UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038035 |
|---|---|
| Receipt number | R000042974 |
| Scientific Title | Teriparatide Once Weekly Efficacy Research for primary prevention of Glucocorticoid-induced Osteoporosis |
| Date of disclosure of the study information | 2019/09/20 |
| Last modified on | 2021/10/04 10:04:26 |
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Basic information
Public title
Teriparatide Once Weekly Efficacy Research for primary prevention of Glucocorticoid-induced Osteoporosis
Acronym
TOWER-GO post hoc analysis
Scientific Title
Teriparatide Once Weekly Efficacy Research for primary prevention of Glucocorticoid-induced Osteoporosis
Scientific Title:Acronym
TOWER-GO post hoc analysis
Region
| Japan |
Condition
Condition
Glucocorticoid-induced osteoporosis (GIOP)
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of once-weekly teriparatide formulation for the primary prevention of glucocorticoid-induced osteoporosis using post hoc analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of changes in bone mineral density of lumbar spine after 72 weeks
Key secondary outcomes
Rate of change in lumbar spine BMD after 24 and 48 weeks
Ratio of the vertebral fractures
Ratio of the non-vertebral fractures
Rate of change in bone metabolism marker
Rate of improvement in lower back pain
Rate of improvement in QOL
Adverse events
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Objects who had not been taking oral steroid at a dose equivalent to 5mg/day of prednisolone or higher at least three months
2)Objects who was also treated by experimental drug with the once, and was estimated even sometime about the validity after treatment starting
Key exclusion criteria
none
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Hisaji |
| Middle name | |
| Last name | Oshima |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Connective tissue Diseases
Zip code
152-8902
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8902 Japan
TEL
03-3411-0111
hoshimamac@mac.com
Public contact
Name of contact person
| 1st name | Terufumi |
| Middle name | |
| Last name | Yokoyama |
Organization
APO PLUS STATION Co., Ltd.
Division name
CRO Business Division
Zip code
103-0027
Address
Front Place Nihonbashi, 2-14-1 Nihonbashi, Chuo-ku, Tokyo, 103-0027 Japan
TEL
03-6386-8800
Homepage URL
t2-yokoyama@apoplus.co.jp
Sponsor or person
Institute
Glucocorticoid-induced osteoporosis research society
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tokyo Medical Center IRB
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8902 Japan
Tel
03-3411-0111
215-rinri@mail.hosp.go.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
| 2019 | Year | 09 | Month | 20 | 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
78
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary preventive effect is considered by putting post hoc analysis to the data TOWER-GO study gave into effect about the validity of once-weekly teriparatide formulation to glucocorticid-induced osteoporosis.
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2021 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042974
