UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044337 |
|---|---|
| Receipt number | R000050639 |
| Scientific Title | A prospective randomized study on the incidence of postoperative Proximal junctional fracture(PJF) in patients undergoing spinal deformity surgery according to osteoporosis drugs |
| Date of disclosure of the study information | 2021/05/26 |
| Last modified on | 2023/05/29 19:22:32 |
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Basic information
Public title
A prospective randomized study on the incidence of postoperative Proximal junctional fracture(PJF) in patients undergoing spinal deformity surgery according to osteoporosis drugs
Acronym
A prospective study on PJF incidence according to osteoporosis drugs in patients with spinal deformity
Scientific Title
A prospective randomized study on the incidence of postoperative Proximal junctional fracture(PJF) in patients undergoing spinal deformity surgery according to osteoporosis drugs
Scientific Title:Acronym
A prospective study on PJF incidence according to osteoporosis drugs in patients with spinal deformity
Region
| Japan |
Condition
Condition
Adult spinal deformity surgery
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether teriparatide treatment can reduce the incidence of postoperative fixed upper vertebral body fractures (PJF) in spine deformity surgery patients with osteoporosis, compared with the usual treatment for osteoporosis, such as bisphosphonates and vitamin D agents. The purpose of this study is to investigate whether the use of bisphosphonates and vitamin D drugs can reduce PJF.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence and duration of PJF during the first postoperative year.
Key secondary outcomes
Re-operation by PJF, Health-related QOL,
Change in bone mineral density during the observation period, and adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the Department of Orthopaedic Surgery, Hamamatsu University School of Medicine, patients who are scheduled to undergo spinal deformity surgery and have osteoporosis will be randomly assigned to receive teriparatide or bisphosphonate as osteoporosis medication. Medication will be started 1-6 months preoperatively, and the occurrence of PJF within 1 year postoperatively will be investigated.
The teriparatide group is administered a subcutaneous injection of 28.2 mg of Teribone once a day, twice a week.
Interventions/Control_2
For the bisphosphonate group, RECALBON tablet 50 mg is orally administered once every four weeks at the time of waking.
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age at the time of surgery must be 18 years or older
2. Able to walk or use a cane
3. Patients with T-score < -2.5 SD at either femur or lumbar spine by DEXA bone mineral density measurement. Patients with a history of proximal femur fracture or vertebral fracture. Patients with other fragility fractures (distal radius fracture, proximal humerus fracture, pelvis fracture, rib fracture, tibia fracture) with a T-score < -1.0 SD. The definition of a fragility fracture is a non-traumatic fracture caused by a minor external force. The definition of a fragility fracture is a non-traumatic fracture caused by a minor external force. A minor external force is a fall from a standing position or a lesser external force.
4. Research subjects who have given written consent in person (or in the case of minors, by themselves and their guardians).
Key exclusion criteria
1. Patients with neuromuscular diseases such as Parkinson's disease
2. Patients with syndromic scoliosis
3. Patients who have undergone surgery for spinal deformity due to infection or tumor.
4. Patients who are deemed inappropriate by the doctor in charge.
5. women who are pregnant or who wish to become pregnant
6. Patients who have already been treated with teriparatide for osteoporosis
7.Patients for whom teriparatide is contraindicated (Paget's disease of bone, unexplained high ALP levels, radiotherapy with possible effect on bone, hyper caemia, metabolic bone diseases other than osteoporosis)
8.Patients with contraindications to bisphosphonates (severe renal failure, esophageal achalasia, hypocalcemia, hypersensitivity to bisphosphonates)
9. Patients who have received Denosumab subcutaneous injection 60 mg within 6 months of obtaining consent, or Zoledronic Acid Hydrate intravenous solution 5 mg within 1 year of obtaining consent.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Oe |
Organization
Hamamatsu Medical University of School
Division name
Geriatric musculoskeletal Health
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku Hamamatsu city
TEL
0534352299
daisuketogawa@wish.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Nakai |
Organization
Hamamatsu University School of Medicine
Division name
Orthopedics Surgery
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku Hamamatsu city
TEL
0534352299
Homepage URL
k134nakai@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama Higashi-ku Hamamatsu city
Tel
0534352299
mecersior@gmail.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
| 2021 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050639
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