UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040132 |
|---|---|
| Receipt number | R000045760 |
| Scientific Title | Effect of subsequence treatment after romosozumab in patietns with osteoporosis: open-label, randomised contorlled trial |
| Date of disclosure of the study information | 2020/04/11 |
| Last modified on | 2023/11/26 08:52:04 |
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Basic information
Public title
Effect of subsequence treatment after romosozumab in patietns with osteoporosis: open-label, randomised contorlled trial
Acronym
Effect of subsequence treatment after romosozumab in patietns with osteoporosis: open-label, randomised contorlled trial
Scientific Title
Effect of subsequence treatment after romosozumab in patietns with osteoporosis: open-label, randomised contorlled trial
Scientific Title:Acronym
Effect of subsequence treatment after romosozumab in patietns with osteoporosis: open-label, randomised contorlled trial
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Geriatrics | 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 three treatments (Bisphosphonate, denosumab, teriparatide) following romosozumab in patients with osteoporosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density
Key secondary outcomes
Bone strength, Bone turnover markers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bisphosphonate group
Interventions/Control_2
Denosumab group
Interventions/Control_3
Teriparatide 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
Patients who finished 12 months of romosozumab treatment and plan to subsequence treatment. Written informed consent is needed to participate this study.
Key exclusion criteria
1.Those who have history of cancer.
2.Patients with severe renal dysfunction or those receiving dialysis
3. Those who have hypocalcemia
4.Patients who is going to have an operation.
5.Patients who the research director judge inappropriate as a subject
6.For pregnant women or women who are nursing
7. Nonambulatory patients.
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | KOJI |
| Middle name | |
| Last name | ISHIKAWA |
Organization
Showa University School of Medicine
Division name
Showa University School of Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai Shinagawa-ku
TEL
0337848543
koji.ishikawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | KOJI |
| Middle name | |
| Last name | ISHIKAWA |
Organization
Showa University School of Medicine
Division name
Department of Orthopaedics Surgery, Showa University School of Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai Shinagawa-ku
TEL
0337848543
Homepage URL
koji.ishikawa@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Showa University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamanashi Red Cross Hospital
Address
Department of Orthopaedic Surgery
Tel
0555-72-2222
soumuka@yamanashi-med.jrc.or.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
| 2020 | Year | 04 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045760
