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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032090
Receipt No. R000036609
Scientific Title Effect of once-weekly teriparatide for bone metabolism in praimary osteoprosis patients.
Date of disclosure of the study information 2018/06/28
Last modified on 2018/10/25

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Basic information
Public title Effect of once-weekly teriparatide for bone metabolism in praimary osteoprosis patients.
Acronym Effect of once-weekly teriparatide for bone metabolism.
Scientific Title Effect of once-weekly teriparatide for bone metabolism in praimary osteoprosis patients.
Scientific Title:Acronym Effect of once-weekly teriparatide for bone metabolism.
Region
Japan

Condition
Condition osteoprosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of once-weekly teriparatide for bone metabolism.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in the serum sclerostin concentration during the 18-month treatment.
Key secondary outcomes Relationship between change of BMD and sclerostin during the 18-month treatment.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with once-weekly teriparatide was investigated change of BMD and change of serum sclerostine concentration during 18 months.Bone metabolism markers are measured before treatment, 1, 3, 6, 12 months and 18 months after treatment. BMD and whole spine Xp are assessed before treatment, 12 months and 18 months.
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
60 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Osteoporosis was diagnosed by BMD in less than 70% of the young adult mean (YAM) in the Japanese population or the presence of fragility fractures and BMD in less than 80% of YAM.
Key exclusion criteria Patients who are already have treated for osteporosis. Rheumatoid arthritis, dialysis patients and high vaule of PTH patients.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Akagi
Organization Kindai University Hospital
Division name Orthopaedic surgery
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama Osaka
TEL 072-366-0221
Email tikeda@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Terumasa Ikeda
Organization Kindai University Hospital
Division name Orthopaedic surgery
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama Osaka
TEL 072-366-0221
Homepage URL
Email tikeda@med.kindai.ac.jp

Sponsor
Institute Kindai University Hospital
Department of Orthopaedic surgery
Institute
Department

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
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
2018 Year 06 Month 28 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 Completed
Date of protocol fixation
2013 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 09 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
2019 Year 11 Month 30 Day
Date trial data considered complete
2019 Year 11 Month 30 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 03 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036609

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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