UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007742
Receipt number R000009123
Scientific Title Examination for the effect of combination therapy with raloxifene and eldecalcitol in primary osteoporotic patients -Switch from alfacalcidol to eldecalcitol-
Date of disclosure of the study information 2012/04/13
Last modified on 2012/05/09 10:56:47

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Basic information

Public title

Examination for the effect of combination therapy with raloxifene and eldecalcitol in primary osteoporotic patients -Switch from alfacalcidol to eldecalcitol-

Acronym

Effect of combination therapy with raloxifene and eldecalcitol for osteoporosis -Switch from alfacalcidol to eldecalcitol-

Scientific Title

Examination for the effect of combination therapy with raloxifene and eldecalcitol in primary osteoporotic patients -Switch from alfacalcidol to eldecalcitol-

Scientific Title:Acronym

Effect of combination therapy with raloxifene and eldecalcitol for osteoporosis -Switch from alfacalcidol to eldecalcitol-

Region

Japan


Condition

Condition

Osteoporosis

Classification by specialty

Endocrinology and Metabolism Geriatrics Obstetrics and Gynecology
Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the effect in primary osteoporotic patients undergoing combination therapy with raloxifene 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 of lumbar spine bone mineral density

Key secondary outcomes

Change of total hip bone mineral density
Number of fracture occurred
Change of bone metabolic markers
Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Raloxifene + alfacalcidol for 48 weeks

Interventions/Control_2

Raloxifene + eldecalcitol for 48 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1) Primary osteoporotic patients
2) Patients who are treated with raloxifene and alfacalcidol for more than 24 weeks
3) Patients with informed of consent

Key exclusion criteria

1) Patients who are diagnosed as contraindication of raloxifene treatments
2) Patients who are diagnosed as contraindication of eldecalcitol treatments
3) Patients who have serum calcium levels of above 10.5mg/dL
4) Patients who have taken osteoporosis treatments other than raloxifene and alfacalcidol
5) Patients who are inappropriate for this study by physician

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shoichi Ichimura

Organization

Kyorin University

Division name

Department of Orthopaedic Surgery

Zip code


Address

6-20-2 Shinkawa, Mitaka, Tokyo, Japan

TEL

0422-47-5511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masaichi Hasegawa

Organization

Kyorin University

Division name

Department of Orthopaedic Surgery

Zip code


Address

6-20-2 Shinkawa, Mitaka, Tokyo, Japan

TEL

0422-47-5511

Homepage URL


Email

hasemasa@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Kyorin University

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

Yamanashi Hospital of Social Insurance

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 04 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

Enrolling by invitation

Date of protocol fixation

2012 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2012 Year 04 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

2012 Year 04 Month 13 Day

Last modified on

2012 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009123


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name