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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008116
Receipt No. 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

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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
Institute Division of Neurology, Kobe University Hospital
Institute
Department

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
URL(English) https://upload.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


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