UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055413 |
|---|---|
| Receipt number | R000063328 |
| Scientific Title | Efficacy of romosozumab in preventing contralateral secondary fractures in patients with proximal femur fractures |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2025/08/06 11:34:27 |
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Basic information
Public title
Efficacy of Romosozumab in preventing contralateral secondary fractures in patients with proximal femur fractures
Acronym
Efficacy of romosozumab in preventing contralateral secondary fractures in patients with proximal femur fractures
Scientific Title
Efficacy of romosozumab in preventing contralateral secondary fractures in patients with proximal femur fractures
Scientific Title:Acronym
Efficacy of romosozumab in preventing contralateral secondary fractures in patients with proximal femur fractures
Region
| Japan |
Condition
Condition
Proximal femur fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the preventive effect of romosozumab on secondary fractures following proximal femoral fractures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of secondary fractures on the contralateral side of proximal femoral fractures within one year after surgery
Key secondary outcomes
Vertebral fracture incidence, bone mineral density change rate (femoral neck, L2-4), cumulative mortality, level of care required, walking function, Barthel Index, Locomotion 25, and prospective cohort study to extract risk factors for secondary fractures of the proximal femur
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Romosozumab 210mg administered once a month for 12 months
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who suffered a proximal femoral fracture and were admitted to Kumamoto University Hospital or the collaborative research institute.
Key exclusion criteria
1. Secondary fracture (pathological fracture due to metastatic or primary bone tumor, etc.)
2. Minor
3. Injury due to industrial accident or traffic accident
4. History of ischemic heart disease or cerebrovascular disorder within the past year
5. Hypocalcemia
6. Received romosozumab treatment before participating in the study
7. Non-osteoporotic fracture due to high-energy trauma
8. History of proximal femoral fracture
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Miyamoto |
Organization
Kumamoto University
Division name
Kumamoto University Graduate School of Life Sciences, Department of Orthopedic Surgery
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto
TEL
096-373-5226
kumamoto.kstop.extention@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Takashima |
Organization
Kumamoto University
Division name
Kumamoto University Graduate School of Life Sciences, Department of Orthopedic Surgery
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto
TEL
096-373-5226
Homepage URL
kumamoto.kstop.extention@gmail.com
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Amgen Inc.(NASDOQ:AMGN)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Graduate School of Life Sciences
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto
Tel
096-373-5657
N/A
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
| 2024 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063328
