Determining the effectiveness of prolia drug usage on bone density in hemodialysis patients
Design
Clinical trials have an intervention group, non-blinding, non-random, phase 3 in 120 patients
Settings and conduct
This clinical trial will be performed to determine the effectiveness of the prolia drug on the bone density of hemodialysis patients. Hemodialysis patients referred to Alborz clinic, after bone density testing, if confirmed by osteoporosis by a physician and conscious consent, intervened and received a 60 mg dose of prolia (Denosumab) subcutaneously. People will return after a month and have a bone density test again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the patient has a medical diagnosis of osteoporosis; undergoing hemodialysis courses. Exclusion criteria: previous history of fracture; the patient does not have osteoporosis.
Intervention groups
After performing a bone density test and assuring osteoporosis, the person will receive a 60 mg dose of prolia (Denosumab) subcutaneously. One month after the injection, the person will have a bone resuscitation test and the effectiveness of the prolia will be checked.
Main outcome variables
Bone density
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191030045282N1
Registration date:2020-06-12, 1399/03/23
Registration timing:registered_while_recruiting
Last update:2020-06-12, 1399/03/23
Update count:0
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Elahe Dolatshahi
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 0030
Email address
e.dolatshahi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of using Prolia drug on bone density in hemodialysis patients
Public title
The effectiveness of using Prolia drug on bone density
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient should have informed consent to participate in the intervention
The patient should be undergone hemodialysis courses
The patient has a medical diagnosis of osteoporosis
Exclusion criteria:
The patient does not have conscious consent to participate in the intervention
The patient does not have a medical diagnosis of osteoporosis
The patient has a history of previous fractures
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
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 Alborz University of Medical Sciences
Street address
Deputy of research and technology, Safarian Ave., Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2020-03-08, 1398/12/18
Ethics committee reference number
IR.ABZUMS.REC.1398.151
Health conditions studied
1
Description of health condition studied
Bone density
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bone density
Timepoint
The amount of bone density will be measured before the intervention and one month after the subcutaneous injection of the prolia drug.
Method of measurement
Bone density measurement test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These people will intervene after a bone density measurement test and confirmation of osteoporosis, if there is conscious consent,Individuals receive subcutaneous doses of 60 mg of prolia (Denosumab).one month after the injection, people will return and have a bone density test again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz Subspecialty Clinic
Full name of responsible person
Elahe Dolatshahipirooz
Street address
Mahdiye Ave,Tohid Sq
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3221 0484
Email
e.dolatshahi@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology of Alborz university of medical sciences
Full name of responsible person
Mohammad Noorisepehr
Street address
Safarian Ave ,Golshahr,Deputy of research and technology
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
e.dolatshahi@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology of Alborz university of medical sciences