UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052357 |
|---|---|
| Receipt number | R000059742 |
| Scientific Title | Effect of Injection Site Pain in Patients Receiving Romosozumab for Osteoporosis |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2025/11/11 10:29:37 |
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Basic information
Public title
Effect of Injection Site Pain in Patients Receiving Romosozumab for Osteoporosis
Acronym
Effect of Injection Site Pain in Patients Receiving Romosozumab for Osteoporosis
Scientific Title
Effect of Injection Site Pain in Patients Receiving Romosozumab for Osteoporosis
Scientific Title:Acronym
Effect of Injection Site Pain in Patients Receiving Romosozumab for Osteoporosis
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
The aim of this study is to compare the effects of injection sites (upper arm vs abdomen) on pain and injection site reactions in patients receiving subcutaneous romosozumab for osteoporosis. The study also explores the relationship between pain intensity and treatment adherence.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Injection site pain
Key secondary outcomes
Injection site reactions and treatment efficacy (BMD and BTM)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group receiving two romosozumab injections in the upper arms
Interventions/Control_2
Group receiving two romosozumab injections in the abdomen
Interventions/Control_3
Group receiving one romosozumab injection in the upper arm and one in the abdomen (within-subject comparison)
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
Patients diagnosed with osteoporosis and initiated on pharmacologic therapy who are enrolled in the FUJIGOKO Study (IRB approved) and treated with romosozumab.
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
207
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
No funding source
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
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
224
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
| 2020 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059742
