UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011461 |
|---|---|
| Receipt number | R000013241 |
| Scientific Title | An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis |
| Date of disclosure of the study information | 2013/08/12 |
| Last modified on | 2018/02/14 11:06:14 |
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Basic information
Public title
An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis
Acronym
OSRANKLE-SIO study
Scientific Title
An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis
Scientific Title:Acronym
OSRANKLE-SIO study
Region
| Japan |
Condition
Condition
steroid induced osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Neurology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the the efficacy and safety of anti-RANKL monoclonal antibody (Denosumab) for steroid induced osteoporosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in bone mineral density of lumber spine
In case of spinal bone osteo-sclerosis or spinal bone fracture, femoral neck or distal 2th finger will be substituted
Incidence rate of pathological bone fracture
Fracture was validated by x-ray and/or MRI scan
Key secondary outcomes
Change in bone metabolism markers NTX(serum , urine), bone-type alkaline phosphatase, Magnesium, Calcium, phosphorus, intact PTH, calcitonin
Correlation between bone mineral density and activated vitamin D blood concentration levels
Numerical rating score will be measured for pain
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients will be subcutaneous injected subcutaneously with 60 mg of denosumab every 6 months for 12 months.
All subjects will be treated with daily pills containing calcium, naive Vitamin D, with magnesium supplementation. Activated form of vitamin D will be introduced for patients with impaired renal function of serum creatinine value of 2 or more.
Interventions/Control_2
Discontinue the administration of aredoron acid, risedronate, of minodronic acid.
All subjects will be received daily pills containing calcium and naive vitamin D, and magnesium supplementation.
Activated forms of vitamin D will be introduced for patients with impaired renal function of serum creatinine value of 2 or more.
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
Plan to use or administration of oral steroid for more than 3 months
With written informed consent
Key exclusion criteria
1)Cancer patients with bone metastasis or expected bone metastasis
2)Hypocalcemia
3)Women who wish to be pregnant or are pregnant, or in lactation
4)Hypersensitivity to the denosumab
5)Cancer patients on cancer treatment or anti-hormonal therapy
6)Dental therapy during this trial
7)Long term use of bisphosphonate and have atypical fracture
8)Severe skin infection
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobutaka Hattori |
Organization
Juntendo University School of Medicine
Division name
Neurology
Zip code
Address
2-1-1 Hongo bunkyo Tokyo 113-8421Japan
TEL
03-3813-3111
kazumasa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumasa Yokoyama |
Organization
Juntendo University School of Medicine
Division name
Neurology
Zip code
Address
2-1-1 Hongo bunkyo Tokyo 113-8421 Japan
TEL
03-3813-3111
Homepage URL
kazumasa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
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
self
Name of secondary funder(s)
None
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
順天堂大学附属順天堂医院（東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 12 | 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
| 2013 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 12 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013241
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