UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033118 |
|---|---|
| Receipt number | R000037768 |
| Scientific Title | Effect of once-weekly teriparatide for bone metabolism in primary osteoprosis patients. |
| Date of disclosure of the study information | 2018/06/23 |
| Last modified on | 2020/08/26 12:17:33 |
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Basic information
Public title
Effect of once-weekly teriparatide for bone metabolism in primary osteoprosis patients.
Acronym
Changes in markers by Weekly-Teriparatide.
Scientific Title
Effect of once-weekly teriparatide for bone metabolism in primary osteoprosis patients.
Scientific Title:Acronym
Changes in markers by Weekly-Teriparatide.
Region
| Japan |
Condition
Condition
Osteoprosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observe the relationship between bone metabolism marker change and bone density by treatment with teriparatide once a week.
Basic objectives2
Others
Basic objectives -Others
Bone metabolism markers measure P1NP, TRAP-5b, osteocalcin, sclerostin.
Bone density measures femur neck and lumbar spine.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observation of bone density and bone metabolism marker by treatment with Teriparatide during 18 months of treatment.
Bone metabolism markers measure P1NP, TRAP-5b, osteocalcin, sclerostin.
Bone density measures femur neck and lumbar spine.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women with YAM 70 percentage or less with value of bone mineral density.
Osteoporotic fracture has occurred in men and women with YAM less than 80 percentage in BMD.
Key exclusion criteria
Patients with diabetes, rheumatoid arthritis,respiratory,endocrinological and other disease and drug use that may affect bone metabolism were excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Terumasa |
| Middle name | |
| Last name | Ikeda |
Organization
Kindai University Hospital
Division name
Orthopaedic surgery
Zip code
589-8511
Address
377-2,Ohono-Higashi Osaka-Sayama city Osaka
TEL
0723660221
tikeda@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Terumasa |
| Middle name | |
| Last name | Ikeda |
Organization
Kindai University Hospital
Division name
Orthopaedic surgery
Zip code
589-8511
Address
377-2,Ohono-Higashi Osaka-Sayama city Osaka
TEL
0723660221
Homepage URL
https://www.med.kindai.ac.jp/ortho/
tikeda@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Hospital, Department of Orthopaedic surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kindai University Hospital
Address
377-2 Ohno-higashi Osaka-sayama city
Tel
0723660221
zizen@med.kindai.ac.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 23 | 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
| 2013 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 26 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 26 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
There is no special information.
Management information
Registered date
| 2018 | Year | 06 | Month | 23 | 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=R000037768
