UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022985 |
|---|---|
| Receipt number | R000026492 |
| Scientific Title | Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial |
| Date of disclosure of the study information | 2016/07/10 |
| Last modified on | 2018/04/10 11:02:37 |
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Basic information
Public title
Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Acronym
Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Scientific Title
Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Scientific Title:Acronym
Effect of Denosumab and Alendronate on osteoporosis in hemodialysis patients :a randomized controlled trial
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of denosumab and alendronate on osteoporosis in hemodialysis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change of bone mineral density (BMD) in lumber spine, femoral neck and distal radius at 6, 12 month after intervention
Key secondary outcomes
Percent change of bone metabolism markers, rate of continuation, side effect at 6, 12 month after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
denosumab (60 mg) subcutaneously every
6 months
Interventions/Control_2
Alendronate (900 maicrog) by Intravenous administration every 4 weeks
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) Hemodialysis patient whose age is not less than 20 years old
2) A written informed consent is obtained.
3) Patients whose T-score is not greater than -2.5 or YAM is less than 70%.
Patients with an existing insufficiency whose YAM is less than 80%.
4) Patients who have maintained dialysis therapy for over 6 months
5) Patients whose i-PTH is 60-240.
Key exclusion criteria
) Patients who are considered to be contraindicated for denosumab.
2) Patients who are considered to be contraindicated for alendronate.
3) Cancer patients.
4) Patients who have pretreated with bisphosphonate in recent 6 months.
5) Patients who have pretreated with denosumab in recent 6 months.
6) Patients whose corrected Ca is less than 8.4 mg/dL.
7) Patients with severe liver disease
8) Patients with severe heart disease
9) Patients may be pregnant
10) Patients who have bad oral consitions
11) Patients who are thought to be inappropriate for this study by physician.
Target sample size
80
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
The Kidney Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Haneda oozora Clinic
Adachimotoki jin Clinic
Heiwa Hospital
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
| 2016 | Year | 07 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 10 | 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
| 2016 | Year | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026492
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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