The aim of this study was to evaluate the results of postoperative alendronitis in patients with lumbar vertebral fracture without surgical signs.
Design
Parallel group randomised trial without blinded group
Settings and conduct
The present study will be carried out at Imam Reza Hospital in Tabriz, Iran, in the Department of Neurosurgery. Blind will not be done. Patients in the intervention group will receive Alendronate, and patients in the control group will receive the necessary supportive measures.
Participants/Inclusion and exclusion criteria
This study was a randomized clinical trial on 60 patients with thoracolumbar vertebral fractures due to spinal trauma referring to Tabriz Imam ًReza Hospital without the indication of fusion surgery in the vertebral column. All patients will undergo a neurological assessment of neurological outcome while receiving initial treatments for trauma and standard treatments (NSAIDs and painkillers) and medical emergencies. Patients will be divided into random groups A and B by Randlist 2.1 software. Group A will receive Alendronate and Group B will receive analgesics. Group A patients will receive weekly 35 mg alendronate at a dose of 70 mg per week after discharge. Patients will not be deprived of standard treatment (NSAIDs, relief and other needed).
Intervention groups
Patients in the intervention group will receive weekly 35 mg of alendronate at a dose of 70 mg per week after discharge.
Main outcome variables
Patients with low back pain will be evaluated on the basis of the Visual Analogue Scale 6 months after receiving the drug.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101122005230N3
Registration date:2019-07-28, 1398/05/06
Registration timing:retrospective
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
Moslem Shakery
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 7927
Email address
shakerym@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-26, 1398/04/05
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Results of alendronate administration in patients with lumbar spine fracture without surgical indication
Public title
Alendronate effects in patients with lumbar spine fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of Indication for Surgery based on Thoracolumbar injury classification severity score
Spinal cord fracture according to Denis model in CT Scan
Informed consent to participate in the study
Exclusion criteria:
Pathological fractures
Fractures in several vertebrae
Simultaneous head trauma and neurological status of the patient in such a way that it is not possible to have a neurological examination at the time of admission
Neural failure before spinal trauma
Fracture-type fracture-dislocation
Disturbed results of calcium and serum vitamin D tests (osteoporosis)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into random groups A and B by Randlist 2.1 software. Group A will receive Alendronate and Group B Hemorrhage. Patients will be followed up for 6 months.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences