Effect of Alendronate on Bone Densitometry in Osteoporetic Chronic Kidney Disease Stage 3a-3b
Design
Clinical Trial with Control Group, was Double Blinded Through Patients’, Assessor and Analyzer Blinding on 82 Osteoporosis Patients with Chronic Kidney Disease, 41 in Control Group and 41 in Intervention Group by Final Allocation Method.
Settings and conduct
The study will be carried out in Nephrology section of Imam Khomeini Hospital of Ahvaz. Blinding is done in the way that in order to Reduce the likelihood of Bias in information, Patients, Assessor, Analyzer, the Results, the Type of Treatment Assigned to each Patient and the Groups Including Patients will be Kept in Secret
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Osteoporotic Patients over 18 years of Age with Chronic Kidney Disease stage 3a-3b
Exclusion Criteria: Patients who Suffer From Hyperparathyroidism, Hypoparathyroidism or Normal Densitometry at The same Time are Excluded.
Intervention groups
Osteoporic Patients over 18 Years of Age with Chronic Kidney Disease of Stage 3a-3b are Divided into the Intervention and Control Groups by Random Final Allocation Method using a Six-Block Test. Patients in the Main Group Receive Alendronate 70 mg Per Week in a Single dose Before Breakfast for 6 months. Patients in the Control Group also Receive Placebo once a Week in a Single dose, Before Breakfast and for 6 Months. The placebo in Terms of its Appearance, Size, Taste and Color is Similar to That of The Original Group.
Main outcome variables
Bone Density
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180506039549N1
Registration date:2018-10-22, 1397/07/30
Registration timing:retrospective
Last update:2018-10-22, 1397/07/30
Update count:0
Registration date
2018-10-22, 1397/07/30
Registrant information
Name
benyamin masmou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5283 0763
Email address
masmou.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-09-11, 1397/06/20
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2017-12-16, 1396/09/25
Trial completion date
empty
Scientific title
Effect of Alendronate on Bone Densitometry in Osteoporetic Chronic Kidney Disease Stage 3a-3b
Public title
Effect of Alendronate in Patents with Osteoporosis and Chronic Kidney Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Osteoporotic Patients with Chronic Kidney Disease
Patients over 18 years of Age
Exclusion criteria:
Patients with hyperparathyroidism
Patients with hypoparathyroidism
Patients with normal Densitometry
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
82
Actual sample size reached:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization With Using Six Blocks, One Group Including Intervention and another Group is Placebo, and Patients Selected Randomly According to The Blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
To reduce the risk of bias, patient and assessor and statistician were blinded to know the type of treatment assigned to each person and that which patient was in which group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan St , Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-08-04, 1397/05/13
Ethics committee reference number
IR.AJUMS.REC.1397.369
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease Stage 3a-3b
ICD-10 code
N18.3
ICD-10 code description
Chronic kidney disease, stage 3 (moderate)
Primary outcomes
1
Description
Bone density in patients with Chronic Kidney Disease Stage 3a-3b
Timepoint
Before and 6 months after study
Method of measurement
Densitometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Alendronate 70mg Tablet Produced by Abidi Company Will Orally be Administered to This Group once a Week Before Meals, with a Glass of Water for 6 Months.
Category
Treatment - Drugs
2
Description
Control group: Placebo is Administered to This Group in the Form of Pills with The same dose and Duration as The Intervention Group.The Placebo will be Produced at the Faculty of Pharmacy, Jundishapur University of Medical Sciences, Ahvaz, and its Appearance, Size, Taste and Color are similar to those of the main Group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology ward of Emam Khomeini hospital of Ahwaz
Full name of responsible person
Shokouh Shayanpour
Street address
Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
shayanpour-sh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Majid Karandish
Street address
Golestan St , Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-12794
Phone
+98 61 3333 7077
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan St , Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-12794
Phone
+98 61 3333 7077
Email
shayanpor.sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan St , Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-12794
Phone
+98 61 3333 7077
Email
shayanpour.sh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan , St
City
Ahvaz
Province
Khouzestan
Postal code
61357-12794
Phone
+98 61 3333 7077
Email
shayanpour.sh@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available