The purpose of the present study is to compare the effects of Pamidronate and calcium-D on bone mineral density of renal transplant patients. The patients aged more than 18 years old of first or second living donor renal transplant in Isfahan renal transplantation centers, Khorshid & Alzahra hospitals, who haven’t received corticosteroid 3 months prior to RTx, hemodynamically stabe in 24 hours after RTx, without history of previous parathyroidectomy, and not treated with bisphosphonates any time before RTx, were randomly to receive Pamidronate 90mg (Amp) immediately after RTx and 3 months after plus Calcium- vit D ( 500 mg Ca and 400IU vit D) for 6 months or only Calcium- vit D for 6 months. Bone mineral density is measured before and 6 months after RTx.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903252417N2
Registration date:2010-09-07, 1389/06/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-07, 1389/06/16
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2006-01-01, 1384/10/11
Expected recruitment end date
2010-12-31, 1389/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of Pamidronate and calcium-D effect on bone mineral density of renal transplant patients in Isfahan
Public title
comparison of Pamidronate and calcium-D effect on bone mineral density of renal transplant patients in Isfahan
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: adult recipients more than 18 years of first or second living donor renal transplant in Isfahan renal transplantation centers.
Exclusion criteria: receiving corticosteroid 3 months prior to the renal transplantation (RTx), treating with bisphosphonates, Flouride or Calcitonin any time before RTx, hypercalcemia persisting during the first 2 weeks after RTx, history of previous parathyroidectomy, hemodynamic instability in 24 hours after RTx
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2007-04-10, 1386/01/21
Ethics committee reference number
83473
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
Bone mineral density
Timepoint
before and after intervention
Method of measurement
DEXA (dual energy x ray absorptiometry)
Secondary outcomes
empty
Intervention groups
1
Description
Pamidronate 90mg plus calcium-vitamin D immediately after and after 3 months from renal transplantation
Category
Treatment - Drugs
2
Description
Calcium-vitamin D (500mg calcium and 400 unit vitamine D)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Renal Transplantation Unit, Alzahra Hospital
Full name of responsible person
Dr Shahrzad Shahidi
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Renal Transplantation Unit, Khorshid Hospital
Full name of responsible person
Dr Shahrzad Shahidi
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Shahrzad Shahidi
Position
Associate Prof. Nephrology
Other areas of specialty/work
Street address
Internal Medicine Unit, School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1663 6858
Fax
Email
shahidi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Shahrzad Shahidi
Position
Associate Prof. in Nephrology
Other areas of specialty/work
Street address
Internal Medicine Unit, School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1663 6858
Fax
Email
shahidi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Firouzeh Moeinzadeh
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Department of Nephrology, Khorshid Hospital
City
Isfahan
Postal code
Phone
+98 31 1628 3356
Fax
Email
moinzade@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)