UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019642 |
|---|---|
| Receipt number | R000022700 |
| Scientific Title | Effects of alendronate and denosumab on glucocorticoid-induced osteoporosis by a randomized, open-labeled study |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2017/10/11 19:59:50 |
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Basic information
Public title
Effects of alendronate and denosumab on glucocorticoid-induced osteoporosis by a randomized, open-labeled study
Acronym
Effects of alendronate and denosumab on glucocorticoid-induced osteoporosis by a randomized, open-labeled study
Scientific Title
Effects of alendronate and denosumab on glucocorticoid-induced osteoporosis by a randomized, open-labeled study
Scientific Title:Acronym
Effects of alendronate and denosumab on glucocorticoid-induced osteoporosis by a randomized, open-labeled study
Region
| Japan |
Condition
Condition
Glucocorticoid-induced osteoporosis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare with safety and efficacy of denosumab and alendronate on glucocorticoid-induced osteoporosis by a randomized, open-labeled study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percent change in bone mineral density of the lumber spine and femoral neck
Key secondary outcomes
Incident vertebral fracture and non-vertebral fracture
safety
bone makers
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
alendronate 35mg/week +alfacalcidol 0.5ug/day.
It continues as glucocorticoid-induced osteoporosis treatment.
Interventions/Control_2
denosumab 60mg/6months +alfacalcidol 0.5ug/day.
It continues as glucocorticoid-induced osteoporosis treatment.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Guideline on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society (2014) with adaptation patients.
Key exclusion criteria
Medicine associated with the bone metabolism
Pregnancy
Abnormality of the serum calcium
Less than 30ml/min/1.73m2 of the eGFR
Severe complications such as liver, heart, renal disease
Hypersentivity
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Morita |
Organization
Gifu University Graduate School of Medicine
Division name
General Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
81-58-230-6632
hmorita@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahide Ikeda |
Organization
Gifu University Graduate School of Medicine
Division name
General Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6632
Homepage URL
tacahide@nifty.com
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine
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 | 11 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 06 | 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 | 11 | Month | 05 | Day |
Last modified on
| 2017 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022700
