Condition category
Musculoskeletal Diseases
Date applied
11/03/2010
Date assigned
14/04/2010
Last edited
05/11/2013
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 Feng Chun Zhang

ORCID ID

Contact details

Rheumatology and Clinical Immunology Division
Department of Medicine
Peking Union Medical College Hospital
Chinese Academy of Medical Science
No.1 Shuaifuyuan
Wangfujing
Beijing
100730
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL3-12911-022

Study information

Scientific title

The efficacy and safety of two doses of strontium ranelate versus placebo administered orally for 3 years in the treatment of knee osteoarthritis: a prospective multicentre, international, double-blind, placebo-controlled study

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.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

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

The treatment is composed of two doses of strontium ranelate (1 g and 2 g per day) administered orally for 3 years.

Intervention type

Drug

Phase

Phase III

Drug names

Strontium ranelate

Primary outcome measures

Radiographic assessment of knee osteoarthritis measured up to 36 months

Secondary outcome measures

Measured up to 36 months:
1. Algofunctional assessment
2. Physical examination
3. Safety

Overall trial start date

30/06/2008

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Asia men and women of at least 50 years of age
2. Primary knee osteoarthritis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

450

Participant exclusion criteria

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

Recruitment start date

30/06/2008

Recruitment end date

30/04/2013

Locations

Countries of recruitment

China, Korea, South, Taiwan

Trial participating centre

Rheumatology and Clinical Immunology Division
Beijing
100730
China

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

Publication citations

Additional files

Editorial Notes