UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025056 |
|---|---|
| Receipt number | R000028286 |
| Scientific Title | The effect of denosmab on osteoporosis related to Parkinson's disease and glucocorticoid-induced osteoporosis |
| Date of disclosure of the study information | 2016/11/29 |
| Last modified on | 2020/09/05 16:06:58 |
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Basic information
Public title
The effect of denosmab on osteoporosis related to Parkinson's disease and glucocorticoid-induced osteoporosis
Acronym
The effect of denosmab on neurological disorders
Scientific Title
The effect of denosmab on osteoporosis related to Parkinson's disease and glucocorticoid-induced osteoporosis
Scientific Title:Acronym
The effect of denosmab on neurological disorders
Region
| Japan |
Condition
Condition
osteoporosis, Parkinson's disease
neuroimmunological disease
Classification by specialty
| Neurology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effectiveness of denosmab on BMD, bone turnover markers and bone quality-related markers in glucocorticoid-induced osteoporosis and osteoporosis related to Parkinson's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Change in BMD
-Change in bone turnover markers
-Change in bone quality-related markers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
denosmab
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)>= 40 to =< 85 years of age at the time of consent
(2)Patients with osteoporosis related to Parkinson's disease
(3)Patients with glucocorticoid-induced osteoporosis
Key exclusion criteria
(1)Current or previous use of denosumab
(2)Patients with renal insufficiency (CCr <30ml/min)
(3)Patients with hypocalcemia(serum calcium<8.4mg/dl)
(4)Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shusaku Omoto |
Organization
The Jikei University School of Medicine
Division name
Department of Neurology
Zip code
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
s-omoto@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shusaku Omoto |
Organization
The Jikei University School of Medicine
Division name
Department of Neurology
Zip code
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
s-omoto@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2016 | Year | 11 | Month | 29 | 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 | 10 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2020 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028286
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| Registered date | File name |
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| Registered date | File name |
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