Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
12/10/2006
Last edited
28/03/2018
Prospective/Retrospective
Prospectively 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 JY Reginster

ORCID ID

Contact details

Policlinique Brull
45 Quai Godefroid Kurth
Liège
4020
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-028

Study information

Scientific title

Long-term effects of strontium ranelate on knee osteoarthritis symptoms. A 2-year prospective, randomised, placebo-controlled study.

Acronym

Study hypothesis

To assess the effectiveness on algofunctional symptoms of knee osteoarthritis.

Please note that as of 27/11/2012, the anticipated end date was updated from 30/06/2009 to 30/12/2009

Ethics approval

Ethics Committee approval obtained on 07/09/2006 (n° 154): Comité d’Ethique Hospitalo-Facultaire Universitaire de Liège.

Study design

Randomised, double-blind, parallel-group, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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

Changes in the algofunctional behaviour of the target knee.

Secondary outcome measures

1. Algofunctional assessment
2. Radiographic assessment of knee osteoarthritis
3. Physical examination

Overall trial start date

30/11/2006

Overall trial end date

30/12/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant 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

Recruitment start date

30/11/2006

Recruitment end date

30/12/2009

Locations

Countries of recruitment

Belgium

Trial participating centre

Policlinique Brull, 45 Quai Godefroid Kurth
Liège
4020
Belgium

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

Publication plan:
Summary results are published on https://clinicaltrials.servier.com.

IPD sharing plan: The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

http://clinicaltrials.servier.com/wp-content/uploads/CL3-12911-028_synopsis_report.pdf

Publication summary

Publication citations

Additional files

Editorial Notes

28/03/2018: Publication plan and IPD sharing statement amended. 24/01/2018: Publication plan and IPD sharing statement added. 20/12/2017: results summary added.