the Aim of this study is to Evaluate the intravenous pamidronate and oral alendronate on bone marrow density in patients with major and intermedia thalassemia in Amirkabir hospital. this study is clinical trials in patients with major and inter media thalassemia with age more than 10 years referred to Amir kabir hospital.We will divide patients into two groups(each group 20 person).We evaluate bone density of the spine and neck of the femur in patients.We prescribe 70 milligram Alendronate once a week in A group. We prescribe 0.5 milligram per kilogram of Pamidronate IV in day for three days in B group. If the calcium is above 8 milligram in milliliter , the drug is injected into the patient.We follow up patients for one years.We evaluate bone density of the spine and neck of the femur and record the improvement of patient's clinical symptoms .Inclusion criteria: patients with major and inter media thalassemia with age more than 10 years referred to Amir kabir hospital. Exclusion criteria: Gastrointestinal intolerance for oral medication; having allergic drug reaction ; heart failure; liver failure; hypoparathyroidism
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070420258N51
Registration date:2017-07-16, 1396/04/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-16, 1396/04/25
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor and Research,Arak University of Medical Sciences
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intravenous pamidronate & oral alendronate on bone marrow density in patients with major and intermedia thalassemia
Public title
Evaluation of intravenous pamidronate & oral alendronate on bone marrow density in patients with major and intermedia thalassemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with major and inter media thalassemia ,age more than 10 years referred to Amir kabir hospital
Exclusion criteria: Gastrointestinal intolerance for oral medication; having an allergic drug; heart failure; liver failure; hypoparathyroidism
Age
From 10 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2017-02-06, 1395/11/18
Ethics committee reference number
IR.ARAKMU.REC.1395.383
Health conditions studied
1
Description of health condition studied
major and inter media thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Spinal bone density and femoral neck
Timepoint
End of one years
Method of measurement
X-ray photography
2
Description
Improve the status of clinical symptoms
Timepoint
End of one years
Method of measurement
clinical observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We prescribe 70 milligram Alendronate once a week in A group.
Category
Treatment - Drugs
2
Description
Intervention group: We prescribe 0.5 milligram in kilogram of Pamidronate IV in day for three day in B group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr Fatahibayat
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences