UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036853 |
|---|---|
| Receipt number | R000041983 |
| Scientific Title | Examination about the effect of the efficacy and safety by the presence or absence of the combination of romosozumab and active vitamin D3 preparation |
| Date of disclosure of the study information | 2019/05/27 |
| Last modified on | 2019/05/26 10:41:09 |
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Basic information
Public title
Examination about the effect of the efficacy and safety by the presence or absence of the combination of romosozumab and active vitamin D3 preparation
Acronym
Examination about the effect of the efficacy and safety by the presence or absence of the combination of romosozumab and active vitamin D3 preparation
Scientific Title
Examination about the effect of the efficacy and safety by the presence or absence of the combination of romosozumab and active vitamin D3 preparation
Scientific Title:Acronym
Examination about the effect of the efficacy and safety by the presence or absence of the combination of romosozumab and active vitamin D3 preparation
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is for patients with osteoporosis, combined with romosozumab alone, in combination with 2 active vitamin D3 preparations romosozumab + eldecalcidol, romosozumab + alphacalcidol divided into 3 groups, combined with active vitamin D3 for romosozumab administration Verify the effectiveness and safety of
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone mineral density changes before and 6 months and 12monthsafter start of treatment
Key secondary outcomes
Occurrence of hypocalcemia
Other adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
romosozumab group
Interventions/Control_2
romosozumab + eldecalcidol group
Interventions/Control_3
romosozumab + alfacalcidol group
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
1:Osteoporosis patients who are more than 20 years old
2:Patients who agree with this study
Key exclusion criteria
1:Patients who are allergic to romosozumab or eldecalcidol or alfacalcidol
2:Pregnant or breast-feeding patients
3:Hypocalcemia
4:Patients with severe renal function (eGFR 30 ml / min / 1.73 m2) or patients undergoing dialysis
5:Patients at risk of hypercalcemia (patients with renal dysfunction, patients with malignancy, patients with primary hyperparathyroidism)
6:Patients with severe liver dysfunction
7:Patients with urolithiasis and patients with a history of their history
8:Others, patients judged by the research director as inappropriate
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Nakamura |
Organization
Shinshu University School of Medicine
Division name
Dept. of Orthopaedic Surgery
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto 3908621, Japan
TEL
0263372659
yxn14@aol.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Nakamura |
Organization
Shinshu University School of Medicine
Division name
Dept. of Orthopaedic Surgery
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto 3908621, Japan
TEL
0263372659
Homepage URL
yxn14@aol.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
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
Shinshu University School of Medicine Dept. of Orthopaedic Surgery
Address
Asahi 3-1-1, Matsumoto 3908621, Japan
Tel
0263372659
yxn14@aol.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
| 2019 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 26 | Day |
Last modified on
| 2019 | 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=R000041983
