The aim of our study was to investigate the potential effect of Alendronate on the symptoms of knee osteoarthritis. A total number of 39 Patients with primary knee osteoarthritis were enrolled in a randomized double-blined placebo controlled trial and assigned to intervention or placebo group to receive Alendronate 7o milligram pills (Alendronate product of Dr. ABIDI Company), one tablet per week orally or placebo for 24 weeks. The Primary outcome was Knee ostoarthritis symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803271479N2
Registration date:2009-09-03, 1388/06/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-03, 1388/06/12
Registrant information
Name
Mohammadhassan Jokar
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 8818
Email address
jokarmh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Science
Expected recruitment start date
2007-12-22, 1386/10/01
Expected recruitment end date
2008-12-20, 1387/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Alendronate on symptoms of knee osteoarthritis
Public title
The effect of Alendronate on symptoms of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: fulfilling the American College of rheumatology (ACR) criteria of primary knee osteoarthritis, radiologically ascertained grade I or II severity of OA of the knee on the Kellgren-Lawrence scale, having a Western Ontario and McMaster Universities (WOMAC) pain subscale index of at least 2 at baseline (the 5-point Linkert version of the WOMAC), presence of daily knee pain for at least 6 months preceding the study
Exclusion criteria: Presence of secondary osteoarthritis, arthroscopy or surgery of target knee within 6 months prior to study, intra-articular treatment of target knee within 6 months prior to study, other chronic inflammatory processes, previous gastrointestinal problems (such as gastroesophageal reflux or esophageal stricture), previous allergic reactions to bisphosphonates, presence of any risk factors for osteoporosis
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Mashhad University of Medical science
Street address
Mashhad University of Medical science, Daneshgah Street
City
Mashdad
Postal code
Approval date
empty
Ethics committee reference number
86654
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis
Primary outcomes
1
Description
Reduction in symptoms of knee osteoarthritis
Timepoint
Weeks 0, 4, 12, 24
Method of measurement
WOMAC Index
Secondary outcomes
1
Description
Joint space narrowing
Timepoint
weeks 0 and 24
Method of measurement
Knee X-ray
Intervention groups
1
Description
Alendronate tablet 70mg orally single dose/week (Alnate product of Dr. Abidi Company) for 24 weeks.
Category
empty
2
Description
Placebo, one tablet orally per week for 24 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammadhassan Jokar
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Mahiar Mirheidari
Street address
Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Science
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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadhassan Jokar
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1859 8818
Fax
+98 51 1859 8818
Email
jokarmh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadhassan Jokar
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1859 8818
Fax
+98 51 1859 8818
Email
jokarmh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)