The centres actively taking part in the PROFIDYS clinical trial are:
- Edouard Herriot Hospital in Lyon (Pr Roland CHAPURLAT)
- Lariboisière Hospital in Paris (Pr Philippe ORCEL)
- Cochin Hospital in Paris (Pr Christian ROUX)
- Université Catholique in Louvain, Belgium (Pr Jean-Pierre DEVOGELAER)

INFORMATION INTENDED FOR INVESTIGATORS

NEWS

We are pleased to welcome “Assistance Publique des Hôpitaux de Paris” (AP-HP), who joins the group of financiers of the EUROCORES ECT programme. AP-HP  wishes to highlight its willingness to develop its interest in the pan-European clinical trials..

Please find attached the PROFIDYS clinical trial leaflet, a European multicentre clinical trial on fibrous dysplasia of bone:

 PROFIDYS - Download

Please find below the clinical trial Newsletters:

 July 2007 - Download

 December 2007 - Download

 June 2008 - Download

 January 2009 - Download

 July 2009 - Download

SPC for treatment:

 SPC 5 mg

 SPC 30 mg

INFORMATION INTENDED FOR PATIENTS

PROFIDYS is a clinical trial supported by the European Science Foundation. It is made up of 11 centres, spread across Europe. Two countries have started to recruit patients: France and Belgium. Within a few weeks, centres will open in the Netherlands, as well as in England, followed later by some in Germany. Our aim is to bring together 158 patients within 3 years.

What is the treatment proposed?

The treatment is risedronate (ACTONEL®), a second generation bisphosphonate. Its effectiveness has not only been shown in treating Paget’s disease, but also in the treatment and prevention of postmenopausal or steroid therapy induced osteoporosis. Mode of action: the bone is a perpetually rejuvenating tissue. It is constantly being killed and replaced.  ACTONEL® contributes to the increase in bone density as it is a powerful agent in stopping the degradation (resorption) of bone.

What to do if you experience any undesirable effects?

Do not hesitate in contacting your investigator with any questions that you may have, no matter how small. If you see your GP, tell them what treatment you are potentially receiving. Finally, in an emergency, please call the clinical trial coordination centre on 00 33 (0) 4 72 11 74 89, including weekends.

For more information on the clinical trial, please consult the following documents that refer to PROFIDYS.

 ECT EUROCORES Programme

 ESF Programmes - Download

 ESF Article October 2007 - Download

 ESF Insight July 2008

Link to - US National Institutes of Health

 Thank you for participating in the PROFIDYS clinical trial!

The PROFIDYS clinical trial is supported by the European Medical Research Council (EMRC) unit of the European Science Foundation.

 Created: 09 june 2010