The aim of this double blind clinical trial is to determine the preventive effect of alendronatein steroid- induced osteopenia in childhood ALL or NHL. In this study 30 children with ALL or NHL will selected purposefully and will randomized to receive 35 mg alendronate /week for 6 months or control group (without any effective treatment for osteopenia). Demographic information and medical history will recorded in all patients. BMD will be done and compared at first and after 6 months(at the end of the study)in both groups. Informed consent form is essential inclusion criteria and patients non-compliance with treatment will be excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202279155N1
Registration date:2012-03-24, 1391/01/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-24, 1391/01/05
Registrant information
Name
Afsane Akhondzadeh
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1223 5605
Email address
akhondzadeh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak university of medical sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of alendronate in prevention of steroid- induced osteopenia in childhood ALL and NHL
Public title
Evaluation of alendronate in prevention of steroid- induced osteopenia in childhood ALL and NHL
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: children with ALL or NHL; informed consent form
exclusion criteria: Patient or parents desire to leave the study; Non-compliance with treatment regimen
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Arak university of medical sciences
Street address
Arak university of medical sciences, Sardasht, Arak.
City
Arak
Postal code
Approval date
2011-09-11, 1390/06/20
Ethics committee reference number
90-114-9
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukaemia
ICD-10 code
C91
ICD-10 code description
Acute lymphoblastic leukaemia
2
Description of health condition studied
Non-Hodgkin lymphoma
ICD-10 code
C85.9
ICD-10 code description
Non-Hodgkin lymphoma, unspecified
3
Description of health condition studied
osteoprosis
ICD-10 code
M81.4
ICD-10 code description
Drug-induced osteoporosis
Primary outcomes
1
Description
BMD
Timepoint
0, 6months after drug administration
Method of measurement
Bone densitometery of neck of femur and spins
Secondary outcomes
1
Description
sever allergic reaction
Timepoint
every week
Method of measurement
history and physical examination
2
Description
gastro intestinl problems
Timepoint
every week
Method of measurement
history and physical examination
Intervention groups
1
Description
case: cap alenderonate 35 mg/ week for 6 months
Category
Treatment - Drugs
2
Description
control group: without treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir kabir hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Arak University of Medical Sciences
Full name of responsible person
Dr. Said Changizi Ashtiyani
Street address
Deputy of Reserch, Arak University of Medical Siences, Sardasht, Arak.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Scienses
Full name of responsible person
Dr. Afsane Akhondzadeh
Position
resident of pediatrics
Other areas of specialty/work
Street address
Amir kabir hospital, Parastar square, Arak.
City
Arak
Postal code
Phone
+98 86 1223 5605
Fax
Email
akhondzadeh@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Scienses
Full name of responsible person
Dr. Aziz Eghbali
Position
Assistant professor, sub specialist of pediatrics
Other areas of specialty/work
Street address
Amir kabir hospital, Parastar square, Arak.
City
Arak
Postal code
Phone
+98 86 1223 5605
Fax
Email
akhondzadeh@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Scienses
Full name of responsible person
Dr. akram esmaili
Position
Other areas of specialty/work
Street address
Arak University of Medical Scienses, Parastar square, Arak.
City
Arak
Postal code
Phone
Fax
Email
daesmaili@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)