Condition category
Musculoskeletal Diseases
Date applied
05/05/2006
Date assigned
13/06/2006
Last edited
15/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Cyrus Cooper

ORCID ID

Contact details

University of Southampton
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

2005-002494-75

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-018

Study information

Scientific title

Acronym

Study hypothesis

To demonstrate the superiority of strontium ranelate versus placebo against articular cartilage damage progression over three years in men and women with knee osteoarthritis

Please note, as of 01/03/2011 the following updates have been made to this record:
1. The anticipated end date for this trial has been moved from 15/04/2009 to 30/03/2011
2. The public title has been updated. The previous title was 'The efficacy and safety of two doses of strontium ranelate versus placebo, administered orally for two years in the treatment of knee osteoarthritis. A prospective multicentre, international, double-blind, placebo-controlled study'.
3. The study hypothesis has been updated. The previous hypothesis was 'To demonstrate the superiority of strontium ranelate versus placebo against articular cartilage damage progression over two years in men and women with knee osteoarthritis'.
4. The target number of participants has been increased from 960 to 1680.

Ethics approval

First ethics committee approval given by the Ethical Committee of the Ospitalieri Institute of Verona on 14/12/2005, reference number: 1260)

Study design

Prospective multicentre international double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Osteoarthritis

Intervention

Strontium ranelate versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Strontium ranelate

Primary outcome measures

Radiographic assessment of knee osteoarthritis

Secondary outcome measures

1. Algofunctional assessment
2. Physical examination
3. Safety

Overall trial start date

15/04/2006

Overall trial end date

30/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Caucasian men and women of at least 50 years of age
2. Primary knee osteoarthritis
3. Under effective contraceptive method for non-menopausal women

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Added 01/03/2011: 1680 (960 at time of registration)

Participant exclusion criteria

1. Knee prosthesis already implanted or foreseen within the next year
2. Hip prosthesis recently implanted (<1 year) or not well-tolerated, or foreseen within the next year

Recruitment start date

15/04/2006

Recruitment end date

30/03/2011

Locations

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, France, Germany, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, United Kingdom

Trial participating centre

University of Southampton
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24667161

Publication citations

  1. Results

    Bruyère O, Reginster JY, Bellamy N, Chapurlat R, Richette P, Cooper C, , Clinically meaningful effect of strontium ranelate on symptoms in knee osteoarthritis: a responder analysis., Rheumatology (Oxford), 2014, 53, 8, 1457-1464, doi: 10.1093/rheumatology/keu018.

Additional files

Editorial Notes