UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041177 |
|---|---|
| Receipt number | R000047017 |
| Scientific Title | Analysis of fracture healing mechanism by high resolution CT (HR-pQCT): Effects of osteoporosis drugs |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2022/12/01 10:28:21 |
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Basic information
Public title
Analysis of fracture healing mechanism by high resolution CT (HR-pQCT): Effects of osteoporosis drugs
Acronym
Analysis of fracture healing mechanism by high resolution CT
Scientific Title
Analysis of fracture healing mechanism by high resolution CT (HR-pQCT): Effects of osteoporosis drugs
Scientific Title:Acronym
Analysis of fracture healing mechanism by high resolution CT
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of teriparatide on fracture healing by analyzing longitudinal data of patients who had a distal radius fracture and osteoporosis and were treated with a surgery and teriparatide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in cortical bone mineral density at fracture site from 4 to 24 weeks after injury
Key secondary outcomes
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1, Patients who have undergone osteosynthesis for distal radius fractures
2, Patients who are scheduled to receive daily treatment with teriparatide for osteoporosis
3, Age 50 and over, gender is female
Key exclusion criteria
1. Patients with diseases that affect fracture healing
2. Patients who are receiving drug treatment that affects fracture healing
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ko |
| Middle name | |
| Last name | Chiba |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Orthopedics Surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7321
ngs.hrpqct@gmail.com
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Chiba |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Orthopedics Surgery
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7321
Homepage URL
ngs.hrpqct@gmail.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Orthopedics and Traumatology Foundation, Inc
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
| 2020 | Year | 08 | Month | 17 | 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
| 2020 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center research.
The subjects were female 50 years old or older who had a distal radius fracture and osteoporosis and had undergone osteosynthesis, and is scheduled to be treated with daily teriparatide.
Survey items are background information, bone mineral density, high-resolution CT (HR-pQCT).
The primary endpoint is the change in cortical bone mineral density at the fracture site from 4 to 24 weeks after surgery.
The secondary endpoints are changes in bone mineral density and microstructure at cortical and cancellous bones in the distal radius between baseline, 4, 12, and 24 weeks after surgery.
Management information
Registered date
| 2020 | Year | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047017
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
