Protocol summary

Study aim
Evaluation of the effect of Vitamin D and Alendronate on pseudoarthrosis of the lumbosacral vertebrae in patients undergoing posterior lumbar fusion surgery
Design
This study is a clinical trial with a blind and randomized parallel group design. Among the patients diagnosed with lumbar disc herniation, spinal canal stenosis, lumbar Listis was selected by 75 neurosurgeons and divided into three groups of 25: fusion, fusion and andronate, fusion and vitamin D by blocking method (method of randomization).
Settings and conduct
This study among patients requiring laminectomy and lumbar vertebral fusion with the pedicure screw is performed up to 5 vertebral surfaces, referring to Imam Sari Hospital. The study is single blind and the radiologist interprets the patient's CT stereotype without knowing the clinical picture and how to be in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: lumbar discopathic patients, spinal canal stenosis, lumbar listhesis, Cr <1.2, patients between 20 and 65 years of age. Non inclusion criteria: patients with traumatic lesions, neoplastic lesions, infectious lesions, surgical history, diabetes, disabling underlying problems and rheumatic diseases, patients with a history of osteoarthritis and vitamin D deficiency less than 10 units, patients with renal insufficiency and GFR below 40.
Intervention groups
Intervention group 1: Patients in the alendronate group were given 70 mg of oral alendronate once every 6 weeks after surgery for 6 months. Intervention group 2: they received 50,000 units of vitamin D per month for six months. Control group: Patients in the control group received routine treatment after surgery
Main outcome variables
Pain; vertebral fusion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180826040869N2
Registration date: 2020-05-04, 1399/02/15
Registration timing: retrospective

Last update: 2020-05-04, 1399/02/15
Update count: 0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Misagh Shafizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
mi.shafizad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2020-01-31, 1398/11/11
Actual recruitment start date
2019-06-05, 1398/03/15
Actual recruitment end date
2020-03-15, 1398/12/25
Trial completion date
2020-03-18, 1398/12/28
Scientific title
Comparison of the effects of Alendronate and Vitamin D administration on lumbosacral vertebral fusion in patients undergoing posterior spinal cord fusion
Public title
Comparison of the effects of Alendronate and Vitamin D administration on lumbosacral vertebral fusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lumbar discopathy patients spinal canal stenosis lumbar Listis Cr <1.2 age between 20 and 65 years
Exclusion criteria:
Patients with traumatic lesions Neoplastic lesions Infectious lesions Surgical history Disabling underlying problems and rheumatic diseases Patients with a history of osteoarthritis and vitamin D deficiency less than 10 units Patients with renal insufficiency and GFR below 40
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 75
Actual sample size reached: 75
Randomization (investigator's opinion)
Randomized
Randomization description
75 people were selected and divided into three groups of 25: fusion, fusion and alendronate, fusion and vitamin D by blocking method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The radiologist interpreted the patient's CT scan radiographs without knowing the clinical picture and how to be in the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sari Imam Hospital, Mazandaran University of Medical Sciences
Street address
Imam Hospital, Amirmazandarani boulevard
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2019-05-01, 1398/02/11
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.018

Health conditions studied

1

Description of health condition studied
spinal fusion
ICD-10 code
M99.3
ICD-10 code description
Osseous stenosis of neural canal

Primary outcomes

1

Description
Percentage of people with no fusion
Timepoint
Patients will be re-examined and fusion of the vertebrae one month, three months, and six months after surgery
Method of measurement
Check CT scan stereotype

2

Description
Percentage of people with low pain scores
Timepoint
Patients will be re-examined for pain severity one month, three months, and six months after surgery
Method of measurement
From the visual analog scale vas (visual Analog Scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In the Alendronate group, 70 mg of oral Alendronate was given as treatment every 6 weeks for 6 months.
Category
Treatment - Drugs

2

Description
Intervention group 2: Patients received 50,000,000 units of vitamin D per month for six months. In addition to the present treatments, physiotherapy and supportive therapies were also performed.
Category
Treatment - Drugs

3

Description
Control group: Control group: Patients in this group receive conventional treatment
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Sari Hospital
Full name of responsible person
Misagh Shafizad
Street address
Amir Mazandarani Blvd ,Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Moalem Blvd., Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷-۳۳۹۷۱
Phone
+98 11 3448 4854
Fax
+98 11 3335 2725
Email
saedi@domian.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Misagh Shafizad
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandrani Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Misagh Shafizad
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Blvd ,Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mi.shafizad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Misagh Shafizad
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Amir Mazandarani Blvd, Sari
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+9833361700
Email
mi.shafizad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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