UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001993
Receipt number R000002430
Scientific Title Effects of rosuvastatin and ezetimibe on bone turnover markers in type 2 diabetes patients with hypercholesterolemia
Date of disclosure of the study information 2009/05/21
Last modified on 2009/06/29 03:26:43

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Basic information

Public title

Effects of rosuvastatin and ezetimibe on bone turnover markers in type 2 diabetes patients with hypercholesterolemia

Acronym

Effects of rosuvastatin and ezetimibe on bone turnover markers

Scientific Title

Effects of rosuvastatin and ezetimibe on bone turnover markers in type 2 diabetes patients with hypercholesterolemia

Scientific Title:Acronym

Effects of rosuvastatin and ezetimibe on bone turnover markers

Region

Japan


Condition

Condition

hypercholesterolemia with type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effects of rosuvastatin and ezetimibe on bone turnover markers

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bone turnover markers

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

Rosuvastatin

Interventions/Control_2

Ezetimibe

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with newly diagnosed hypercholesterolemia, who visited our out clinic for education, evaluation, or treatment of type 2 diabetes, were enrolled if informed consent was obtained after a detailed explanation of the study purpose and methods.

Key exclusion criteria

Nobody had hepatic or renal dysfunction or nutritional derangements. All patients were free of drugs known to influence bone and calcium metabolism, such as vitamin D, bisphosphonate, or estrogen, up until the time of the study. Nobody had treatments with any cholesterol lowering agent.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ippei Kanazawa

Organization

Shimane University School of Medicine

Division name

Internal Medicine 1

Zip code


Address

89-1 Enya-cho, Izumo, Shimane

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Shimane University School of Medicine

Division name

Internal Medicine 1

Zip code


Address


TEL


Homepage URL


Email

ippei.k@med.shimane-u.ac.jp


Sponsor or person

Institute

Department of Internal Medicine 1, Shimane University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Internal Medicine 1, Shimane University School of Medicine

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 05 Month 21 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

Serum osteocalcin levels in the rosuvastatin group were significantly increased, while any bone marker in the ezetimibe group was not changed.

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

2008 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 12 Month 01 Day

Last follow-up date

2009 Year 06 Month 01 Day

Date of closure to data entry

2009 Year 06 Month 01 Day

Date trial data considered complete

2009 Year 06 Month 01 Day

Date analysis concluded

2009 Year 06 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 05 Month 21 Day

Last modified on

2009 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002430


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name