UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024503 |
|---|---|
| Receipt number | R000028201 |
| Scientific Title | Head to head comparison teriparatide products daily versus weekly for osteoporosis patients. |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2023/04/27 10:57:01 |
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Basic information
Public title
Head to head comparison teriparatide products daily versus weekly for osteoporosis patients.
Acronym
The Efficacy of teriparatide products daily vs weekly.
Scientific Title
Head to head comparison teriparatide products daily versus weekly for osteoporosis patients.
Scientific Title:Acronym
The Efficacy of teriparatide products daily vs weekly.
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Therapeutic efficacy comparison with each arm using teriparatide and teriparatide acetate in osteoporosis patients.
Basic objectives2
Others
Basic objectives -Others
Continuation rate of both teriparatide products.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The new bone fracture incidence until 18 months after treatment intervention.
Key secondary outcomes
Change of the serologic marker about bone metabolism and the bone density 1, 6, 12, 18 and 30 months later.
The new bone fracture incidence until 30 months after treatment intervention.
serologic marker: TRACP-5b, total P1NP, 1,25(OH)2VitD3, Ca, IP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teriparatide 20 microgram sc daily (104weeks) -> Denosmab 60mg Q26weeks (52weeks)
Interventions/Control_2
Teriparatide acetate 56.5 microgram sc weekly (72weeks) -> Denosmab 60mg Q26weeks (40weeks)
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
Patients of post menopausal osteoporosis, male osteoporosis and glucocorticoid induced osteoporosis.
Key exclusion criteria
The patient who has poor control of the underlying disease in the glucocorticoid osteoporosis
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Hagiwara |
Organization
Takarazuka city hospital
Division name
Department of rheumatology
Zip code
665-0827
Address
kohama 4-5-1 Takarazuka city
TEL
0797-87-1161
college@katzenauge.sakura.ne.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Hagiwara |
Organization
Takarazuka city hospital
Division name
Department of rheumatology
Zip code
665-0827
Address
Kohama 4-5-1 Takarazuka city
TEL
0797-87-1161
Homepage URL
college@katzenauge.sakura.ne.jp
Sponsor or person
Institute
Department of rheumatology, Takarazuka city hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Department of rheumatology, Takarazuka city hospital
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
Takarazuka City Hospital
Address
Kohama 4-5-1 takarazuka city
Tel
08797-87-1161
takarazukarinken@jcom.zaq.ne.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
宝塚市立病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
55
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
To review the reading method of imaging evaluation.
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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | 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 | 10 | Month | 20 | Day |
Last modified on
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028201
