Long-term effects of strontium ranelate on knee osteoarthritis symptoms: a two year prospective, randomised, placebo-controlled study

ISRCTN	ISRCTN33207390
DOI	https://doi.org/10.1186/ISRCTN33207390
Secondary identifying numbers	CL3-12911-028

Submission date: 29/09/2006
Registration date: 12/10/2006
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 JY Reginster
Scientific

Policlinique Brull, 45 Quai Godefroid Kurth
Liège
4020
Belgium

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	Long-term effects of strontium ranelate on knee osteoarthritis symptoms. A 2-year prospective, randomised, placebo-controlled study.
Study objectives	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(s)	Ethics Committee approval obtained on 07/09/2006 (n° 154): Comité dEthique Hospitalo-Facultaire Universitaire de Liège.
Health condition(s) or problem(s) studied	Osteoarthritis
Intervention	Strontium ranelate versus placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Strontium ranelate
Primary outcome measure	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 study start date	30/11/2006
Completion date	30/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	140
Key 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
Key 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
Date of first enrolment	30/11/2006
Date of final enrolment	30/12/2009

Locations

Countries of recruitment

Belgium

Study participating centre

Policlinique Brull, 45 Quai Godefroid Kurth

Liège
4020
Belgium

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	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.

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.
20/12/2017: results summary added.