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
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
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
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
