UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032090 |
|---|---|
| Receipt number | 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 | 2020/08/26 12:21:41 |
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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
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
tikeda@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Hospital
Department of Orthopaedic surgery
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 31 | Day |
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
| 2020 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036609
