UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037123 |
|---|---|
| Receipt number | R000042296 |
| Scientific Title | Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab |
| Date of disclosure of the study information | 2019/06/20 |
| Last modified on | 2019/06/19 23:02:41 |
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Basic information
Public title
Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab
Acronym
Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab
Scientific Title
Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab
Scientific Title:Acronym
Evaluation of the efficacy and safety of romosozumab alone and romosozumab + denosumab combination for patients with osteoporosis treated with 2-year denosumab
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the efficacy and safety of the two treatments of romosozumab alone and romosozumab plus denosumab after 2 years of treatment with osteoporosis for osteoporosis patients.
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 at 12 months after treatment
Key secondary outcomes
Occurrence of hypocalcemia
Occurrence of other adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
romosozumab plus active vitamin D group
Interventions/Control_2
romosozumab + denosumab plus active vitamin D 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1:All osteoporosis patients over 20 years old or older (but does not correspond to the following exclusion criteria)3
2: Patients who have already received Denosumab (60 mg once every 6 months) for 2 years before the start of the study and have a YAM value of 70% or more or a bone density value of less than -2.5 SD
3:Patients who agree with this study
Key exclusion criteria
1:Patients who have taken romosozumab or denosumab before
2:Patients who are allergic to romosozumab or denosumab or eldecalcitol
3:Hypocalcemia
4:Pregnant or breast-feeding patients
5:Patients with severe renal function (eGFR 30 ml / min / 1.73 m2) or patients undergoing dialysis
6:Patients at risk of hypercalcemia (patients with renal dysfunction, patients with malignancy, patients with primary hyperparathyroidism)
7:Patients with severe liver dysfunction
8:Patients with urolithiasis and patients with a history of their history
Target sample size
60
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 | 06 | Month | 20 | 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 | 06 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 03 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042296
