Evaluation and comparison of the degree of change in the severity of osteopenia after six months in patients before and after taking alendronate
Design
A single arm, non-blind, nonrandomized, phase 2 clinical trial on 30 patients.
Settings and conduct
30 patients with acute leukemia referred to Tabriz Children's Educational and Medical Center are randomly selected. Alendronate will be given for 6 months. They will receive daily calcium syrup and vitamin D 50,000 IU N tablets every two weeks. Bone mineral density, blood levels of vitamin D and calcium, phosphorus and alkaline phosphatase will be measured and their changes will be compared after six months of administration.
Participants/Inclusion and exclusion criteria
30 children under 15 years of age with acute lymphoblastic or myeloblastic leukemia referred to Tabriz Children Hospital. Children with chronic leukemia and under 2 years old will not be included in the study.
Intervention groups
Alendronate group: 30 children with acute leukemia will be given alendronate for six months.
The Evaluation of The effects of Alendronates on Osteopenia in Children with Acute Leukemia
Public title
The Effect of Alendronate in the Treatment of Osteopenia due to Acute Leukemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children under 15 years
Children with acute lymphoblastic leukemia
Children with acute myeloblastic leukemia
Exclusion criteria:
Children with chronic leukemia
Children under 2 years
Age
From 2 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
1
Two blood samples before and after the medication
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research Vice-Chancellor, 3rd floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5154300633
Approval date
2020-03-02, 1398/12/12
Ethics committee reference number
IR.TBZMED.REC.1398.1268
Health conditions studied
1
Description of health condition studied
Acute Lymphoblastic Leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
2
Description of health condition studied
Acute Myeloblastic Leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
Primary outcomes
1
Description
Serum level of vitamin D
Timepoint
Measurement of serum vitamin D levels at baseline (before intervention) and six months after Alendronate administration
Method of measurement
Enzyme-linked Immunosorbent assay (ELISA)
2
Description
Serum level of Calcium
Timepoint
Measurement of serum calcium levels at baseline (before intervention) and six months after Alendronate administration
Method of measurement
Biochemistry auto-analyzer
3
Description
Serum level of Phosphorus
Timepoint
Measurement of serum phosphorus levels at baseline (before intervention) and six months after Alendronate administration
Method of measurement
Biochemistry auto-analyzer
4
Description
Bone density
Timepoint
Bone density evaluation at baseline (before intervention) and six months after Alendronate administration
Method of measurement
Dual Energy X-ray Absorptiometry (DEXA)
5
Description
Serum Alkaline Phosphatase levels
Timepoint
Measurement of serum alkaline phosphatase levels at the beginning of the study (before the intervention) and six months after the use of alendronate
Method of measurement
Biochemistry auto-analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 patients with acute leukemia for six months alendronate with the chemical composition of alendronate sodium, tablets with a concentration of 70 mg, with a dose of 35 mg once a week or 5 mg once daily orally, company Hashtgerd Iran Pharmacy will be prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Laleh Tokhmechian
Street address
Tabriz Children Hospital, Sheshgelan Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
dr.tokhmechian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Research Vice-Chancellor, 3rd floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5154300633
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Laleh tokhmechian
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Tabriz Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
dr.tokhmechian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Laleh tokhmechian
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Tabriz Children Hospital, Sheshgelan Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
dr.tokhmechian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Laleh Tokhmechian
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children Hospital, Sheshgelan Street.Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
dr.tokhmechian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All personal data of the study participants can be shared after the individuals are not identified. The study protocol will be published after its completion and the clinical study report will be available.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
The data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of data including demographic characteristics and blood test results and DEXA scan will be allowed in clinical trial and meta-analysis studies.
From where data/document is obtainable
Laleh Tokhmechian
dr.tokhmechian@yahoo.com
What processes are involved for a request to access data/document
Personal details including name and surname, place of work, place of study should be provided.
Type of study, sample size, study objectives, place of study should also be mentioned.
After completing the study and printing the results, the data will be presented as an article.