Trial record 4 of 15 for:
"Fibrous dysplasia"
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone (PROFIDYS)
This study is currently recruiting participants.
Verified March 2010 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00445575
First received: March 8, 2007
Last updated: December 29, 2011
Last verified: March 2010
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Purpose
This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibrous Dysplasia of Bone |
Drug: risedronate Drug: placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone |
Resource links provided by NLM:
Genetics Home Reference related topics:
mucopolysaccharidosis type IV
Drug Information available for:
Risedronate sodium
U.S. FDA Resources
Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:
Primary Outcome Measures:
- Intensity of bone pain, assessed by visual analogical scale ranging from 0 to 10, on the most painful site. [ Time Frame: one year ] [ Designated as safety issue: No ]
- Surface of osteolytic lesions at three years. Radiological improvement. [ Time Frame: Three years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Variation of biochemical markers of bone turnover at three years [ Time Frame: three years ] [ Designated as safety issue: No ]
- Number of painful sites [ Time Frame: one year ] [ Designated as safety issue: No ]
- Improvement in quality of life [ Time Frame: one to three years ] [ Designated as safety issue: No ]
- Variation in bone mineral density of the femoral neck at three years [ Time Frame: three years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 156 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
treatment duration: 1 year
|
Drug: risedronate
During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
|
|
Placebo Comparator: 2
treatment duration: 1 year
|
Drug: placebo
placebo and risedronate have exactly the same aspect. During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
|
|
Experimental: 3
duration treatment: 3 years
|
Drug: risedronate
During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
|
|
Placebo Comparator: 4
treatment duration: 3 years
|
Drug: placebo
placebo and risedronate have exactly the same aspect. During two months courses, every 6 months : 30mg tablet/day for adults and 10mg/day or 20mg/day for children, according to the age and weight of the child.
|
Detailed Description:
In open pilot studies, it has been suggested that bisphosphonates may alleviate bone pain and help decrease the surface of osteolytic lesion in patients with fibrous dysplasia of bone (FD). So, in this randomized placebo controlled trial, we test the hypothesis that the bisphosphonate risedronate reduces bone pain in patients with FD (study I, one year duration) and decrease osteolytic lesions (study II, three years duration). Patients will take risedronate during 2 months courses, every 6 months or a matching placebo. Dosage will be : 30mg tablet/day for adults and 5mg tablet x 2,4 according to the age and weight of the child. All participants will receive calcium and vitamin D. All patients with renal phosphate wasting will receive an oral phosphate supplement.
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Study I: patients with FD, with bone pain intensity above 3 on visual analogical scale from 0 to 10
- Study II: patients with FD with at least one osteolytic lesion and no current bone pain
Exclusion Criteria:
- patients < 8 years old
- other diseases affecting bone metabolism
- patients with malignant diseases or other conditions likely to reduce their life expectancy to less than 3 years
- patients with history of significant upper gastrointestinal disorders
- renal failure (creatinine clearance < 25 ml/mn)
- severe liver disease
- history of iritis or uveitis
- rickets or osteomalacia
- allergy to bisphosphonates
- pregnancy or lactation
- prior treatment with a bisphosphonate
- laboratory abnormalities that may be considered as clinically significant by trial physicians
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445575
Contacts
| Contact: ROLAND D CHAPURLAT, MD PhD | 33472117481 | roland.chapurlat@chu-lyon.fr |
| Contact: CECILE L PELTEKIAN, PhD | 33144236341 | cecile.peltekian@inserm.fr |
Locations
| Belgium | |
| Cliniques Universitaires Saint Luc | Recruiting |
| Brussels, Belgium, 1200 | |
| Contact: JEAN PIERRE DEVOGELAER, MD 3227645390 devogelaer@ruma.ucl.ac.be | |
| France | |
| Hopital E Herriot | Recruiting |
| Lyon, France, 69437 | |
| Contact: ROLAND D CHAPURLAT, MD PhD 33472117481 roland.chapurlat@chu-lyon.fr | |
| Hopital Lariboisiere | Recruiting |
| Paris, France, 75475 | |
| Contact: PHILIPPE ORCEL, MD PhD 33149958631 philippe.orcel@lrb.ap-hop.paris.fr | |
| Hopital Cochin | Recruiting |
| Paris, France, 75679 | |
| Contact: CHRISTIAN ROUX, MD PhD 33158412584 | |
| Germany | |
| Hospital Benjamin Franklin | Not yet recruiting |
| Berlin, Germany, 12200 | |
| Contact: DIETER FELSENBERG, MD PhD 4930844530456 dieter.felsenberg@charite.de | |
| Cologne Clinical Centre | Not yet recruiting |
| Cologne, Germany, 50924 | |
| Contact: Eckhard SCHÖNAU +49 221 4785851 ext 4360 Eckhard.schoenau@uk-koeln.de | |
| Heildeberg Clinical Centre | Not yet recruiting |
| Heidelberg, Germany, 69120 | |
| Contact: Christian KASPERK, MD PhD +49 6221 56 86 05 Christian.kasperk@med.uni-heidelberg.de | |
| Netherlands | |
| Leids Universitair Medisch Centrum | Recruiting |
| Leiden, Netherlands, 2300 | |
| Contact: Neveen HAMDY, MD PhD 31715269111 endocrinologie@lume.nl | |
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
ZonMw: The Netherlands Organisation for Health Research and Development
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Charite University, Berlin, Germany
Investigators
| Principal Investigator: | ROLAND D CHAPURLAT, MD PhD | Institut National de la Santé Et de la Recherche Médicale, France |
| Study Director: | PHILIPPE ORCEL, MD PhD | HOPITAL LARIBOISIERE |
| Study Chair: | SOCRATES D PAPAPOULOS, MD PhD | Leiden University Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Institut National de la Santé Et de la Recherche Médicale, France |
| ClinicalTrials.gov Identifier: | NCT00445575 History of Changes |
| Other Study ID Numbers: | RBM 03-54, AFSSAPS 060834 |
| Study First Received: | March 8, 2007 |
| Last Updated: | December 29, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
|
fibrous dysplasia of bone Mac Cune Albright syndrome bisphosphonates risedronate |
Additional relevant MeSH terms:
|
Fibrous Dysplasia of Bone Fibrosis Hyperplasia Pathologic Processes Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Risedronic acid |
Etidronic Acid Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013