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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015202
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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&#39;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
Email 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
Email haro@yamanashi.ac.jp

Sponsor
Institute 1.University of Yamanashi
2.Hamamatsu University School of Medicine
3.Shinshu University, School of Medicine

1-3Department of Orthopaedic Surgery
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017674


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