UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039278 |
|---|---|
| Receipt number | R000044798 |
| Scientific Title | Effects of osteoporosis drugs on bone microstructure:analysis by high-resolution CT (HR-pQCT) |
| Date of disclosure of the study information | 2020/01/29 |
| Last modified on | 2021/08/03 11:28:24 |
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Basic information
Public title
Effects of osteoporosis drugs on bone microstructure:analysis by high-resolution CT (HR-pQCT)
Acronym
Effects of osteoporosis drugs on bone microstructure:analysis by high-resolution CT (HR-pQCT)
Scientific Title
Effects of osteoporosis drugs on bone microstructure:analysis by high-resolution CT (HR-pQCT)
Scientific Title:Acronym
Effects of osteoporosis drugs on bone microstructure:analysis by high-resolution CT (HR-pQCT)
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the characteristics of changes in bone microstructure using HR-pQCT in patients treated with each osteoporosis drug.
This study is expected to provide a more detailed understanding of the mechanism of action of various drugs and provide important information for selecting drugs according to the disease state.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the following items before and 6 or 12 months after the start of treatment.
･ Bone density test: lumbar spine, femur / bone mineral density
･ Plain X-ray: Thoracic, lumbar / vertebral body fracture evaluation
･ Blood test: Ca, P, ALP, Alb, BUN, Cre, eGFR, iPTH, TRACP5b, P1NP, 25OH vitamin D
･ High-resolution CT: Radius, tibia / cortical bone microstructure, trabecular bone microstructure, estimated bone strength
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who newly use the following drugs for osteoporosis
1) Anti-sclerostin antibody + vitamin D preparation
2) PTH preparation (Teriparatide)
3) Anti-RANKL antibody (denosumab) + vitamin D preparation
4) Bisphosphonate preparation + Vitamin D preparation
5) SERM + vitamin D preparation or sex hormone preparation
6) Vitamin D preparation
(The selection of a therapeutic agent is usually determined based on the intentions of the patient and doctor in clinical practice.)
(Concomitant administration of vitamin D preparations is the recommended way of administration in usual practice.)
Key exclusion criteria
1.Cases contraindicated in drug use
2.Other patients who are judged inappropriate by the researchers etc.
Target sample size
175
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
Orthopedic surgery
Zip code
852-8501
Address
1-7-1Sakamoto 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 Hospital
Division name
Orthopedic surgery
Zip code
852-8501
Address
1-7-1Sakamoto 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
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Univercity Hospital Clinhical Research Ethics Committee
Address
1-7-1Sakamoto 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 | 01 | Month | 29 | 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
| 2019 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who newly use the following drugs for osteoporosis
1) Anti-sclerostin antibody + vitamin D preparation
2) PTH preparation (Teriparatide)
3) Anti-RANKL antibody (denosumab) + vitamin D preparation
4) Bisphosphonate preparation + Vitamin D preparation
5) SERM + vitamin D preparation
6) Vitamin D preparation
Changes in the following items before and 6 or 12 months after the start of treatment.
･ Bone density test: lumbar spine, femur / bone mineral density
･ Plain X-ray: Thoracic, lumbar / vertebral body fracture evaluation
･ Blood test: Ca, P, ALP, Alb, BUN, Cre, eGFR, iPTH, TRACP5b, P1NP, 25OH vitamin D
･ High-resolution CT: Radius, tibia / cortical bone microstructure, trabecular bone microstructure, estimated bone strength
Management information
Registered date
| 2020 | Year | 01 | Month | 28 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044798
| Research Plan | |
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| Registered date | File name |
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