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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 30 April 2018
Main ID:  ISRCTN33207390
Date of registration: 12/10/2006
Prospective Registration: Yes
Primary sponsor: Institut de Recherches Internationales Servier (France)
Public title: Long-term effects of strontium ranelate on knee osteoarthritis symptoms: a two year prospective, randomised, placebo-controlled study
Scientific title: Long-term effects of strontium ranelate on knee osteoarthritis symptoms. A 2-year prospective, randomised, placebo-controlled study.
Date of first enrolment: 30/11/2006
Target sample size: 140
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN33207390
Study type:  Interventional
Study design:  Randomised, double-blind, parallel-group, placebo-controlled trial (Treatment)  
Phase:  Not Specified
Countries of recruitment
Belgium
Contacts
Name: JY    Reginster
Address:  Policlinique Brull, 45 Quai Godefroid Kurth 4020 Liège Belgium
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Caucasian males or females
2. Aged 45 years or over
3. Primary knee osteoarthritis
4. Under an effective contraceptive method for non-menopausal women

Exclusion criteria: 1. Knee prosthesis already implanted, or foreseen to be implanted
2. Hip prosthesis already implanted or not well-tolerated or foreseen to be implanted
3. Previous osteotomy on the inferior limbs


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Osteoarthritis
Musculoskeletal Diseases
Arthrosis
Intervention(s)
Strontium ranelate versus placebo.
Primary Outcome(s)
Changes in the algofunctional behaviour of the target knee.
Secondary Outcome(s)
1. Algofunctional assessment
2. Radiographic assessment of knee osteoarthritis
3. Physical examination
Secondary ID(s)
CL3-12911-028
Source(s) of Monetary Support
Institut de Recherches Internationales Servier (France)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Ethics Committee approval obtained on 07/09/2006 (n° 154): Comité d?Ethique Hospitalo-Facultaire Universitaire de Liège.
Results
Results available: Yes
Date Posted:
Date Completed: 30/12/2009
URL:
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