UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015573
Receipt No. R000018098
Scientific Title Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture
Date of disclosure of the study information 2014/11/01
Last modified on 2018/10/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture
Acronym A-TOP/JOINT-05
Scientific Title Fracture inhibitory effect verification test of osteoporosis drug for primary osteoporosis patients at high risk of fracture
Scientific Title:Acronym A-TOP/JOINT-05
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Medicine in general Endocrinology and Metabolism Obsterics and gynecology
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The head-to-head comparison of once
weekly teriparatid and alendronate
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Incidence of new vertebral fracture
at 72 weeks
Key secondary outcomes Incidence of new vertebral fracture and non-vertebral fracture at 72 and 120 weeks
Incidence of new vertebral fracture
Exacerbation of vertebral fracture incidence
BMD rate of change
QOL rate of change
Bone structure analysis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 once weekly teriparatide
Interventions/Control_2 alendronate
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
75 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria A document agreement of the clinical study participation is provided and intends for a patient meeting all the following standards
1.Primary osteoporosis
2.a Japanese patient 75 years or older
3.postmenopausal women
4.The patient that an independence walk is possible
5.The patient who satisfies any of the following
Patient with less than in bone density 60% of YAM or less than -3.3SD
The patient who has vertebral body bone fractures more than two to the fourth lumbar vertebrae from the fourth thoracic vertebra at the time of registration
Patient having a bone fracture of grade 3
The patient who has the past of the proximal thighbone bone fracture
Key exclusion criteria 1.Secondary osteoporosis
2.bone loss Disease other than osteoporosis
3.diseases that affect the strength of the vertebral body
4.hypersensitivity
5.use of contraindicated therapeutic drugs
6.severe complications such as heart disease, liver disease, renal disease
7.problem with the reliability of the interview data
8.inpatient
9.Patients treated with teriparatide in the past
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Mori
Organization Seirei Hamamatsu General Hospital
Division name chief department of Bone&Joint and Orthopaedic surgery
Zip code
Address 2-12-12Sumiyoshi,Chuo-ku,Hamamtsu,Shizuoka
TEL 053-474-2222
Email stmori@sis.seirei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miyazaki Teruhiko
Organization Public Health Research Foundation
Division name Comprehensive Support Project for
Zip code
Address 1-1-7Nishiwaseda,Shinjuku-ku,Tokyo,japan
TEL 03-5287-2633
Homepage URL http://www.a-top.jp
Email miyazaki@csp.or.jp

Sponsor
Institute Research committee of A-TOP
Institute
Department

Funding Source
Organization Public Health Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2014 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
2014 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 04 Day
Last follow-up date
2020 Year 05 Month 30 Day
Date of closure to data entry
2020 Year 07 Month 31 Day
Date trial data considered complete
2020 Year 10 Month 31 Day
Date analysis concluded
2020 Year 12 Month 29 Day

Other
Other related information

Management information
Registered date
2014 Year 10 Month 31 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018098

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.