with bisphosphonate therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

persistence with bisphosphonate therapy

Key secondary outcomes

compliance with bisphosphonate therapy
change in bone mineral density


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Patients with osteoporosis who are going to receive bisphosphonates are randomly assigned to 2 study groups. Group A receive patient education with information about 10-year fracture probability using FRAX.

Interventions/Control_2

group B followed current practice.

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients aged 40 years or older, with a prior or new diagnosis of osteoporosis and receiving treatment with bisphosphonates.

Key exclusion criteria

patients who are inappropriate to receive bisphosphonates

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeru Ohno

Organization

Yokohama City University Medical Center

Division name

Center for rheumatic diseases

Zip code


Address

4-57 Urafune-cho Minami-ku, Yokohama, Japan

TEL

0452615656

Email

ohno@urahp.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shigeru Ohno

Organization

Yokohama City University Medical Center

Division name

Center for rheumatic diseases

Zip code


Address

4-57 Urafune-cho minami-ku Yokohama

TEL

045-261-5656

Homepage URL


Email

ohno@urahp.yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Medical Center, Center for rheumatic diseases

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


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

2009 Year 01 Month 13 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

No longer recruiting

Date of protocol fixation

2008 Year 12 Month 26 Day

Date of IRB


Anticipated trial start date

2009 Year 01 Month 01 Day

Last follow-up date

2014 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 01 Month 09 Day

Last modified on

2017 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001957


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name