UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055105 |
|---|---|
| Receipt number | R000062637 |
| Scientific Title | Comparison of efficacy of sequential treatment with romosozumab or denosumab for bisphosphonate-resistance glucocorticoid-induced osteoporosis |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/12/07 11:10:51 |
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Basic information
Public title
Comparison of efficacy of sequential treatment with romosozumab or denosumab for bisphosphonate-resistance glucocorticoid-induced osteoporosis
Acronym
Comparison of efficacy of sequential treatment with romosozumab or denosumab for bisphosphonate-resistance glucocorticoid-induced osteoporosis
Scientific Title
Comparison of efficacy of sequential treatment with romosozumab or denosumab for bisphosphonate-resistance glucocorticoid-induced osteoporosis
Scientific Title:Acronym
RoDeO study
Region
| Japan |
Condition
Condition
Glucocorticoid-induced osteoporosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of switching to romosozumab or denosumab for patients with bisphosphonate-resistance glucocorticoid-induced osteoporosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the percent change of bone mineral density of the lumbar spine (L2-4), femoral neck and total hip at 52 weeks in the romosozumab and denosumab groups.
Key secondary outcomes
1) Compare the percent change of bone mineral density of the lumbar spine, femoral neck and total hip between the romosozumab and denosumab groups at 26, 78, 104, 130, and 156 weeks.
2) Compare the percent change of bone mineral density of the trochanter and the change of bone turnover markers at 26, 52, 78, 104, 130, and 156 weeks between the romosozumab and denosumab groups.
3) Compare the incidence of new fractures between the romosozumab and denosumab groups.
4) Compare the incidence of adverse events between the romosozumab and denosumab groups.
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Romosozumab group: Patients receive romosozumab subcutaneously with a discontinuation of bisphosphonate. After 12 months of treatment, romosozumab will be discontinued and denosumab will be started. At week 156, final observation is performed.
Interventions/Control_2
Denosumab group: Patients receive denosumab subcutaneously once every 6 months with a discontinuation of bisphosphonate. At week 156, final observation is performed.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients 40 years of age or older receiving glucocorticoids (prednisolone equivalent 2.5 mg/day or more) and bisphosphonates for at least 6 months.
2) Patients with a T-score of -2.0 or less in bone mineral density of the lumbar spine, femoral neck or total hip by DEXA.
3) Patients with a history of fragility fracture.
4) Patients with a probability of major osteoporotic fracture greater than or equal to 20% or a probability of proximal femoral fracture greater than or equal to 3% at 10 years by FRAX.
5) Patients who have provided written informed consent.
Key exclusion criteria
1) Patients with contraindications to romosozumab or denosumab.
2) Patients with active infection or malignancy.
3) Patients who are currently pregnant, lactating, or willing to get pregnant.
4) Patients who do not give consent to this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mai |
| Middle name | |
| Last name | Kawazoe |
Organization
Toho University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
mai.kawazoe@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Kawazoe |
Organization
Toho University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3462-4151
Homepage URL
mai.kawazoe@med.toho-u.ac.jp
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University School of Medicine
Address
6-11-1 Omori-nishi, Ota-ku
Tel
03-3762-4151
mai.kawazoe@med.toho-u.ac.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
| 2024 | Year | 08 | 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 | 06 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 10 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062637
