UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the elimination of Alendronate in hemodialysis patients
Title of the study (Brief title)	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	Makoto Watanabe
Organization	Makita general hospital
Division name	Internal medicine
Address	1-34-6 Omorikita, Ohta-ku, Tokyo
TEL	03-3762-4671
Email	makotonb@med.showa-u.ac.jp

Public contact
Name of contact person	Ken Iseri
Organization	Makita general hospital
Division name	Internal medicine
Address	1-34-6 Omorikita, Ohta-ku, Tokyo
TEL	03-3762-4671
Homepage URL
Email	iseriken@med.showa-u.ac.jp

Sponsor
Institute	Makita general hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031144