Effect of Structum® (chondroitin sulfate) on cartilage volume in knee osteoarthritis

ISRCTN	ISRCTN33423639
DOI	https://doi.org/10.1186/ISRCTN33423639
Protocol serial number	L00023 GE 403
Sponsor	Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
Funder	Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)

Submission date: 28/04/2011
Registration date: 17/06/2011
Last edited: 21/03/2013

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

Contact information

Prof Jean-Jacques Railhac
Scientific

Service Central de Radiologie et dImagerie Médicale
Hôpital Purpan
1 place du Docteur Baylac
Toulouse
31059
France

Study information

Primary study design	Interventional
Study design	Multicentre randomised double-blind placebo-controlled parallel group study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of 12 months treatment with Structum® (chondroitin sulfate) on cartilage volume in knee osteoarthritis patients: a randomised, double-blind, placebo-controlled pilot study using magnetic resonance imaging (MRI)
Study objectives	There is a correlation between clinical symptoms and decrease of cartilage volume in patients suffering from knee osteoarthritis (KOA).
Ethics approval(s)	Advisory Committee for the Protection of Persons in Biomedical Research [Comité Consultatif pour la Protection des Personnes dans la Recherche Biomédicale (Ethics Committee)] of Toulouse 1 approved on 19th May 2004
Health condition(s) or problem(s) studied	Knee osteoarthritis
Intervention	1. Group Structum® : 1 capsule (500mg chondroitin sulfate) two times a day (b.i.d) for 12 months. 2. Group Placebo : 1 capsule Placebo two times a day (b.i.d)
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Structum® (chondroitin sulfate)
Primary outcome measure(s)	The correlation between the evolution of clinical symptoms (Lequesne Index and VAS pain) and the total volume of cartilage after 12 months treatment
Key secondary outcome measure(s)	1. Mean evolution from baseline of the total volume of cartilage and of each knee compartment 2. Evolution of other morphological osteo-articular lesions (sub-chondral oedema, meniscal lesions, synovitis) 3. Mean variation of the pain score (VAS) and of the Lequesne Index 4. Patients and investigators global assessment scores
Completion date	08/06/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Patients aged from 50 to 75 years 2. Symptomatic femorotibial KOA fulfilling American College of Rheumatology (ACR) criteria for KOA 3. A Kellgren-Lawrence radiological grade II or III 4. A global pain score greater than or equal to 30 on a 100mm Visual Analogue Scale (VAS)
Key exclusion criteria	1. Isolated symptomatic femoropatellar osteoarthritis of the knee 2. Inflammatory, infectious or metabolic arthritis 3. Contraindication to MRI examination 4. Intra-articular steroid injection or hyaluronic acid injections in the 3 months preceding inclusion 5. Non steroidal anti-inflammatory drugs (NSAIDs) in the 2 days preceding inclusion
Date of first enrolment	31/08/2004
Date of final enrolment	08/06/2006

Locations

Countries of recruitment

France

Study participating centre

Service Central de Radiologie et dImagerie Médicale

Toulouse
31059
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes