The goal of this study is evaluation of the effect of intravenous Pamidronate on rheumatoid arthritis disease activity (DAS28 score). The study population includes patients referred to the Rheumatology Clinic of Alzahra Hospital. Sample size in this study is 37 people. The intervention under study is infusion of 60 mg Pamidronate intravenously each month for three months. Study starts at the fall 2009 and continues until winter 2011. The primary endpoint is improvement of clinical symptoms and laboratory parameters of patients who have injected Pamidronate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138801051778N1
Registration date:2010-04-06, 1389/01/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-04-06, 1389/01/17
Registrant information
Name
Mansour Salesi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1265 1983
Email address
salesi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery of research, Isfahan University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluatoin of intravenous pamidronate effect on disease activity in patients with rheumatoid arthritis
Public title
Pamidronate and disease activity in rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Rheumatoid arthritis patients who don’t have enough clinical and laboratory response to conventional disease modifying anti rheumatic drugs (DMARDs).
Exclusion criteria: patients who don’t want to have injection or had drug allergy or hypersensitivity, Drug reaction in the course of injection or after that, Lapse from study, Immigration or death.
Age
From 16 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
37
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
Isfahan University of Medical Sciences
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
8158697851
Approval date
2009-03-18, 1387/12/28
Ethics committee reference number
187074
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive rheumatoid arthritis
Primary outcomes
1
Description
Disease activity
Timepoint
Before of injection, every month until 3 months, then 6 months after first injection
Method of measurement
DAS28
Secondary outcomes
1
Description
Anti inflammatory effect of pamidronate
Timepoint
Before of injection, every month until 3 months, then 6 months after first injection.
Method of measurement
DAS28, ESR, VAS
Intervention groups
1
Description
Infusion of 60 mg Pamidronate intravenously each month for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mansour Salesi
Street address
Sofe Avenue
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery of research
Full name of responsible person
Dr Fallah
Street address
No#4 building, vice chancellery of 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
Vice chancellery of research
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
Mansour Salesi
Position
Rheumatologist/Assistant Professor
Other areas of specialty/work
Street address
Alzahra Hospital
City
Isfahan
Postal code
8158697851
Phone
+98 31 1265 1983
Fax
Email
salesi@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
Mansour Salesi
Position
Rheumatologist/Assistant Professor
Other areas of specialty/work
Street address
Alzahra Hospital
City
Isfahan
Postal code
8158697851
Phone
+98 31 1265 1983
Fax
Email
salesi@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
Mansour Salesi
Position
Rheumatologist/Assistant Professor
Other areas of specialty/work
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
8158697851
Phone
+98 31 1265 1983
Fax
Email
salesi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)