UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009588
Receipt number R000011251
Scientific Title The effect of combination therapy with Alendronate and Eldecalcitol for glucocorticoid induced osteoporosis -switch from Alfacalcidol to Eldecalcitol-
Date of disclosure of the study information 2012/12/20
Last modified on 2014/06/23 13:43:39

* 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

The effect of combination therapy with Alendronate and Eldecalcitol for glucocorticoid induced osteoporosis -switch from Alfacalcidol to Eldecalcitol-

Acronym

The effect of combination therapy with Alendronate and Eldecalcitol for glucocorticoid induced osteoporosis -switch from Alfacalcidol to Eldecalcitol-

Scientific Title

The effect of combination therapy with Alendronate and Eldecalcitol for glucocorticoid induced osteoporosis -switch from Alfacalcidol to Eldecalcitol-

Scientific Title:Acronym

The effect of combination therapy with Alendronate and Eldecalcitol for glucocorticoid induced osteoporosis -switch from Alfacalcidol to Eldecalcitol-

Region

Japan


Condition

Condition

glucocorticoid induced osteoporosis

Classification by specialty

Endocrinology and Metabolism Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy and safety in glucocorticoid induced osteoporosis patients undergoing combination therapy with Alendronate and Alfacalcidol by switching from Alfacalcidol to Eldecalcitol

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change from baseline to 12 months in lumbar spine BMD

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

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

Treatment

Type of intervention

Medicine

Interventions/Control_1

Alendronate(35mg/week)+ Alfacalcidol(1.0mcg/day)

Interventions/Control_2

Alendronate (35mg/week) + Eldecalcitol (0.75mcg/day)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Glucocorticoid induced osteoporosis patients who have taken Alendronate and Alfacalcidol for more than 1 year and half year, respectively.
2. Patients with informed of consent.

Key exclusion criteria

1. Patients with contraindication for Eldecalcitol treatments
2. Patients who are inappropriate for this study by physicians.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsuji Goh

Organization

Shinko Hospital

Division name

Department of Rheumatic Disease

Zip code


Address

Wakinohamacho,1-4-47, Chuo-ku, Kobe, Hyogo

TEL

078-261-6711

Email

tsuji_goh@shinkohp.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Goh Tsuji

Organization

Shinko Hospital

Division name

Department of Rheumatic Disease

Zip code


Address

Wakinohamacho,1-4-47, Chuo-ku, Kobe, Hyogo

TEL

078-261-6711

Homepage URL


Email

tsuji_goh@shinkohp.or.jp


Sponsor or person

Institute

Department of Rheumatic Disease, Shinko Hospital

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

Shimane University Faculty of Medicine
DS Pharma Biomedical Co,Ltd.

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

2012 Year 12 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2012 Year 09 Month 20 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 16 Day

Last follow-up date

2014 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 12 Month 20 Day

Last modified on

2014 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011251


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name