The efficacy and safety of strontium ranelate versus placebo in the treatment of knee osteoarthritis

ISRCTN	ISRCTN92624244
DOI	https://doi.org/10.1186/ISRCTN92624244
Secondary identifying numbers	CL3-12911-022

Submission date: 11/03/2010
Registration date: 14/04/2010
Last edited: 28/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Feng Chun Zhang
Scientific

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

Study information

Study design	Randomised double-blind parallel-group placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ethics approval was obtained before recruitment of the first participants
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Strontium ranelate
Primary outcome measure	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 study start date	30/06/2008
Completion date	30/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	450
Key inclusion criteria	1. Asia men and women of at least 50 years of age 2. Primary knee osteoarthritis
Key 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
Date of first enrolment	30/06/2008
Date of final enrolment	30/04/2013

Locations

Countries of recruitment

China
Korea, South
Taiwan

Study participating centre

Rheumatology and Clinical Immunology Division

Beijing
100730
China

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination 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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No

Editorial Notes

28/03/2018: Publication plan and IPD sharing statement amended.
24/01/2018: Publication plan and IPD sharing statement added.
06/12/2017: results summary added.