UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	In DIAlysis patient study of efficacy and safety of MONthly minoDoronate
Title of the study (Brief title)	DIAMOND study
Region	Japan

Condition
Condition	osteoporosis in dialysis patients
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the safety and efficacy of monthly minoDoronate treatment for osteoporosis with dialysis patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of bone mineral density and safty of minodoronate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	adminstrate minedonorate 50mg monthly for 52 weeks
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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients receving hemodialysis including these criteria 1)osteoprotic patients 2)Age-lower limit:18 years old, age-higher limit:85 years old 3)Patients with informed of consent 4)i-PTH:60-240
Key exclusion criteria	1)Patients who have obstacles which delays esophagus passage of stricture of the esophagus or achalasia 2)Patients who have raised the upper part of the body for 30 minutes or it cannot be standing 3)hypersensitivity for bisphosphonate 4)The patient with hypocalcemia 5)Patients in or expecting pregnancy 6)Patients who diagnosed malignancy 7)Patients receiving specific treatments that affect bone and mineral metabolism such as recombinant human PTH, and Eldecalcitol 8)Patients who took SERM within a month before this trial 9)Patients who took bisphophonate within 6 month before this trial 10)Patients who are inappropriate for this study by physician
Target sample size	50

Research contact person
Name of lead principal investigator	Tadashi Tomo
Organization	Oita university facility of medicine
Division name	internal medicine2
Address	1-1 idaigaoka hasama-machi yufu-shi oita-ken
TEL	097-586-5138
Email	tomo@oita-u.ac.jp

Public contact
Name of contact person	Takeshi Nakata
Organization	Oita university facility of medicine
Division name	internal medicine 2
Address	1-1 idaigaoka hasama-machi yufu-shi oita-ken
TEL	097-586-5138
Homepage URL
Email	tomo@oita-u.ac.jp

Sponsor
Institute	Oita university facility of medicine
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)

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	2013 Year 03 Month 10 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 08 Month 15 Day
Anticipated trial start date	2012 Year 09 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

Management information
Registered date	2013 Year 03 Month 07 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011865