Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone (PROFIDYS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014