Main
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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:
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ISRCTN |
Last refreshed on:
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30 April 2018 |
Main ID: |
ISRCTN33207390 |
Date of registration:
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12/10/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Long-term effects of strontium ranelate on knee osteoarthritis symptoms: a two year prospective, randomised, placebo-controlled study
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Scientific title:
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Long-term effects of strontium ranelate on knee osteoarthritis symptoms. A 2-year prospective, randomised, placebo-controlled study.
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Date of first enrolment:
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30/11/2006 |
Target sample size:
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140 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN33207390 |
Study type:
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Interventional |
Study design:
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Randomised, double-blind, parallel-group, placebo-controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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Belgium
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Contacts
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Name:
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JY
Reginster |
Address:
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Policlinique Brull, 45 Quai Godefroid Kurth
4020
Liège
Belgium |
Telephone:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Osteoarthritis Musculoskeletal Diseases Arthrosis
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Intervention(s)
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Strontium ranelate versus placebo.
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Primary Outcome(s)
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Changes in the algofunctional behaviour of the target knee.
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Secondary Outcome(s)
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1. Algofunctional assessment 2. Radiographic assessment of knee osteoarthritis 3. Physical examination
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Secondary ID(s)
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CL3-12911-028
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
Ethics Committee approval obtained on 07/09/2006 (n° 154): Comité d?Ethique Hospitalo-Facultaire Universitaire de Liège.
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/12/2009 |
URL:
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