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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039278
Receipt No. 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 2020/07/28

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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
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
Email 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
Email ngs.hrpqct@gmail.com

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
Email 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
2020 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044798

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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