UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010185 |
|---|---|
| Receipt number | R000011865 |
| Scientific Title | In DIAlysis patient study of efficacy and safety of MONthly minoDoronate |
| Date of disclosure of the study information | 2013/03/10 |
| Last modified on | 2018/09/10 18:41:02 |
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Basic information
Public title
In DIAlysis patient study of efficacy and safety of MONthly minoDoronate
Acronym
DIAMOND study
Scientific Title
In DIAlysis patient study of efficacy and safety of MONthly minoDoronate
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tadashi Tomo |
Organization
Oita university facility of medicine
Division name
internal medicine2
Zip code
Address
1-1 idaigaoka hasama-machi yufu-shi oita-ken
TEL
097-586-5138
tomo@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakata |
Organization
Oita university facility of medicine
Division name
internal medicine 2
Zip code
Address
1-1 idaigaoka hasama-machi yufu-shi oita-ken
TEL
097-586-5138
Homepage URL
tomo@oita-u.ac.jp
Sponsor or person
Institute
Oita university facility of medicine
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 10 | 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 | 08 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011865
