UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013014 |
|---|---|
| Receipt number | R000015139 |
| Scientific Title | Preventive effects with teriparatide or alendronate on the progression of vertebral collapse |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2019/09/21 11:19:11 |
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Basic information
Public title
Preventive effects with teriparatide or alendronate on the progression of vertebral collapse
Acronym
T-WRAP (Teriparatide for new vertebral fractures to wedge deformity prevention study)
Scientific Title
Preventive effects with teriparatide or alendronate on the progression of vertebral collapse
Scientific Title:Acronym
T-WRAP (Teriparatide for new vertebral fractures to wedge deformity prevention study)
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the preventive effect of teriparatde or alendronate on the progression of vertebral collapse after osteoporotic vertebral fracture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression of vertebral collapse fracture
Key secondary outcomes
Pain, QOL, Bone turnover markers,
Bone mineral density
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women with fragility vertebral compression fracture
Key exclusion criteria
1. Patients with vertebral compression fractures which is not clear the time of injury.
2. Patients received teriparatide or denosumab within 6 months prior to the study.
3. Patients with contraindications of teriparatide or alendronate.
4. Patients with severe renal dysfunction, severe liver dysfunction, or severe heart disease.
5. Inappropriate patients to participate the study judged by primary physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ikeda, M.D., Ph. D. |
Organization
Ken-Ai Memorial Hospital
Division name
Orthopaedic Surgeon
Zip code
8114313
Address
1191 oaza kimori. Onga-machi onga-gun. Fukuoka. 811-4313 Japan
TEL
093-293-7090
s-ikeda@bc.iij4u.or.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Tanzawa |
Organization
EPS corporation
Division name
CEO Office
Zip code
1620814
Address
1-1, Shinogawamachi, Shinjyuku-ku, Tokyo Japan
TEL
03-5684-7797
Homepage URL
tanzawa517@eps.co.jp
Sponsor or person
Institute
Kitakyushu Osteoporosis Trial Unit
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matumoto Clinic IRB Organization
Address
ST Shibuya 2F, 1-15-14 Dogenzaka, Shibuya-ku Tokyo JAPAN
Tel
03-6416-1947
matsumoto@clinic-irb.com
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 | 02 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 30 | Day |
Last modified on
| 2019 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015139
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
