UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057023 |
|---|---|
| Receipt number | R000065175 |
| Scientific Title | Clinical Results of abaloparatide for osteoporosis treatment |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/02/13 21:41:04 |
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Basic information
Public title
Clinical Results of abaloparatide for osteoporosis treatment
Acronym
Clinical Results of abaloparatide for osteoporosis treatment
Scientific Title
Clinical Results of abaloparatide for osteoporosis treatment
Scientific Title:Acronym
Clinical Results of abaloparatide for osteoporosis treatment
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the treatment outcomes of abaloparatide in real-world clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in lumbar and proximal femur bone mineral density, changes in bone metabolism markers, incidence of fractures, and incidence of side effects after 18 months of abaloparatide injections
Key secondary outcomes
Changes in lumbar spine and proximal femur bone mineral density, changes in bone metabolism markers, incidence of fractures, and incidence of side effects in sequential therapy after abaloparatide treatment.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Severe osteoporosis with a history of
1) fractures in two or more locations
2) YAM < 60%
3) a history of one fracture + YAM < 65%
4) vertebral fracture collapse rate > 40%.
Patients who can provide written consent regarding this study.
Key exclusion criteria
Patients who are contraindicated or require caution when administering abaloparatide
Malignant tumors
Patients who are currently pregnant, breastfeeding, or wish to become pregnant
Individuals who are unable to self-inject
Individuals who cannot provide consent for research
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Rui |
| Middle name | |
| Last name | Niimi |
Organization
Niimi orthopaedics surgery clinic
Division name
Orthopaedic surgery
Zip code
5110934
Address
2029, Ako Kuwanas city Mie prefecture
TEL
0594332133
furikakefuri@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | Niimi |
Organization
Niimi orthopaedics surgery clinic
Division name
Orthopaedic surgery
Zip code
5110934
Address
2029, Ako Kuwana city Mie prefecture
TEL
0594332133
Homepage URL
https://niimi-op.jp/
furikakefuri@hotmail.co.jp
Sponsor or person
Institute
Niimi orthopaedics surgery clinic
Institute
Department
Personal name
Niimi Rui
Funding Source
Organization
Niimi orthopaedics surgery clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niimi orthopaedic surgery clinic
Address
2029, Ako Kuwana city Mie prefecture
Tel
0594332133
furikakefuri@hotmail.co.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
| 2025 | Year | 03 | 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
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2037 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2037 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2040 | Year | 01 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065175
