UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008610 |
|---|---|
| Receipt number | R000010119 |
| Scientific Title | To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration on local and systemic bone metabolism during healing period after vertebral fracture. |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2017/10/23 17:12:51 |
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Basic information
Public title
To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration on local and systemic bone metabolism during healing period after vertebral fracture.
Acronym
To test different effects of daily and weekly teriparatide on local and systemic bone metabolism during fracture healing after vertebral fracture
Scientific Title
To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration on local and systemic bone metabolism during healing period after vertebral fracture.
Scientific Title:Acronym
To test different effects of daily and weekly teriparatide on local and systemic bone metabolism during fracture healing after vertebral fracture
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration during healing period after vertebral fracture on the fracture site, pain and systemic bone turnover, and different indication of those two agents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Bone metabolic markers
Key secondary outcomes
Vertebral and femoral bone mineral density, numbers of new vertebral fractures during the study period, VAS, JOQOL, RDQ, QUEST, and bony union
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teriparatide Acetate
Interventions/Control_2
Teriparatide (Genetical Recombination)
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
| Not applicable |
Gender
Female
Key inclusion criteria
Post-menopausal women of 60-y-o or above with sever osteoporosis who have a fresh vertebral fracture and understand, and literary approve to be included to this study.
#1; The fresh vertebral fracture, what occur during 2 weeks, is defined with history, physical examination and X-ray appearances and/or MRI of spine.
#2; The sever osteoporosis is diagnosed to a patient whose point is accounting for 3 or above by our appraisal standard as follow.
Point
70%YAM>BMD=/>65% 1
65%YAM>BMD=/>60% 2
60%YAM>BMD 3
New vertebral fracture 1
Using corticosteroid 1
Old vertebral fracture =1 1
Old vertebral fractures >1 2
Sever osteoporosis: total 3=/<
Key exclusion criteria
1. Patients in whom study drugs (teriparatide) are contraindicated
2. Serious renal, hepatic, or cardiac disease
3. Secondly osteoporosis
4. Patients who are considered inappropriate for enrollment by the investigator for any other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Tanaka |
Organization
Saitama Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
Morohongo 38, moroyamacho, Irumagun, Saitamaken, Japan
TEL
049-276-1238
tnk_sny@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Tanaka |
Organization
Saitama Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
350-0495, Morohongo 38, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL
049-276-1238
Homepage URL
tnk_sny@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Osteoporosis 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
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
埼玉医科大学病院（埼玉県）、埼玉医科大学かわごえクリニック（埼玉県）、小川日本赤十字病院（埼玉県）、関越病院(埼玉県)、若葉病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 06 | 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
| 2012 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 03 | Day |
Last modified on
| 2017 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010119
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
