UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023344 |
|---|---|
| Receipt number | R000026892 |
| Scientific Title | The efficacy of teriparatide for the bone strength of patients suffered proximal femoral fracture, evaluated by computed tomographic finite element analysis |
| Date of disclosure of the study information | 2016/07/26 |
| Last modified on | 2019/08/19 13:50:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy of teriparatide for the bone strength of patients suffered proximal femoral fracture, evaluated by computed tomographic finite element analysis
Acronym
The efficacy of teriparatide for the bone strength of patients suffered proximal femoral fracture, evaluated by computed tomographic finite element analysis
Scientific Title
The efficacy of teriparatide for the bone strength of patients suffered proximal femoral fracture, evaluated by computed tomographic finite element analysis
Scientific Title:Acronym
The efficacy of teriparatide for the bone strength of patients suffered proximal femoral fracture, evaluated by computed tomographic finite element analysis
Region
| Japan |
Condition
Condition
Proximal femoral fracture
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether teriparatide will affect the femoral neck bone strength for the osteoporotic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone strength of proximal femur by CT/FEA
Key secondary outcomes
Bone material density of proximal femur
Value of bone metabolism markers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medication of recombinant human parathyroid hormone (teriparatide) by subcutaneous injection by oneself once a day for two years.
Interventions/Control_2
control
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
post operative patients with proximal femoral fractures over 65 years able to ambulate independently
Key exclusion criteria
Poor condition by suffering severe renal or heart disorder
Not able to evaluate femoral CT imaging or DXA
Having complication of secondary osteoporosis
Having some medication for osteoporosis
Having contraindication for teriparatide
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Fukushima |
Organization
Saku Central Hospital Advanced Care Center
Division name
Orthopaedic surgery
Zip code
Address
3400-28, Nakagomi, Saku City, Nagano Pref., 385-0051, Japan
TEL
0267-62-8181
ctroffice@sakuhp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Tano |
Organization
Saku Central Hospital Advanced Care Center
Division name
Orthopaedic surgery
Zip code
Address
3400-28, Nakagomi, Saku City, Nagano Pref., 385-0021, Japan
TEL
0267-62-8181
Homepage URL
ctroffice@sakuhp.or.jp
Sponsor or person
Institute
Saku Central Hospital Advanced Care Center
Institute
Department
Personal name
Funding Source
Organization
Saku Central Hospital Advanced Care Center
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
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
| 2016 | Year | 07 | Month | 26 | 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
| 2014 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 26 | Day |
Last modified on
| 2019 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026892
