UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019574 |
|---|---|
| Receipt number | R000021795 |
| Scientific Title | Effect of Denosumab and Alendronate on glucocorticoid-induced osteoporosis in patients with glomerulonephritis:a randomized controlled trial |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2017/04/28 12:14:49 |
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Basic information
Public title
Effect of Denosumab and Alendronate on glucocorticoid-induced osteoporosis in patients with glomerulonephritis:a randomized controlled trial
Acronym
Effect of Denosumab and Alendronate on glucocorticoid-induced osteoporosis in patients with glomerulonephritis:a randomized controlled trial
Scientific Title
Effect of Denosumab and Alendronate on glucocorticoid-induced osteoporosis in patients with glomerulonephritis:a randomized controlled trial
Scientific Title:Acronym
Effect of Denosumab and Alendronate on glucocorticoid-induced osteoporosis in patients with glomerulonephritis:a randomized controlled trial
Region
| Japan |
Condition
Condition
Glucocorticoid-Induced 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 glucocorticoidiunduced osteoporosis in patients with glomerulonephritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
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
Dynamic allocation
Institution consideration
Blocking
Concealment
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 (35 mg) by oral administration once a week
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 who meet the glucocorticoid- induced osteoporosis criteria
2) Patient whose age is more than 20 years old
Key exclusion criteria
1) 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 eGFR is less than 35ml/min/1.73m2.
7) Patients whose i-PTH is more than 300ml/min.
8) Patients whose corrected Ca is less than 8.4 mg/dL.
9) Patients who are thought to be inappropriate for this study by physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Iyoda |
Organization
Showa University School of Medicine
Division name
Division of Nephrology, Department of Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8533
iyoda@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Iseri |
Organization
Showa University School of Medicine
Division name
Division of Nephrology, Department of Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8533
Homepage URL
iseriken@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School 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
| 2015 | Year | 10 | Month | 30 | 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
| 2015 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 30 | 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
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2017 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021795
