UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019566 |
|---|---|
| Receipt number | R000022555 |
| Scientific Title | Superiority of Para-thyroid hormone Therapy for Healing of bone fracture |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2020/11/02 09:22:21 |
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Basic information
Public title
Superiority of Para-thyroid hormone Therapy for Healing of bone fracture
Acronym
S-Pth study
Scientific Title
Superiority of Para-thyroid hormone Therapy for Healing of bone fracture
Scientific Title:Acronym
S-Pth study
Region
| Japan |
Condition
Condition
lumbar spinal stensis
cervical spondylotic myelopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify the effect of daily and weekly PTH and bisphosphonate on the surgical outcomes of lumbar spinal stnosis and cervical spondylotic myelopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery rate of JOA scores at 24 year postoperatively
Key secondary outcomes
JOACMEQ
JOABPEQ
SF-36
VAS
bone union rate
screw loosenisng rate
BMD
new fracture rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bisphosphonate group as control group. This group is given Alendronate Sodium Hydrate (0.9mg/4week) from immediately after operation to 24 month after operation.
Interventions/Control_2
Daily PTH group. This group is given Teriparatide (0.02mg/day) from immediately after operation to 12 month after operation. Between 12month and 24 month after oepration, we give Calcium L-ASPARTATE(1.2g/day) to this group.
Interventions/Control_3
Weekly PTH group. This group is given Teriparatide (0.0565mg/week) from immediately after operation to 12 month after operation. Between 12month and 24 month after oepration, we give Calcium L-ASPARTATE(1.2g/day) to this group.
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
Male and Female
Key inclusion criteria
1: patient who undergone the spinal surgery for LSS or CSM
2: patieit who fullfil the criteria of osteoporosis
3: patient whose age is more than 60 y.o.
4: patient who agree with this study, with well understanding
Key exclusion criteria
1: patient who already taken the medicine for porosis before surgery.
2: patient who is tought to be hard to continue the study.
3: patient with OPLL or OYL
4: patient who is as an outpatieents of dentist
5: patient who has high risk of osteosarcoma
6: patient with hypercalcemia
7: patient with malignant tumor
8: patient with metabolic bone disease
9: patient who is taking digitalis.
10: patient with allergy for bisphosphonat or teriparatide
11: patient whose renal dysfunction
12: pregnant
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinobu Suzuki |
Organization
Osaka City University
Division name
Orthopedics
Zip code
Address
1-5-7,Asahicho,Abenoku,Osakasi,Japan
TEL
06-6645-3851
a-suzuki@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinobu Suzuki |
Organization
Osaka City University
Division name
Orthopedics
Zip code
Address
1-5-7,Asahicho,Abenoku,Osakasi,Japan
TEL
06-6645-3851
Homepage URL
seikei@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopedic Surgery, Osaka City University Graduate School of Medicine
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
| 2015 | Year | 11 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022555
