UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004188
Receipt number R000005030
Scientific Title A prospective, randomized controlled trial comparing alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias
Date of disclosure of the study information 2010/09/10
Last modified on 2014/09/10 12:46:12

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Basic information

Public title

A prospective, randomized controlled trial comparing alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias

Acronym

Steroid-induced osteoporosis accompanied with interstitial pneumonias

Scientific Title

A prospective, randomized controlled trial comparing alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias

Scientific Title:Acronym

Steroid-induced osteoporosis accompanied with interstitial pneumonias

Region

Japan


Condition

Condition

interstitial pneumonias

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects and the safety of alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1) The change in the lumbar-spine bone mineral density from baseline
(2) The change in the markers of of bone metabolism from baseline

Key secondary outcomes



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

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

alendronate

Interventions/Control_2

alendronate plus alphacalcidol

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients who was expected to treat with oral prednisolone 30mg/day at least for a week and continued with 5mg/day of prednisolone at least for three months for the therapy of interstitial pneumonias

Key exclusion criteria

(1) The patients who have severe complications
(2) The patients who have the diseases of bone metabolism
(3) The patients who were administered steroid therapy within a year
(4) The patients who are administered therapy affecting bone metabolism
(5) The patients who have fracture or scoliosis at 3rd to 5th lumbar
(6) The patients who have impaired renal function (Cr > 1.5mg/dl)
(7) The patients who are contraindicated to take alendronate or alphacalcidol
(8) The patients who are pregnant
(9) The patients who attended clinical trials within three months

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeru Kohno

Organization

Nagasaki University School of Medicine

Division name

Second Department of Internal Medicine

Zip code


Address

1-7-1 Sakamoto, Nagasaki, Japan

TEL

095-819-7273

Email

nsakamot@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriho Sakamoto

Organization

Nagasaki University Hospital

Division name

Second Department of Internal Medicine

Zip code


Address

1-7-1 Sakamoto, Nagasaki, Japan

TEL

095-819-7273

Homepage URL


Email

nsakamot@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University School of Medicine

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

2010 Year 09 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

No longer recruiting

Date of protocol fixation

2008 Year 01 Month 17 Day

Date of IRB


Anticipated trial start date

2008 Year 01 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

2010 Year 09 Month 10 Day

Last modified on

2014 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name