UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027182 |
|---|---|
| Receipt number | R000031144 |
| Scientific Title | Evaluation of the elimination of Alendronate in hemodialysis patients |
| Date of disclosure of the study information | 2017/05/15 |
| Last modified on | 2018/03/09 16:37:09 |
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Basic information
Public title
Evaluation of the elimination of Alendronate in hemodialysis patients
Acronym
Evaluation of the elimination of Alendronate in hemodialysis patients
Scientific Title
Evaluation of the elimination of Alendronate in hemodialysis patients
Scientific Title:Acronym
Evaluation of the elimination of Alendronate in hemodialysis patients
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the elimination of alendronate by hemodialysis after intravenous administration of 900 ug alendronate.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the elimination of alendronate calculated by the difference of concentration between the arterial line and the venous line.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients whose age is not less than 20 years old
2) general condition is good
3) Patients who have maintained dialysis therapy for over 3 months
4) Patients who have already diagnosed osteoporosis and treated with alendronate
5) the investigator judge the patients to be appropriate to participate in the study
Key exclusion criteria
1) Patients with severe liver disease
2) Patients with severe heart disease
3) Patients may be pregnant
4)Patients with active infections
5) Patients who have bad oral consitions
6) Patients who are thought to be inappropriate for this study by physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Watanabe |
Organization
Makita general hospital
Division name
Internal medicine
Zip code
Address
1-34-6 Omorikita, Ohta-ku, Tokyo
TEL
03-3762-4671
makotonb@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Iseri |
Organization
Makita general hospital
Division name
Internal medicine
Zip code
Address
1-34-6 Omorikita, Ohta-ku, Tokyo
TEL
03-3762-4671
Homepage URL
iseriken@med.showa-u.ac.jp
Sponsor or person
Institute
Makita general hospital
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | 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
observational study
Management information
Registered date
| 2017 | Year | 04 | Month | 28 | Day |
Last modified on
| 2018 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031144
