UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001082
Receipt number R000001313
Scientific Title A randomized open-label blinded prospective study designed to compare the efficacy and safety between once-weekly and daily administration of alendronate in patients with corticosteroid-induced osteoporosis
Date of disclosure of the study information 2008/04/01
Last modified on 2011/09/23 08:20:15

* 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

A randomized open-label blinded prospective study designed to compare the efficacy and safety between once-weekly and daily administration of alendronate in patients with corticosteroid-induced osteoporosis

Acronym

A randomized prospective study to compare the efficacy and safety between once-weekly and daily alendronate therapy in patients with corticosteroid-induced osteoporosis

Scientific Title

A randomized open-label blinded prospective study designed to compare the efficacy and safety between once-weekly and daily administration of alendronate in patients with corticosteroid-induced osteoporosis

Scientific Title:Acronym

A randomized prospective study to compare the efficacy and safety between once-weekly and daily alendronate therapy in patients with corticosteroid-induced osteoporosis

Region

Japan


Condition

Condition

Corticosteroid-induced osteoporosis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

safety/ efficacy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Mean percent change in bone mineral density (BMD) of lumbar spine at 48 weeks

Key secondary outcomes

Mean percent change in BMD of lumbar spine at 24 weeks
Mean percent change in BMD of femur trochanter and distal radius at 24 and 48 weeks


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Once-weekly group: receive 35mg of alendronate once a week for 52 weeks

Interventions/Control_2

Daily group: receive 5mg of alendronate daily for 52 weeks

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are seeing in out patient clinic or hospitalized in Keio University Hospital. Patients who take more than 5 mg daily dose of prednisolone.Patients who can understand the aim of this study and consent to participate in this study.

Key exclusion criteria

Patients who take other medicine affected with bone metabolism (other bisphosphonates, calcitonin, vitamin D derivatives, ipriflavone, estrogen derivatives, menaquinones, Raloxifene hydrochloride) within twelve weeks.Patients who have allergic reaction to bisphosphonates.Patients who have esophageal stenosis or akalasia. Patients who cannot keep a sitting position more than 30 minutes.Patients who have sever renal, liver, cardiac dysfunction or hematological disorders. Patients who have metabolic disorders.Patients who have neoplasm.Patients who have hypocarcemia or hypercarcemia.Patients who are pregnant.Patients who are considered to inappropriate to join to this study.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Sato

Organization

Keio University School of Medicine

Division name

Internal Medicine

Zip code


Address

35 Shinanomachi Shinjuku-ku Tokyo

TEL

03-3353-1211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinji Sato

Organization

Keio University School of Medicine

Division name

Internal Medicine

Zip code


Address

35 Shinanomachi Shinjuku-ku Tokyo

TEL

03-3353-1211

Homepage URL


Email



Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

Teijin Pharmaceuticals

Organization

Division

Category of Funding Organization

Profit 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

2008 Year 04 Month 01 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

2008 Year 03 Month 10 Day

Date of IRB


Anticipated trial start date

2008 Year 03 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 04 Month 01 Day

Date trial data considered complete

2011 Year 06 Month 01 Day

Date analysis concluded

2011 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 03 Month 18 Day

Last modified on

2011 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001313


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name