UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015202 |
|---|---|
| Receipt number | R000017674 |
| Scientific Title | Clinical investigation to examine the effect of bone formation of PTH on multilevel spinal implant surgery for vertebral degenerative disease associated with osteoporosis |
| Date of disclosure of the study information | 2014/09/18 |
| Last modified on | 2016/06/21 13:06:31 |
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Basic information
Public title
Clinical investigation to examine the effect of bone formation of PTH on multilevel spinal implant surgery for vertebral degenerative disease associated with osteoporosis
Acronym
Clinical investigation of PTH for multilevel spinal implant surgery
Scientific Title
Clinical investigation to examine the effect of bone formation of PTH on multilevel spinal implant surgery for vertebral degenerative disease associated with osteoporosis
Scientific Title:Acronym
Clinical investigation of PTH for multilevel spinal implant surgery
Region
| Japan |
Condition
Condition
Vertebral degeneration associated with Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of PTH on multilevel spinal implant surgery on
-The enhancement effect on bony fusion
-reduction of pseudoarthrodesis
-loosening of pedicle screws
-improvement of clinical symptoms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fusion rate
Rate of intervertebral disc narrowing and instability
Occurrence rate of screw loosening
Key secondary outcomes
ADL and QOL
femoral bone mineral density
bone metabolic markers
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
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teriparatide treatment (6 months)
Interventions/Control_2
Bisphosphonate treatment (6 months)
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are eligilble for multilevel spinal fusion surgery for having lumbar degenerative disease (lumbar degenerative spondylolisthesis, adult spinal deformity, spinal stenosis, spondylolytic
spondylolisthesis)
2. Patients 50 years of age or older at the time of signing consent form
3. Patients with osteoporosis at a high risk of fracture
Key exclusion criteria
1.The following patients are considered to be at high risk of developing osteosarcoma
(1)Patients with Paget's disease in the bone
(2)Patients with high alkaline phosphatase of unknown cause
(3)Patients with a history of radiotherapy which is likely to have affected the bone
2.Patients with hypercalcaemia(adjusted serum calcium level>=10.5mg/dL)
3.Patients with primary malignant osteosarcoma or metastatic bone tumor
4.Patients with metabolic bone diseases other than osteoporosis (hyperparathyroidism etc.).
5.Patients with a history of hypersensitivity to the constituents of teriparatide from subcutaneous injection.
6. Females who are pregnant or may be pregnant.
7.Patients with contraindication to bisphosphonate treatments.
8.Patients with a history of administration of denosumab or Forteo use.
9. Any other patients whom the attending physician investigator has determined to be unsuitable for the conduct of the study.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | 1.Hirotaka Haro 2. Yukihiro Matsuyama 3.Jun Takahashi |
Organization
1.University of Yamanashi
2.Hamamatsu University School of Medicine
3.Shinshu University, School of Medicine
Division name
1-3 Department of Orthopaedic Surgery
Zip code
Address
1.1110 Shimokato, Chuo, Yamanashi 409-3898, Japan 2.1-20-1 Handayama Hamamatsu Higashi-ku, Shizuoka431-3125 Japan 3.3-1-1 Asahi Matsumoto, Nagano 390-0802 Japan
TEL
055-273-6768
haro@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Haro |
Organization
University of Yamanashi
Division name
Department of Orthopaedic Surgery
Zip code
Address
1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL
055-273-6768
Homepage URL
haro@yamanashi.ac.jp
Sponsor or person
Institute
1.University of Yamanashi
2.Hamamatsu University School of Medicine
3.Shinshu University, School of Medicine
1-3Department of Orthopaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
ASAHI KASEI PHARMA Co., Medical Affairs
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fujiyoshida Municipal Hospital
Enshu Hospita
Hamamatsu Sekijuji Hospital
Iwata City Hospital
Jyuzen Memorial Hospital
Hamamatsu Medical Center
Narita Memorial Hospital
Shinonoi General Hospital
Azumi Hospital
Ina Central Hospital
Suwa sekijuji Hospital
Yamanashi Prefectural Central Hospital
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
| 2014 | Year | 09 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 18 | Day |
Last modified on
| 2016 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017674
| Research Plan | |
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| 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 |
