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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024503
Receipt No. 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 2018/04/09

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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
Middle name
Last name Takafumi hagiwara
Organization Takarazuka city hospital
Division name Department of rheumatology
Zip code
Address kohama 4-5-1 Takarazuka city
TEL 0797-87-1161
Email college@katzenauge.sakura.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Hagiwara
Organization Takarazuka city hospital
Division name Division of rheumatology
Zip code
Address Kohama 4-5-1 Takarazuka city
TEL 0797-87-1161
Homepage URL
Email college@katzenauge.sakura.ne.jp

Sponsor
Institute Department of rheumatology, Takarazuka city hospital
Institute
Department

Funding Source
Organization Self funding

Division 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
Address
Tel
Email

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 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
2013 Year 02 Month 01 Day
Date of IRB
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
2018 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028201

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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