UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023985 |
|---|---|
| Receipt number | R000027612 |
| Scientific Title | Single arm phase 2 clinical trial of discontinuation of bisphosphonate in patients with aitoimmune diseases |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2023/09/20 13:49:31 |
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Basic information
Public title
Single arm phase 2 clinical trial of discontinuation of bisphosphonate in patients with aitoimmune diseases
Acronym
clinical trial of discontinuation of bisphosphonate in patients with aitoimmune diseases
Scientific Title
Single arm phase 2 clinical trial of discontinuation of bisphosphonate in patients with aitoimmune diseases
Scientific Title:Acronym
clinical trial of discontinuation of bisphosphonate in patients with aitoimmune diseases
Region
| Japan |
Condition
Condition
autoimmune diseases
Classification by specialty
| Medicine in general | Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify safety of discontinuation of bisphosphonate (BP) in patients with autoimmune diseases, who have been taking BP over five years and who are between 20-60 years old.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decreased bone mineral density of femoral neck five years after discontinuation of BP
Key secondary outcomes
1.incidence of beaking
2.incidence of typical femoral fracture
3.change of bone metabolic markers
4.incidence of atypical femoral fracture
5.adverse events
6.risk factors for beaking
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
discontinuation of BP and changing to vitamin D supplementation
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.age 20 - 60 years old
2.patients of Division of Clinical Nephrology and Rheumatology or Orthopedic Surgery in Niigata University
3.taking mainteinance dose of prednisolone(under 20 mg)
4.taking BP for over five years
5.T score measured by DEXA over -2.5
6.no evidence of past osteoporotic fracture
7.obtained written informed consent
Key exclusion criteria
1.unnecessary of BP according to guideline for the management and treatment of glucocorticoid-induced osteoporosis in Japan
2.inappropriate patients for the clinical trial
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroe |
| Middle name | |
| Last name | Sato |
Organization
Niigata University
Division name
Health Administration center
Zip code
951-8510
Address
2-8050, Ikarashi, Nishi-ku, Niigata, Niigata, Japan
TEL
025-262-6244
hiroes@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroe |
| Middle name | |
| Last name | Sato |
Organization
Niigata University Hospital
Division name
Division of Nephrology and Rheumatology
Zip code
951-8510
Address
1-754, Asahimachi-Dori, Chuo-ku, Niigata, Niigata, Japan
TEL
025-227-2200
Homepage URL
hiroes@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee of Niigata University
Address
1-757, Asahimachi-Dori, Chuo-ku, Niigata, Niigata, Japan
Tel
025-227-2005
ethics@adm.niigata-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
| 2017 | Year | 04 | Month | 01 | 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
64
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 | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 06 | 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
Management information
Registered date
| 2016 | Year | 09 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027612
| 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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