UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036854 |
|---|---|
| Receipt number | R000041985 |
| Scientific Title | Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide |
| Date of disclosure of the study information | 2019/05/27 |
| Last modified on | 2019/05/26 10:42:18 |
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Basic information
Public title
Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide
Acronym
Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide
Scientific Title
Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide
Scientific Title:Acronym
Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of efficacy and safety treated by Teriparatide less than 6 months administration, romosozumab 12 months administration group, teriparatide 6 months or more but less than 12 months administration, romosozumab 12 months administration group, teriparatide 12 months or more after 24 months administration, romosozumab 12 months administration group in osteoporosis
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 change up to 12 months before and every 6 months after treatment start
Key secondary outcomes
Occurrence of hypocalcemia
Occurrence of other adverse events
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
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teriparatide less than 6 months, lomosozumab 12 months group
Interventions/Control_2
Teriparatide 6 months or more and less than 12 months group
Interventions/Control_3
Teriparatide 12 to 24 months administration group 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:All osteoporosis patients over 20 years old or older (but does not correspond to the following exclusion criteria)
2:Patients who agree with this study
Key exclusion criteria
1:Patients who are allergic to romosozumab or teriparatide or eldecalcidol
2:Pregnant or breast-feeding patients
3:Patients considered to be at high risk of developing osteosarcoma
4:Patients with primary malignant or metastatic bone tumors
5:Patients with metabolic bone disease other than osteoporosis
6:Patients with unexplained high ALP
7:Others, patients judged by the research director as inappropriate
8:Hypocalcemia (serum corrected calcium level less than 8.0mg/dL)
9:Severe renal failure (less than eGFR15)
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 | 13 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 25 | 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=R000041985
