UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040533 |
|---|---|
| Receipt number | R000046269 |
| Scientific Title | Efficacy of denosumab in steroid-induced osteoporosis against insufficient effect by bisphosphonate. |
| Date of disclosure of the study information | 2020/05/26 |
| Last modified on | 2020/05/26 21:43:35 |
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Basic information
Public title
Efficacy of denosumab in steroid-induced osteoporosis against insufficient effect by bisphosphonate.
Acronym
Efficacy of denosumab in steroid-induced osteoporosis against insufficient effect by bisphosphonate.
Scientific Title
Efficacy of denosumab in steroid-induced osteoporosis against insufficient effect by bisphosphonate.
Scientific Title:Acronym
Efficacy of denosumab in steroid-induced osteoporosis against insufficient effect by bisphosphonate.
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although it is reccomended by bisphosphonate against treatment of steroid-induced osteoporosis, there is insufficient case treated by bisphosphonate. We administered denosumab to patients with steroid-induced osteoporosis against insufficient effect by bisphosphonate, and the efficacy of denosumab were prospectively investigated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in bone mineral density (BMD) and bone turnover markers were investigated at 24 and 52 weeks.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Steroid induced osteoporosis uncontrolled bisphosphonate
Key exclusion criteria
Can not use denosumab
Can not agree this trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Kitamura |
Organization
Nihon University School of Medicine
Division name
Division of Hematology and Rheumatology, Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kamichi Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
kitamura.noboru@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Npbpru |
| Middle name | |
| Last name | Kitamura |
Organization
Nihon University School of Medicine
Division name
Division of Hematology and Rheumatology Department of Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kamichi Itabashi-ku Tokyo Japan
TEL
03-3972-8111
Homepage URL
kitamura.noboru@nihon-u.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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
Nihon University School of Medicine
Address
30-1 Oyaguchi Kamichi Itabashi-ku, Tokyo, Japan
Tel
03-3972-8111
kitamura.noboru@nihon-u.ac.jp
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
| 2020 | Year | 05 | Month | 26 | 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
50
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
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No describe
Management information
Registered date
| 2020 | Year | 05 | Month | 26 | Day |
Last modified on
| 2020 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046269
