UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032892 |
|---|---|
| Receipt number | R000037505 |
| Scientific Title | Efficacy of Japanese osteoporosis liaison service for secondary fracture prevention |
| Date of disclosure of the study information | 2018/06/06 |
| Last modified on | 2023/06/10 09:26:53 |
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Basic information
Public title
Efficacy of Japanese osteoporosis liaison service for secondary fracture prevention
Acronym
JOLS study
Scientific Title
Efficacy of Japanese osteoporosis liaison service for secondary fracture prevention
Scientific Title:Acronym
JOLS study
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Geriatrics | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy of osteoporosis liaison service for secondary fracture prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical fragile fracture during 24 months after osteoporotic fracture
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food | Behavior,custom |
Interventions/Control_1
Osteoporosis liaison service within 3 months after the fracture. In addition, the researchers remind the patients of the importance of the treatment at 6, 12 and 24 months after the fracture.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Postmenopausal women or male equal to or over 50 years old
2. Primary osteoporosis
3. Admission in hospital due to new clinical vertebral fracture or hip fracture
Key exclusion criteria
1. Bone metabolic diseases including primary hyperparathyroidism
2. Patients on hemodialysis and after kidney transplantation
3.Unwillingness to participate the study
4. Inappropriate patients due to clinical information
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Suzuki |
Organization
Fujita Health University
Division name
Department of Endocrinology and Metabolism
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 4701192 Japan
TEL
0562939242
aslapin@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Suzukui |
Organization
Fujita Health University
Division name
Department of Endocrinology and Metabolism
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 4701192 Japan
TEL
0562939242
Homepage URL
aslapin@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Japan Osteoporosis Society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research promotion and support headquarters, Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 4701192 Japan
Tel
0562-93-2865
kenshien@fujita-hu.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
| 2018 | Year | 06 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037505
