Determining the effects of alendronate on the function and pain in patients with knee osteoarthritis referred to Rafsanjan Rheumatology Clinic in 2021
Design
A clinical trial with a control group, with parallel groups, randomized, phase 3 on 80 patients, for randomization a random number table was used.
Settings and conduct
Clinical trial will be performed in 2023 on osteoarthritis patients referred to the Rheumatology Clinic of Rafsanjan. Patients will be evaluated at the beginning of the study and one and two months after the intervention using the Visual Analogue Scale (VAS) and the WOMAC index.
Participants/Inclusion and exclusion criteria
Age 45-70 years, the diagnosis of osteoarthritis is based on the criteria of the American College of Rheumatology, which is confirmed by a rheumatology specialist.
Exclusion:Patients suffering from inflammatory diseases
Cancer with serious diseases of liver or kidney failure, Oral corticosteroid use in the last 4 weeks, Cortisone injection in the last 6 months, Fever, Consuming medicinal plants, Unwillingness to continue participating in the study, Consuming painkillers on a regular daily basis.
Intervention groups
Participants will be divided into two groups: Group 1 (40 people) using using alendronate.Group 2 (40 people) placebo.
Main outcome variables
Pain and status of osteoarthritis range of motion, morning dryness and physical function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040759N5
Registration date:2023-10-24, 1402/08/02
Registration timing:registered_while_recruiting
Last update:2023-10-24, 1402/08/02
Update count:0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Mitra Abbasifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0040
Email address
dr.mabbasifard@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of alendronate on the function and pain in patients with knee osteoarthritis referred to Rheumatology Clinic
Public title
The effects of alendronate on the function and pain in patients with knee osteoarthritis referred to Rheumatology Clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45-70 years
The diagnosis of osteoarthritis of the knee according to the criteria of the American College of Rheumatology, which is confirmed by a specialist in hematology
Exclusion criteria:
Patients suffering from inflammatory diseases (such as lupus, rheumatoid arthritis, history of brucellosis, etc.)
Cancer with serious diseases
Symptoms with a history of liver or kidney failure
Oral corticosteroid use in the last 4 weeks
Cortisone injection in the last 6 months
Fever
Consuming medicinal plants continuously
Unwillingness to continue participating in the study
Use of dietary and medicinal supplements
Consuming painkillers on a regular daily basis and very advanced disease
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method. Unit: individual, simple randomization tool: first, stewartritis patients were randomly selected from among the clients to the clinic according to clinical evidence and randomly divided into two groups: control group and alendronate group without regard to gender. It should be noted that there were 40 people in the control group and 40 people in the Alendronite group.people.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2021-04-05, 1400/01/16
Ethics committee reference number
IR.RUMS.REC.1400.161
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee pain intensity
Timepoint
At the beginning and the end of the study (two months after the beginning of the study)
Method of measurement
Visual Analogue Scale (VAS) And WOMAC index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1 (40 people) will use alendronite. The duration of treatment will be 2 months, 70 mg will be administered orally weekly.
Category
Treatment - Drugs
2
Description
Control group: Group 2 (Placebo) (40 individuals). The form and type of the drug is the same. The treatment duration is 2 months, 70 mg will be administered orally weekly.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic of Rafsanjan University of Medical Sciences
Full name of responsible person
Mahsa Hassanipour
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
mahsahasanipour@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Central Organization of Rafsanjan University of Medical Sciences. Imam Ali Avenue,
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Fax
+98 34 3428 0097
Email
rvazirinejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Mahsa Hassanipour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pharmacology
Street address
Central Organization of Rafsanjan University of Medical Sciences. Imam Ali Avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0040
Email
mahsahasanipour@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mahsa Hassanipour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pharmacology
Street address
Central Organization of Rafsanjan University of Medical Sciences. Imam Ali Avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0040
Email
mahsahasanipour@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mahsa Hassanipour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pharmacology
Street address
Central Organization of Rafsanjan University of Medical Sciences. Imam Ali Avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0040
Email
mahsahasanipour@rums.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