The present study designed to evaluate the impact of pamidronate on the BMD of major beta-thalassemia patients to improve the quality of life in these individuals.
Design
Clinical trial without control group. With single group. Not blind .No instance of randomization. 20 patients
Settings and conduct
Transfusion-dependent major beta-thalassemia patients under follow-up and treatment in haematology-clinic will be enrolled in study .Bone mineral density of the lumbar vertebra and hip joint using dual X-Ray absorptiometry will be done. Z scores values <-2.5 will be treated with Pamidronate in the monthly dosages of 1 mg/kg over six months, intravenously. Bone mineral density will be measured again after 6 months.
Participants/Inclusion and exclusion criteria
Z-score < -2.5 in BMD, Ferritin level>1000 mg/dl, upwards of 10 blood infusions, >100cc/kg of blood infusion per year, and normal creatinine level and blood counts
Exclusion: included the positive history of bone-related disorders, leukemia or neoplastic disorders, gastrointestinal disorders, and chronic inflammatory diseases.
Intervention groups
Transfusion-dependent major beta-thalassemia patients under follow-up and treatment in haematology-clinic will be enrolled in study .Bone mineral density of the lumbar vertebra and hip joint using dual X-Ray absorptiometry will be done. Z scores values <-2.5 will be treated with Pamidronate in the monthly dosages of 1 mg/kg over six months, intravenously. Bone mineral density will be measured again after 6 months.
Main outcome variables
bone mineral densitometry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211008052698N1
Registration date:2021-10-29, 1400/08/07
Registration timing:retrospective
Last update:2021-10-29, 1400/08/07
Update count:0
Registration date
2021-10-29, 1400/08/07
Registrant information
Name
Farid Ghazizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3224 1967
Email address
ghazizadeh.f@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-16, 1400/05/25
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
2020-09-15, 1399/06/25
Actual recruitment end date
2021-09-16, 1400/06/25
Trial completion date
2021-10-17, 1400/07/25
Scientific title
Effect of low dose pamidronate in the treatment of thalassemia-induced osteoporosis
Public title
Treatment of thalassemia-induced osteoporosis with pamidronate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Z-score < -2.5 in Bone Mineral Densitometry
Ferritin level>1000 mg/dl
More than 10 blood infusions or More than 100 cc/kg of blood infusion per year
Normal creatinine level
Normal blood counts
Exclusion criteria:
The positive history of bone-related disorders
Leukemia or Neoplastic disorders
Gastrointestinal disorders
Chronic inflammatory diseases
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
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 urmia University of Medical Sciences
Street address
Emergency Alley,Resalat Boulevard,urmia city
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2015-09-21, 1394/06/30
Ethics committee reference number
IR.USBMSU.MSP.REC.13946.133900
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Bone mineral densitometry
Timepoint
Baseline , Six month later
Method of measurement
Dual X-Ray absorptiometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pamidronate , intravenously in the monthly dosages of 1 mg/kg over six month