UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052357 |
|---|---|
| Receipt number | R000059742 |
| Scientific Title | The Effects of Short-Term Romosozumab Treatment on Hip Strength |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/03/26 05:16:46 |
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Basic information
Public title
The Effects of Short-Term Romosozumab Treatment on Hip Strength
Acronym
The Effects of Short-Term Romosozumab Treatment on Hip Strength
Scientific Title
The Effects of Short-Term Romosozumab Treatment on Hip Strength
Scientific Title:Acronym
The Effects of Short-Term Romosozumab Treatment on Hip Strength
Region
| Japan | North America |
Condition
Condition
Patients with osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While DXA testing traditionally determines the efficacy of osteoporosis treatments over 1-2 years, immediate improvements in bone health are vital to reduce fracture risk. This study assesses the early biomechanical responses observed after a 3-month course of romosozumab treatment. Data was sourced from the FUJIGOKO Study, which registers patients undergoing osteoporosis treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone strength of the hip
Key secondary outcomes
3D-BMD(Bone mineral density)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 55 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Data will be collected retrospectively from FUJIGOKO STUDY (IRB approved: registry data for the patients who diagnose and started treatment). Key inclusion criteria; Diagnosed osteoporosis treated with romosozumab / Have DXA, Blood test and CT scan at drug initiation, 3 months and 12 months.
Key exclusion criteria
The exclusion criteria were patients with illnesses affecting bone and calcium metabolism or bone disorders other than osteoporosis, any malignant conditions, fresh fracture, scheduled surgery, severe renal dysfunction or history of cardiovascular events.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ishikawa |
Organization
Department of Orthopaedics Surgery, Showa University
Division name
Yoshifumi Kudo
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8543
koji.ishikawa@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ishikawa |
Organization
Showa University
Division name
Department of Orthopaedics Surgery
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
0337848543
Homepage URL
koji.ishikawa@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Amgen
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamanashi Red Cross Hospital
Address
6663-1 Funatsu Fujikawaguchiko-machi Minamitsuru-gun,Yamanashi, 401-0301, Japan
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
| 2023 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data will be collected retrospectively from FUJIGOKO STUDY (IRB approved: registry data for the patients who diagnose and started treatment). Key inclusion criteria; Diagnosed osteoporosis treated with romosozumab / Have DXA, Blood test and CT scan at drug initiation, 3 months and 12 months. Collected data will be analyzed using advanced biomechanical analysis.
Management information
Registered date
| 2023 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059742
