UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008116
Receipt number R000009553
Scientific Title A study on bone metabolism in patients with long-term use of anti-epileptic drugs
Date of disclosure of the study information 2012/08/01
Last modified on 2014/06/06 09:10:46

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Basic information

Public title

A study on bone metabolism in patients with long-term use of anti-epileptic drugs

Acronym

Bone metabolism in patients with epilepsy

Scientific Title

A study on bone metabolism in patients with long-term use of anti-epileptic drugs

Scientific Title:Acronym

Bone metabolism in patients with epilepsy

Region

Japan


Condition

Condition

epilepsy

Classification by specialty

Medicine in general Endocrinology and Metabolism Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Long-term use of anti-epileptic drugs is a cause of abnormal bone metabolism. This study is aimed to survey bone mineral density in Japanese adults with epilepsy and to assess the increased risk of osteomalacia by anti-epileptic drugs.

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

bone mineral density

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with epilepsy who administrate anti-epileptic drugs

Key exclusion criteria

1. Patients with chronic renal failure
2. Patients treated with steroids
3. Patients with malabsorption of calcium and/or vitamin D

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Kuga

Organization

Kobe University Hospital

Division name

Division of Neurology

Zip code


Address

7-5-1, Kusunoki-chou, Chuo-ku, Kobe 650-0017, Japan

TEL

+81-78-382-5885

Email



Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Kuga

Organization

Kobe University Hospital

Division name

Division of Neurology

Zip code


Address

7-5-1, Kusunoki-chou, Chuo-ku, Kobe 650-0017, Japan

TEL

+81-78-382-5885

Homepage URL


Email



Sponsor or person

Institute

Division of Neurology, Kobe University 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


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

神戸大学病院(兵庫県)、県立尼崎病院(兵庫県)、市立加西病院(兵庫県)、社会保険中央病院(兵庫県)、小野市民病院(兵庫県)、愛仁会高槻病院(大阪府)


Other administrative information

Date of disclosure of the study information

2012 Year 08 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

No longer recruiting

Date of protocol fixation

2012 Year 06 Month 11 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2013 Year 03 Month 01 Day

Date analysis concluded



Other

Other related information

In this study, a set of clinical data as shown below are analysed.

1. Bone mineral density
2. Clinical marker in serum
Albumin, creatinine,calcium,
phosphate,TSH,intact-PTH, 1,25OH2-
VitaminD,NTX,BAP,25OH-VitaminD,
TRACP-5b,carboxyl-osteocalcin
3. Clinical marker in urine
creatinine, calcium, phpsphate, NTX


Management information

Registered date

2012 Year 06 Month 06 Day

Last modified on

2014 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009553


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name