UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052340 |
|---|---|
| Receipt number | R000057206 |
| Scientific Title | Searching study for comparative examination in Forteo and OSTABALO in a proximal femoral fracture patient |
| Date of disclosure of the study information | 2023/09/28 |
| Last modified on | 2024/03/22 11:50:57 |
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Basic information
Public title
Searching study for comparative examination in Forteo and OSTABALO in a proximal femoral fracture patient
Acronym
Forteo vs OSTABALO
Scientific Title
Searching study for comparative examination in Forteo and OSTABALO in a proximal femoral fracture patient
Scientific Title:Acronym
Forteo vs OSTABALO
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This has for its object to compare safety with the validity of TeriparatideBS and Ostabalo which are a bone morphogenetic promotion pill targeted for the osteoporosis patients with a history of proximal femoral fracture of danger of a bone fracture.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hip bone density variation after 18 months
Key secondary outcomes
1.At the start of treatment and after 3, 6, 12, and 18 months
Bone density
Hip structure analysis
P1NP,TRACP-5b
2.At the start of treatment and after 6, 12, and 18 months
X-ray examination
Homocysteine,AGE
3.Persistence rate
4.Safety evaluation
Adverse event
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teriparatide
Interventions/Control_2
Abaloparatide Acetate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with proximal femur fracture,who comes under more than the following one of 1 items
Bone density;-2.5SD or less and Vulnerable fracture
Lumbar spine bone density;Less than -3.3SD
Existing vertebral fracture;More than 2
Semi-quantitative evaluation method results(Existing vertebral fracture)is Grade3
Fracture of femur in the past
2.The age of the time of the agreement merit,more than 20-years old
3.The patient by whom own injection is possible
4.The patient who could get documentary consent by free will of the back and the patient person himself which had the enough explanation in case of participation of this research
Key exclusion criteria
1.The patients with hypercalcemia
2.The patients considered to be at high risk of developing osteosarcoma
3.The patients with primary malignant or metastatic bone tumors
4.The patients with metabolic bone diseases other than osteoporosis
5.The patient with taboo Teriparatide and Abaloparatide Acetate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Mochizuki |
Organization
Kamagaya General Hospital
Division name
Plastic surgery
Zip code
273-0121
Address
929-6 Hatsutomi,Kamagaya-City Chiba
TEL
047-798-8266
chiken@kamagaya-hp.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Mochizuki |
Organization
Kamagaya General Hospital
Division name
Plastic surgery
Zip code
273-0121
Address
929-6 Hatsutomi,Kamagaya-City Chiba
TEL
047-798-8266
Homepage URL
chiken@kamagaya-hp.jp
Sponsor or person
Institute
Kamagaya General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kamagaya General Hospital
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
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo
Tel
03-3263-4801
mirai-ec4@mirai-iryo.com
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 | 09 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | 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 | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057206
