Protocol summary

Summary
The objective of this study was to investigate the effect of Bisphosphonate on osteoporosis in patients undergone kidney transplantation. 40 candidates of kidney transplantation, aged more than 20 years old, with low bone mineral density (T-Score < -2) in spine, total femur, or femoral neck, regardless the cause of end stage renal disease, were randomly assigned to receive Pamidronate or Alendronate. Pamidronate was administered as 90 mg infusions at the beginning and after three months. Alendronate, 70 mg orally, was administrated weekly for 6 months. Drug administration began in the third week for both groups. Both groups received standard treatment protocol including Prednisolone, Cyclosporine, and Mycophenolate Mofetil. Bone mineral density was measured via dual-energy x-ray absorptiometry (DXA) by a trained technician with a single instrument at the beginning and 6 months later. Plasma level of Parathormone hormone (PTH) was assessed at the beginning and at the end of study. Plasma level of calcium, phosphorus, alkaline phosphatase, blood urea, creatinine, and cyclosporine were measured monthly.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804162109N1
Registration date: 2010-03-20, 1388/12/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-03-20, 1388/12/29
Registrant information
Name
Bita Omidvar
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1445 7205
Email address
bita.omidvar@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Science
Expected recruitment start date
2008-10-05, 1387/07/14
Expected recruitment end date
2009-01-04, 1387/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Pamidronate effect on bone mineral density of kidney transplant patients in comparison with Alendronate in the first 6 month after transplantation
Public title
Effect of bisphosphonate on osteoporosis in kidney transplant patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Kidney transplantation candidates, aged above 20 with low bone mineral density (T-Score < -2) in spine or total femur or femoral neck. Exclusion criteria: Inability to stay in upright position for 30 minute, History of hypersensitivity reaction, Hyperparathyroidism, Hyperthyroidism, Hypocalcemia, Hypercalcemia, GFR < 35 ml/min or creatinine > 3 mg/dL, Active peptic ulcer disease, Jaw avascular necrosis, Uveitis, History of fracture druring 2 years prior to the study, Achalasia, or delayed esophagus emptying
Age
From 20 years old to 70 years old
Gender
Both
Phase
4
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
Ahvaz Jundishapur University of Medical Sciences
Street address
P.O.box: 61537-15794, Ahvaz Jundishapur University of Medical Sciences, Shahr-e-daneshgahi
City
Ahvaz
Postal code
61537-15794
Approval date
2008-09-05, 1387/06/15
Ethics committee reference number
پ/820/2973

Health conditions studied

1

Description of health condition studied
kidney transplant patients with low bone mineral density
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status

Primary outcomes

1

Description
Bone mineral density
Timepoint
6 months
Method of measurement
Dual-energy X-ray absoptiometry

Secondary outcomes

1

Description
Glomerular Filtration Rate
Timepoint
Every month
Method of measurement
Cockcroft-Gault

2

Description
Serum Intact Parathormone hormone (iPTH)
Timepoint
Every 6 months
Method of measurement
Radioimmunoassay

3

Description
Blood level of Cyclosporine
Timepoint
Every month
Method of measurement
Radioimmunoassay

Intervention groups

1

Description
Pmidronate 90 mg infused in the third week of transplant and third month after the first dose
Category
Treatment - Drugs

2

Description
Alendronate 70 mg orally administered weekly for 6 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Bita Omidvar
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Bita Omidvar
Street address
Golestan hospital, Internal Medicine department office
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyed Javad Shariat Nabavi
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Golestan Hospital, Internal Medicine Department office
City
Ahvaz
Postal code
Phone
+98 61 1374 3013
Fax
Email
arashrad57@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Bita Omidvar
Position
Assistant Professor
Other areas of specialty/work
Street address
Golestan Hospital, Internal Medicine Department
City
Ahvaz
Postal code
Phone
+98 61 1374 3013
Fax
Email
bita.omidvar@ajums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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