UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033122 |
|---|---|
| Receipt number | R000037754 |
| Scientific Title | Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis |
| Date of disclosure of the study information | 2018/06/23 |
| Last modified on | 2019/12/24 09:51:17 |
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Basic information
Public title
Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Acronym
Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Scientific Title
Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Scientific Title:Acronym
Denosumab and Alendronate, Examination of the effective of Glucocorticoid-induced Osteoporosis
Region
| Japan |
Condition
Condition
Steroid induced osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we examine the noninferiority of denosumab as compared with alendronate, which is regarded as the first-line drug in guidelines for treatment and management of steroid osteoporosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endopoint is the bone density change after 6 months and 1 year at administration.
Key secondary outcomes
Secondary endpoints are the change of bone metabolism markers during the observation period, morphological vertebral fractures and clinical fractures of the observation period, change of the lumbar TBS and adverse events.
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
the denosumab subcutaneous injection 6 months once treatment group
Interventions/Control_2
the the Alendronate oral weekly treatment group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who satisfy all of the following criteria are included in this study.
1)Patients over 18 years old, male and female unquestioned
2)Guidelines for management and treatment of steroid osteoporosis: Patients with a score of 3 or more with the 2014 algorithm
Key exclusion criteria
Patients falling under any of the following are excluded from this research.
1)Patients who may be pregnant or pregnant, patients who desire pregnancy
2)Patients already taking steroids
3)Patients receiving donosumab or bisphosphonate
4)Patient with a disorder delaying esophageal passage such as esophageal stenosis or achalasia (esophageal relaxation disorder)
5)Patients who are raising their upper body for more than 30 minutes or who can not stand
6)Patients with a history of hypersensitivity to denosumab and alendronate or other bisphosphonates.
7)Patients with hypocalcemia
8)Patients judged inappropriate as subjects by the attending physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Okada |
Organization
University of Occupational and Environmental Health, Japan, School of Medicine
Division name
The First Department of Internal Medicine
Zip code
8078555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL
093-603-1611
y-okada@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Torimoto |
Organization
University of Occupational and Environmental Health, Japan, School of Medicine
Division name
The First Department of Internal Medicine
Zip code
8078555
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL
093-603-1611
Homepage URL
torimoto@med.uoeh-u.ac.jp
Sponsor or person
Institute
The First Department of Internal Medicine
University of Occupational and Environmental Health, Japan, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The First Department of Internal Medicine
University of Occupational and Environmental Health, Japan, 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
University of Occupational and Environmental Health, Japan, School of Medicine
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
Tel
093-603-1611
sunday@pub.uoeh-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
| 2018 | Year | 06 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037754
