Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Ethics Committee approval obtained on 07/09/2006 (n° 154): Comité dEthique 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
Study setting(s)
Hospital
Study 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
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
Overall study end date
30/12/2009
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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.
Intention to publish date
Individual participant data (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.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No |